Dehydration
Conditions
Keywords
pediatric, hylenex, subcutaneous infusion, hyaluronidase, rHuPH20, recombinant human hyaluronidase
Brief summary
Randomized (1:1 ratio) study of subcutaneous (SC) versus intravenous (IV) fluid rehydration in mildly to moderately dehydrated pediatric patients.
Detailed description
This is a prospective, randomized (1:1 ratio), open-label, parallel group, multicenter, multi-national, study of SC versus IV fluid rehydration in mildly to moderately dehydrated pediatric patients treated in the Emergency Department (ED), inpatient pediatric unit, and/or outpatient urgent care facility. It is expected that up to 186 patients, in order to achieve 148 evaluable patients, will be randomized in a 1:1 ratio to receive isotonic fluid rehydration by either SC administration with hylenex (150 Units) or IV without hylenex.
Interventions
150 Units in 1 mL
Sponsors
Baxter Healthcare Corporation
Halozyme Therapeutics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Days to 10 Years
Healthy volunteers
No
Inclusion criteria
* Children of either gender from one month to ≤10 years of age. * Patients with mild or moderate dehydration * Healthy child except for the underlying etiology for dehydration * Pre-dehydration body weight ≥ 5th percentile for age * Parents or legal guardian(s) available to provide informed consent.
Exclusion criteria
* Severe dehydration * Shock or life-threatening situation (life expectancy \< 10 days). * Requirement for IV access for any indication other than for treatment of dehydration. * Indwelling IV catheter, except for one intended only for collection of clinical laboratory specimens. * Any condition precluding SC infusion or infusion site evaluation * Any reason (prior to study enrollment) for a hospital admission or an extended stay in the ED for other than dehydration. * Known hypersensitivity to hyaluronidase or hylenex. * Known hyponatremia (\< 130 milliequivalents per liter \[mEq/L\]) or hypernatremia (\> 155 mEq/L). * Known hypokalemia (\< 3.0 mEq/L). * Any medical condition likely to interfere with the patient's ability to fully complete all protocol-specified interventions, the ability to undergo all protocol-specified assessments, or likely to prolong the patient's need for medical attention beyond that required for treatment of dehydration. * Participation in an investigational drug or device study within 30 days prior to enrollment in this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Total Volume of Fluid Administered at a Single Infusion Site, From the Start to the Cessation of Fluid Administration, for All Randomized Participants | During the infusion (single bolus dose of hylenex [1 hr], followed by subcutaneous fluid for 1 hour to 72 hours) | It was anticipated that most participants in this study would be hydrated through only one infusion site. For participants who received fluid at more than one administration site, a single infusion site was defined as the anatomical site at which the majority of the total infusion volume was infused. The term anatomical site was designated as: 1) the back; 2) left thigh; 3) right thigh; 4) abdomen; or 5) chest. |
| Mean Total Volume of Fluid Administered at a Single Infusion Site, From the Start to the Cessation of Fluid Administration, for Non-rescued Participants | During the infusion (single bolus dose of hylenex [1 hr], followed by subcutaneous fluid for 1 hour to 72 hours) | It was anticipated that most participants in this study would be hydrated through only one infusion site. For participants who received fluid at more than one administration site, a single infusion site was defined as the anatomical site at which the majority of the total infusion volume was infused. The term anatomical site was designated as: 1) the back; 2) left thigh; 3) right thigh; 4) abdomen; or 5) chest. Participants randomized to receive intravenous isotonic fluid were permitted to receive subcutaneous fluid administration by hylenex-facilitated infusion as rescue. |
| Mean Total Volume of Fluid Administered at a Single Infusion Site, From the Start to the Cessation of Fluid Administration, for All Rescued Participants | During the infusion (single bolus dose of hylenex [1 hr], followed by subcutaneous fluid for 1 hour to 72 hours) | It was anticipated that most participants in this study would be hydrated through only one infusion site. For participants who received fluid at more than one administration site, a single infusion site was defined as the anatomical site at which the majority of the total infusion volume was infused. The term anatomical site was designated as: 1) the back; 2) left thigh; 3) right thigh; 4) abdomen; or 5) chest. Participants randomized to receive intravenous isotonic fluid were permitted to receive subcutaneous fluid administration by hylenex-facilitated infusion as rescue. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Total Volume of Fluid Administered at All Infusion Sites, From the Start to the Cessation of Fluid Administration, for All Rescued Participants Achieving > 200 mL | During the infusion (single bolus dose of hylenex [1 hr], followed by subcutaneous fluid for 1 hour to 72 hours) | It was anticipated that most participants in this study would be hydrated through only one infusion site. For participants who received fluid at more than one administration site, a single infusion site was defined as the anatomical site at which the majority of the total infusion volume was infused. The term anatomical site was designated as: 1) the back; 2) left thigh; 3) right thigh; 4) abdomen; or 5) chest. Participants randomized to receive intravenous isotonic fluid were permitted to receive subcutaneous fluid administration by hylenex-facilitated infusion as rescue. The label for hylenex indicated precautionary wording recommending an upper limit on the volume of fluid (200 mL) administered subcutaneously to infants less than 3 years of age. In October 2008, the FDA removed this wording from the label, thus negating the need for these data and associated analyses. The protocol was amended to reflect this label change; thus, this analysis was not conducted. |
| Mean Flow Rate, Delivered Per Unit Time, for All Randomized Participants | During the infusion (single bolus dose of hylenex [1 hr], followed by subcutaneous fluid for 1 hour to 72 hours) | The mean flow rate was averaged over any 60-minute period of time. |
| Mean Flow Rate, Delivered Per Unit Time, for All Non-rescued Participants | During the infusion (single bolus dose of hylenex [1 hr], followed by subcutaneous fluid for 1 hour to 72 hours) | The mean flow rate was averaged over any 60-minute period of time. Participants randomized to receive intravenous isotonic fluid were permitted to receive subcutaneous fluid administration by hylenex-facilitated infusion as rescue. |
| Mean Flow Rate, Delivered Per Unit Time, for All Rescued Participants | During the infusion (single bolus dose of hylenex [1 hr], followed by subcutaneous fluid for 1 hour to 72 hours) | The mean flow rate was averaged over any 60-minute period of time. Participants randomized to receive intravenous isotonic fluid were permitted to receive subcutaneous fluid administration by hylenex-facilitated infusion as rescue. |
| Mean Flow Rate, Delivered by Volume Per Unit Body Weight Per Unit Time, for All Randomized Participants | During the infusion (single bolus dose of hylenex [1 hr], followed by subcutaneous fluid for 1 hour to 72 hours) | The mean flow rate was averaged over any 60-minute period of time. |
| Mean Flow Rate, Delivered by Volume Per Unit Body Weight Per Unit Time, for All Non-rescued Participants | During the infusion (single bolus dose of hylenex [1 hr], followed by subcutaneous fluid for 1 hour to 72 hours) | The mean flow rate was averaged over any 60-minute period of time. Participants randomized to receive intravenous isotonic fluid were permitted to receive subcutaneous fluid administration by hylenex-facilitated infusion as rescue. |
| Mean Flow Rate, Delivered by Volume Per Unit Body Weight Per Unit Time, for All Rescued Participants | During the infusion (single bolus dose of hylenex [1 hr], followed by subcutaneous fluid for 1 hour to 72 hours) | The mean flow rate was averaged over any 60-minute period of time. Participants randomized to receive intravenous isotonic fluid were permitted to receive subcutaneous fluid administration by hylenex-facilitated infusion as rescue. |
| Number of Participants Achieving a Maximum Flow Rate of > 2 Milliliters Per Minute (mL/Min), as an Indication of Successful Hydration | During the infusion (single bolus dose of hylenex [1 hr], followed by subcutaneous fluid for 1 hour to 72 hours) | The maximum flow rate was averaged over any 60-minute period of time. |
| Number of Participants Administered at Least 200 Milliliter (mL) Total Volume at a Single Infusion Site, From the Start to the Cessation of Fluid Administration | During the infusion (single bolus dose of hylenex [1 hr], followed by subcutaneous fluid for 1 hour to 72 hours) | The number of participants administered at least 20 mL total volume was assessed. |
| Number of Participants With the Indicated Type of Adverse Events | up to 7 days after hospital discharge | Adverse events (AEs) are defined as any untoward medical occurrence in a participant administered a product, which did not necessarily have a causal relationship with the treatment. Treatment-emergent adverse events (TEAEs) are defined as those events that occurred on or after the first injection device insertion attempt. |
| Number of Participants With Normal Physical Examination Findings at Baseline That Shifted to Abnormal at the End of Fluid Administration | Baseline; after infusion (single bolus dose of hylenex [1 hr], followed by subcutaneous fluid for 1 hour to 72 hours) | Baseline was defined as the time prior to the single site fluid infusion. End of infusion was defined as the end of infusion of the single site fluid infusion for participants who had more than one fluid infusion. Not Rel Dehy = Abnormal, Not Related to Dehydration; Rel Dehy = Abnormal, Related to Dehydration. The investigator assessed findings as abnormal. |
| Mean Change From Baseline in Heart Rate | Baseline; after infusion (single bolus dose of hylenex [1 hr], followed by subcutaneous fluid for 1 hour to 72 hours) | Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Baseline was defined as the time prior to the single site fluid infusion. End of infusion was defined as the end of infusion of the single site fluid infusion for participants who had more than one fluid infusion. |
| Mean Change From Baseline in Respiratory Rate | Baseline; after infusion (single bolus dose of hylenex [1 hr], followed by subcutaneous fluid for 1 hour to 72 hours) | Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Baseline was defined as the time prior to the single site fluid infusion. End of infusion was defined as the end of infusion of the single site fluid infusion for participants who had more than one fluid infusion. |
| Mean Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure | Baseline; after infusion (single bolus dose of hylenex [1 hr], followed by subcutaneous fluid for 1 hour to 72 hours) | Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Baseline was defined as the time prior to the single site fluid infusion. End of infusion was defined as the end of infusion of the single site fluid infusion for participants who had more than one fluid infusion. |
| Mean Change From Baseline in the Face, Legs, Activity, Cry, Consolability (FLACC) Pain Scale Score | Before infusion (Baseline); after infusion (single bolus dose of hylenex [1 hr], followed by subcutaneous fluid for 1 hour to 72 hours) | The infusion site was assessed for pain at two time points: after placement of the infusion device but before fluid infusion and at the end of infusion. Pain was recorded using the FLACC pain scale for children less than 3 years of age. Scores on the scale ranged from 0 (no hurt) to 10 (hurt worst). |
| Number of Participants With the Indicated Type of Fluid Administered | During the infusion (single bolus dose of hylenex [1 hr], followed by subcutaneous fluid for 1 hour to 72 hours) | Data are reported for the initial fluid administered. |
| Infusion Duration During the Initial Infusion | first hour of infusion | Infusion duration was assessed as a measure of the time required to complete the initial infusion of 20 mL/kg. |
| Mean Total Volume of Fluid Administered at All Infusion Sites, From the Start to the Cessation of Fluid Administration, for All Randomized Participants | During the infusion (single bolus dose of hylenex [1 hr], followed by subcutaneous fluid for 1 hour to 72 hours) | It was anticipated that most participants in this study would be hydrated through only one infusion site. For participants who received fluid at more than one administration site, a single infusion site was defined as the anatomical site at which the majority of the total infusion volume was infused. The term anatomical site was designated as: 1) the back; 2) left thigh; 3) right thigh; 4) abdomen; or 5) chest. |
| Percent Change From Baseline in Body Weight | Baseline; during the infusion (single bolus dose of hylenex [1 hr], followed by subcutaneous fluid for 1 hour to 72 hours) | Percent change from Baseline was calculated as the (\[post-Baseline value minus the Baseline value\] / Baseline value) \* 100. |
| Number of Participants With the Indicated Type of Rescue Route Therapy Administered | During the infusion (single bolus dose of hylenex [1 hr], followed by subcutaneous fluid for 1 hour to 72 hours) | Participants for whom parenteral access by the randomized route of administration could not be achieved after a reasonable number of attempts and for whom the investigator had deemed the access by that route a failure were expected to receive fluid administration by other means, designated as rescue route for the purpose of this study. This rescue route may have included venous cut-down, central venous line, interosseous access, etc., and for those participants initially randomly assigned to IV fluid administration, SC fluid administration by hylenex-facilitated infusion. |
| Number of Participants Classified With the Indicated Healthcare Provider Responses to the Questions Comprising the Healthcare Provider Global Satisfaction Questionnaire | During the infusion (single bolus dose of hylenex [1 hr], followed by subcutaneous fluid for 1 hour to 72 hours) | A global assessment of overall satisfaction with the rehydration therapy by healthcare provider was performed at the end of SC or IV fluid rehydration utilizing a simple questionnaire. There were separate questionnaires for the two types of rehydration (SC and IV). Question 1: Was the participant successfully hydrated using the randomized route of administration?; Question 2: Overall, was the procedure of fluid infusion easy to perform?; Question 3: Were there any unacceptable side effects from the therapy?; Question 4: Would you consider using this hydration therapy for this indication in the future? |
| Number of Participants Classified With the Indicated Healthcare Provider Responses to the Question: How Does This Therapy Compare to Your Experience With IV (for SC Group) / SC (for IV Group) Therapy? | During the infusion (single bolus dose of hylenex [1 hr], followed by subcutaneous fluid for 1 hour to 72 hours) | A global assessment of overall satisfaction with the rehydration therapy by healthcare provider was performed at the end of SC or IV fluid rehydration utilizing a simple questionnaire. There were separate questionnaires for the two types of rehydration (SC and IV). |
| Number of Participants Classified With the Indicated Parent/Guardian Responses to the Questions Comprising the Parent / Guardian Global Satisfaction Questionnaire | During the infusion (single bolus dose of hylenex [1 hr], followed by subcutaneous fluid for 1 hour to 72 hours) | A global assessment of overall satisfaction with the rehydration therapy by healthcare provider was performed at the end of SC or IV fluid rehydration utilizing a simple questionnaire. There were separate questionnaires for the two types of rehydration (SC and IV). Question 1: Do you believe the method of therapy was successful in your child's rehydration?; Question 2: Have you or your child ever previously had IV fluids (for SC Group) / SC fluids (for IV Group)?; Question 3: If the response to Question 2 was yes, how does this compare to prior experience with IV (for SC Group) / SC (for IV Group)?; Question 4: Should your child(ren) need rehydration treatment in the future, would you opt for this procedure?; Question 5: Should you need rehydration treatment in the future, would you opt for this procedure?; Question 6: What is your global satisfaction with the study procedure? |
| Number of Participants With the Indicated Number of Different Anatomical Administration Sites Needed After the Start of Fluid Administration | During the infusion (single bolus dose of hylenex [1 hr], followed by subcutaneous fluid for 1 hour to 72 hours) | In the event that the degree of local infusion site swelling became unacceptable for any reason (e.g., a 30% or greater increase from the baseline circumference of the infused thigh or in the clinical judgment of the investigator), the infusion rate was decreased or the infusion site was changed. |
| Number of Participants Experiencing Reductions in Flow Rate | During the infusion (single bolus dose of hylenex [1 hr], followed by subcutaneous fluid for 1 hour to 72 hours) | In the event that the degree of local infusion site swelling became unacceptable for any reason (e.g., a 30% or greater increase from the baseline circumference of the infused thigh or in the clinical judgment of the investigator), the infusion rate was decreased or the infusion site was changed. |
| Number of Participants Who Received Needle Placement by People With the Indicated Level of Staff Training | average of approximately 3 minutes | Data were collected for the level of staff training for the person who performed the needle placement. |
| Number of Participants for Which the Indicated Number of Additional Personnel Was Involved in Needle Placement | average of approximately 3 minutes | Data were collected for the number of additional personnel involved in needle placement. |
| Time From the Start of Infusion to the Time of Emergency Department (ED) Discharge | up to approximately 26 hours | Data are reported from the start of infusion to the time of ED discharge. |
| Time From Randomization to the First Drop of Fluid Infusion | up to approximately 110 and 220 minutes for the SC and IV arms, respectively | Data are reported for the time from randomization to the start of fluid infusion for all randomized participants. |
| Number of Participants With the Indicated Number of Needle Stick Attempts Needed to Initiate Fluid Administration | average of approximately 3 minutes | Data are reported for the number of needle stick attempts needed to initiate fluid administration. |
| Number of Participants for Which the Indicated Type of Infusion Device Was Used | average of approximately 3 minutes | Data are reported for the type of infusion device used. |
| Number of Participants for Which the Indicated Gauge for Infusion Device Was Used | average of approximately 3 minutes | Data are reported for the gauge of infusion device used. |
| Number of Participants Discharged From the ED to Home or the Hospital | up to approximately 26 hours | Participants were discharged from the ED to home or the hospital to continue hydration therapy. |
| Number of Participants With the Indicated Reason for Rehospitalization Within 48 and 72 Hours After Discharge | from randomization up to approximately 98 hours | Participants were discharged from the ED to home or the hospital to continue hydration therapy. |
| Change From Baseline in Hydration Status According to the Gorelick Assessment at the End of Fluid Infusion | Baseline; during the infusion (single bolus dose of hylenex [1 hr], followed by subcutaneous fluid for 1 hour to 72 hours) | Hydration status was assessed clinically using the Gorelick 10-item scale: general condition, quality of radial pulse, quality of respiration, skin elasticity, eyes, tears, mucous membranes, urine output, heart rate, and capillary refill time at the fingertip. Scores ranged from 0 (less severe impairment) to 10 (more severe impairment). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. |
| Mean Total Volume of Fluid Administered at All Infusion Sites, From the Start to the Cessation of Fluid Administration, for All Randomized Participants Achieving > 200 mL | During the infusion (single bolus dose of hylenex [1 hr], followed by subcutaneous fluid for 1 hour to 72 hours) | It was anticipated that most participants in this study would be hydrated through only one infusion site. For participants who received fluid at more than one administration site, a single infusion site was defined as the anatomical site at which the majority of the total infusion volume was infused. The term anatomical site was designated as: 1) the back; 2) left thigh; 3) right thigh; 4) abdomen; or 5) chest. The label for hylenex indicated precautionary wording recommending an upper limit on the volume of fluid (200 mL) administered subcutaneously to infants less than 3 years of age. In October 2008, the Food and Drug Administration (FDA) removed this wording from the label, thus negating the need for these data and associated analyses. The protocol was amended to reflect this label change; thus, this analysis was not conducted. |
| Mean Total Volume of Fluid Administered at All Infusion Sites, From the Start to the Cessation of Fluid Administration, for Non-rescued Participants Achieving > 200 mL | During the infusion (single bolus dose of hylenex [1 hr], followed by subcutaneous fluid for 1 hour to 72 hours) | It was anticipated that most participants in this study would be hydrated through only one infusion site. For participants who received fluid at more than one administration site, a single infusion site was defined as the anatomical site at which the majority of the total infusion volume was infused. The term anatomical site was designated as: 1) the back; 2) left thigh; 3) right thigh; 4) abdomen; or 5) chest. Participants randomized to receive intravenous isotonic fluid were permitted to receive subcutaneous fluid administration by hylenex-facilitated infusion as rescue. The label for hylenex indicated precautionary wording recommending an upper limit on the volume of fluid (200 mL) administered subcutaneously to infants less than 3 years of age. In October 2008, the FDA removed this wording from the label, thus negating the need for these data and associated analyses. The protocol was amended to reflect this label change; thus, this analysis was not conducted. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Subcutaneous Hylenex Participants received isotonic fluid rehydration by subcutaneous administration with recombinant human hyaluronidase (hylenex: 150 Units in 1 milliliter \[mL\]). | 73 |
| Intravenous Isotonic Fluid Participants received isotonic fluid rehydration by intravenous injection. | 75 |
| Total | 148 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 2 | 0 |
| Overall Study | Consent Withdrawn | 0 | 2 |
Baseline characteristics
| Characteristic | Intravenous Isotonic Fluid | Total | Subcutaneous Hylenex |
|---|---|---|---|
| Age, Continuous | 2.4 years STANDARD_DEVIATION 2.07 | 2.3 years STANDARD_DEVIATION 1.91 | 2.1 years STANDARD_DEVIATION 1.72 |
| Race/Ethnicity, Customized American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Black or African American | 22 Participants | 47 Participants | 25 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Pacific Islander | 1 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Unknown | 12 Participants | 21 Participants | 9 Participants |
| Race/Ethnicity, Customized White | 40 Participants | 79 Participants | 39 Participants |
| Sex: Female, Male Female | 36 Participants | 75 Participants | 39 Participants |
| Sex: Female, Male Male | 39 Participants | 73 Participants | 34 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 73 | 0 / 75 |
| other Total, other adverse events | 73 / 73 | 62 / 75 |
| serious Total, serious adverse events | 3 / 73 | 4 / 75 |
Outcome results
Primary
Mean Total Volume of Fluid Administered at a Single Infusion Site, From the Start to the Cessation of Fluid Administration, for All Randomized Participants
It was anticipated that most participants in this study would be hydrated through only one infusion site. For participants who received fluid at more than one administration site, a single infusion site was defined as the anatomical site at which the majority of the total infusion volume was infused. The term anatomical site was designated as: 1) the back; 2) left thigh; 3) right thigh; 4) abdomen; or 5) chest.
Time frame: During the infusion (single bolus dose of hylenex [1 hr], followed by subcutaneous fluid for 1 hour to 72 hours)
Population: Intent-to-Treat (ITT) Population: all randomly assigned participants for whom the treatment was attempted, (i.e., infusion device placement was initiated)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Subcutaneous Hylenex | Mean Total Volume of Fluid Administered at a Single Infusion Site, From the Start to the Cessation of Fluid Administration, for All Randomized Participants | Emergency department plus hospital stay | 365.0 milliliters | Standard Deviation 324.57 |
| Subcutaneous Hylenex | Mean Total Volume of Fluid Administered at a Single Infusion Site, From the Start to the Cessation of Fluid Administration, for All Randomized Participants | Emergency department stay only | 334.3 milliliters | Standard Deviation 226.4 |
| Intravenous Isotonic Fluid | Mean Total Volume of Fluid Administered at a Single Infusion Site, From the Start to the Cessation of Fluid Administration, for All Randomized Participants | Emergency department plus hospital stay | 455.8 milliliters | Standard Deviation 597.43 |
| Intravenous Isotonic Fluid | Mean Total Volume of Fluid Administered at a Single Infusion Site, From the Start to the Cessation of Fluid Administration, for All Randomized Participants | Emergency department stay only | 299.6 milliliters | Standard Deviation 252.33 |
p-value: 0.506495% CI: [-221.2, 86.2]ANOVA
p-value: 0.032595% CI: [-54.6, 102.7]ANOVA
Primary
Mean Total Volume of Fluid Administered at a Single Infusion Site, From the Start to the Cessation of Fluid Administration, for All Rescued Participants
It was anticipated that most participants in this study would be hydrated through only one infusion site. For participants who received fluid at more than one administration site, a single infusion site was defined as the anatomical site at which the majority of the total infusion volume was infused. The term anatomical site was designated as: 1) the back; 2) left thigh; 3) right thigh; 4) abdomen; or 5) chest. Participants randomized to receive intravenous isotonic fluid were permitted to receive subcutaneous fluid administration by hylenex-facilitated infusion as rescue.
Time frame: During the infusion (single bolus dose of hylenex [1 hr], followed by subcutaneous fluid for 1 hour to 72 hours)
Population: ITT Population. Only those participants for which fluid administration was initiated were analyzed. Only those participants randomized to receive intravenous isotonic fluid who received subcutaneous fluid administration by hylenex-facilitated infusion as rescue were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Subcutaneous Hylenex | Mean Total Volume of Fluid Administered at a Single Infusion Site, From the Start to the Cessation of Fluid Administration, for All Rescued Participants | Emergency department plus hospital stay | 388.3 milliliters | Standard Deviation 281.13 |
| Subcutaneous Hylenex | Mean Total Volume of Fluid Administered at a Single Infusion Site, From the Start to the Cessation of Fluid Administration, for All Rescued Participants | Emergency department stay only | 315.3 milliliters | Standard Deviation 150.38 |
Primary
Mean Total Volume of Fluid Administered at a Single Infusion Site, From the Start to the Cessation of Fluid Administration, for Non-rescued Participants
It was anticipated that most participants in this study would be hydrated through only one infusion site. For participants who received fluid at more than one administration site, a single infusion site was defined as the anatomical site at which the majority of the total infusion volume was infused. The term anatomical site was designated as: 1) the back; 2) left thigh; 3) right thigh; 4) abdomen; or 5) chest. Participants randomized to receive intravenous isotonic fluid were permitted to receive subcutaneous fluid administration by hylenex-facilitated infusion as rescue.
Time frame: During the infusion (single bolus dose of hylenex [1 hr], followed by subcutaneous fluid for 1 hour to 72 hours)
Population: ITT Population. Only those participants for which fluid administration was initiated were analyzed. Only those participants who did not receive subcutaneous fluid administration by hylenex-facilitated infusion as rescue were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Subcutaneous Hylenex | Mean Total Volume of Fluid Administered at a Single Infusion Site, From the Start to the Cessation of Fluid Administration, for Non-rescued Participants | Emergency department plus hospital stay | 365.0 milliliters | Standard Deviation 324.57 |
| Subcutaneous Hylenex | Mean Total Volume of Fluid Administered at a Single Infusion Site, From the Start to the Cessation of Fluid Administration, for Non-rescued Participants | Emergency department stay only | 334.3 milliliters | Standard Deviation 226.4 |
| Intravenous Isotonic Fluid | Mean Total Volume of Fluid Administered at a Single Infusion Site, From the Start to the Cessation of Fluid Administration, for Non-rescued Participants | Emergency department plus hospital stay | 579.4 milliliters | Standard Deviation 618.49 |
| Intravenous Isotonic Fluid | Mean Total Volume of Fluid Administered at a Single Infusion Site, From the Start to the Cessation of Fluid Administration, for Non-rescued Participants | Emergency department stay only | 380.8 milliliters | Standard Deviation 223.08 |
p-value: 0.891595% CI: [-340.3, -9.1]ANOVA
p-value: 0.546995% CI: [-137.5, 20.3]ANOVA
Secondary
Change From Baseline in Hydration Status According to the Gorelick Assessment at the End of Fluid Infusion
Hydration status was assessed clinically using the Gorelick 10-item scale: general condition, quality of radial pulse, quality of respiration, skin elasticity, eyes, tears, mucous membranes, urine output, heart rate, and capillary refill time at the fingertip. Scores ranged from 0 (less severe impairment) to 10 (more severe impairment). Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Time frame: Baseline; during the infusion (single bolus dose of hylenex [1 hr], followed by subcutaneous fluid for 1 hour to 72 hours)
Population: ITT Population. Only those participants contributing data at the indicated time point were assessed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Subcutaneous Hylenex | Change From Baseline in Hydration Status According to the Gorelick Assessment at the End of Fluid Infusion | -2.6 score on a scale | Standard Deviation 1.26 |
| Intravenous Isotonic Fluid | Change From Baseline in Hydration Status According to the Gorelick Assessment at the End of Fluid Infusion | -2.2 score on a scale | Standard Deviation 1.64 |
p-value: 0.065895% CI: [-0.9, 0]ANOVA
Secondary
Infusion Duration During the Initial Infusion
Infusion duration was assessed as a measure of the time required to complete the initial infusion of 20 mL/kg.
Time frame: first hour of infusion
Population: ITT Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Subcutaneous Hylenex | Infusion Duration During the Initial Infusion | 1.0 hours | Standard Deviation 0.13 |
| Intravenous Isotonic Fluid | Infusion Duration During the Initial Infusion | 0.8 hours | Standard Deviation 0.42 |
95% CI: [0.1, 0.3]
Secondary
Mean Change From Baseline in Heart Rate
Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Baseline was defined as the time prior to the single site fluid infusion. End of infusion was defined as the end of infusion of the single site fluid infusion for participants who had more than one fluid infusion.
Time frame: Baseline; after infusion (single bolus dose of hylenex [1 hr], followed by subcutaneous fluid for 1 hour to 72 hours)
Population: Safety Population. Only those participants with available data were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Subcutaneous Hylenex | Mean Change From Baseline in Heart Rate | -6.9 beats per minute | Standard Deviation 17.38 |
| Intravenous Isotonic Fluid | Mean Change From Baseline in Heart Rate | -4.8 beats per minute | Standard Deviation 18.64 |
| Intravenous Isotonic Fluid: SC Rescued | Mean Change From Baseline in Heart Rate | -11.3 beats per minute | Standard Deviation 24.68 |
Secondary
Mean Change From Baseline in Respiratory Rate
Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Baseline was defined as the time prior to the single site fluid infusion. End of infusion was defined as the end of infusion of the single site fluid infusion for participants who had more than one fluid infusion.
Time frame: Baseline; after infusion (single bolus dose of hylenex [1 hr], followed by subcutaneous fluid for 1 hour to 72 hours)
Population: Safety Population. Only those participants with available data were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Subcutaneous Hylenex | Mean Change From Baseline in Respiratory Rate | -4.8 breaths per minute | Standard Deviation 9.76 |
| Intravenous Isotonic Fluid | Mean Change From Baseline in Respiratory Rate | -1.3 breaths per minute | Standard Deviation 7.96 |
| Intravenous Isotonic Fluid: SC Rescued | Mean Change From Baseline in Respiratory Rate | -2.6 breaths per minute | Standard Deviation 13.36 |
Secondary
Mean Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure
Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Baseline was defined as the time prior to the single site fluid infusion. End of infusion was defined as the end of infusion of the single site fluid infusion for participants who had more than one fluid infusion.
Time frame: Baseline; after infusion (single bolus dose of hylenex [1 hr], followed by subcutaneous fluid for 1 hour to 72 hours)
Population: Safety Population. Only those participants with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Subcutaneous Hylenex | Mean Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure | Systolic blood pressure | 3.2 millimeters of mercury (mmHg) | Standard Deviation 16.15 |
| Subcutaneous Hylenex | Mean Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure | Diastolic blood pressure | -0.2 millimeters of mercury (mmHg) | Standard Deviation 12.43 |
| Intravenous Isotonic Fluid | Mean Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure | Systolic blood pressure | 1.1 millimeters of mercury (mmHg) | Standard Deviation 15.49 |
| Intravenous Isotonic Fluid | Mean Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure | Diastolic blood pressure | 0.7 millimeters of mercury (mmHg) | Standard Deviation 12.45 |
| Intravenous Isotonic Fluid: SC Rescued | Mean Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure | Systolic blood pressure | -4.0 millimeters of mercury (mmHg) | Standard Deviation 24.17 |
| Intravenous Isotonic Fluid: SC Rescued | Mean Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure | Diastolic blood pressure | -2.9 millimeters of mercury (mmHg) | Standard Deviation 23.07 |
Secondary
Mean Change From Baseline in the Face, Legs, Activity, Cry, Consolability (FLACC) Pain Scale Score
The infusion site was assessed for pain at two time points: after placement of the infusion device but before fluid infusion and at the end of infusion. Pain was recorded using the FLACC pain scale for children less than 3 years of age. Scores on the scale ranged from 0 (no hurt) to 10 (hurt worst).
Time frame: Before infusion (Baseline); after infusion (single bolus dose of hylenex [1 hr], followed by subcutaneous fluid for 1 hour to 72 hours)
Population: Safety Population. Only those participants with available data were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Subcutaneous Hylenex | Mean Change From Baseline in the Face, Legs, Activity, Cry, Consolability (FLACC) Pain Scale Score | -4.4 score on a scale | Standard Deviation 3.45 |
| Intravenous Isotonic Fluid | Mean Change From Baseline in the Face, Legs, Activity, Cry, Consolability (FLACC) Pain Scale Score | -5.2 score on a scale | Standard Deviation 2.94 |
| Intravenous Isotonic Fluid: SC Rescued | Mean Change From Baseline in the Face, Legs, Activity, Cry, Consolability (FLACC) Pain Scale Score | -3.8 score on a scale | Standard Deviation 2.11 |
Secondary
Mean Flow Rate, Delivered by Volume Per Unit Body Weight Per Unit Time, for All Non-rescued Participants
The mean flow rate was averaged over any 60-minute period of time. Participants randomized to receive intravenous isotonic fluid were permitted to receive subcutaneous fluid administration by hylenex-facilitated infusion as rescue.
Time frame: During the infusion (single bolus dose of hylenex [1 hr], followed by subcutaneous fluid for 1 hour to 72 hours)
Population: ITT Population. Only those participants who did not receive subcutaneous fluid administration by hylenex-facilitated infusion as rescue were analyzed. Only those participants with evaluable data (known volume and known baseline body weight) were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Subcutaneous Hylenex | Mean Flow Rate, Delivered by Volume Per Unit Body Weight Per Unit Time, for All Non-rescued Participants | Emergency department plus hospital stay | 15.4 milliliters per kilogram per hour | Standard Deviation 5.62 |
| Subcutaneous Hylenex | Mean Flow Rate, Delivered by Volume Per Unit Body Weight Per Unit Time, for All Non-rescued Participants | Emergency department stay only | 15.6 milliliters per kilogram per hour | Standard Deviation 5.33 |
| Intravenous Isotonic Fluid | Mean Flow Rate, Delivered by Volume Per Unit Body Weight Per Unit Time, for All Non-rescued Participants | Emergency department plus hospital stay | 15.7 milliliters per kilogram per hour | Standard Deviation 7.8 |
| Intravenous Isotonic Fluid | Mean Flow Rate, Delivered by Volume Per Unit Body Weight Per Unit Time, for All Non-rescued Participants | Emergency department stay only | 17.1 milliliters per kilogram per hour | Standard Deviation 7.14 |
95% CI: [-2.8, 1.9]
95% CI: [-3.4, 0.8]
Secondary
Mean Flow Rate, Delivered by Volume Per Unit Body Weight Per Unit Time, for All Randomized Participants
The mean flow rate was averaged over any 60-minute period of time.
Time frame: During the infusion (single bolus dose of hylenex [1 hr], followed by subcutaneous fluid for 1 hour to 72 hours)
Population: ITT Population. Only those participants with evaluable data (known volume and known baseline body weight) were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Subcutaneous Hylenex | Mean Flow Rate, Delivered by Volume Per Unit Body Weight Per Unit Time, for All Randomized Participants | Emergency department plus hospital stay | 15.4 milliliters per kilogram per hour | Standard Deviation 5.62 |
| Subcutaneous Hylenex | Mean Flow Rate, Delivered by Volume Per Unit Body Weight Per Unit Time, for All Randomized Participants | Emergency department stay only | 15.6 milliliters per kilogram per hour | Standard Deviation 5.33 |
| Intravenous Isotonic Fluid | Mean Flow Rate, Delivered by Volume Per Unit Body Weight Per Unit Time, for All Randomized Participants | Emergency department plus hospital stay | 12.3 milliliters per kilogram per hour | Standard Deviation 9.5 |
| Intravenous Isotonic Fluid | Mean Flow Rate, Delivered by Volume Per Unit Body Weight Per Unit Time, for All Randomized Participants | Emergency department stay only | 13.3 milliliters per kilogram per hour | Standard Deviation 9.5 |
95% CI: [0.3, 5.5]
95% CI: [-0.2, 4.7]
Secondary
Mean Flow Rate, Delivered by Volume Per Unit Body Weight Per Unit Time, for All Rescued Participants
The mean flow rate was averaged over any 60-minute period of time. Participants randomized to receive intravenous isotonic fluid were permitted to receive subcutaneous fluid administration by hylenex-facilitated infusion as rescue.
Time frame: During the infusion (single bolus dose of hylenex [1 hr], followed by subcutaneous fluid for 1 hour to 72 hours)
Population: ITT Population. Only those participants randomized to receive intravenous isotonic fluid who received subcutaneous fluid administration by hylenex-facilitated infusion as rescue were analyzed. Only those participants with evaluable data (known volume and known baseline body weight) were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Subcutaneous Hylenex | Mean Flow Rate, Delivered by Volume Per Unit Body Weight Per Unit Time, for All Rescued Participants | Emergency department plus hospital stay | 14.4 milliliters per kilogram per hour | Standard Deviation 6.47 |
| Subcutaneous Hylenex | Mean Flow Rate, Delivered by Volume Per Unit Body Weight Per Unit Time, for All Rescued Participants | Emergency department stay only | 15.4 milliliters per kilogram per hour | Standard Deviation 6.07 |
Secondary
Mean Flow Rate, Delivered Per Unit Time, for All Non-rescued Participants
The mean flow rate was averaged over any 60-minute period of time. Participants randomized to receive intravenous isotonic fluid were permitted to receive subcutaneous fluid administration by hylenex-facilitated infusion as rescue.
Time frame: During the infusion (single bolus dose of hylenex [1 hr], followed by subcutaneous fluid for 1 hour to 72 hours)
Population: ITT Population. Only those participants for which fluid administration was initiated were analyzed. Only those participants who did not receive subcutaneous fluid administration by hylenex-facilitated infusion as rescue were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Subcutaneous Hylenex | Mean Flow Rate, Delivered Per Unit Time, for All Non-rescued Participants | Emergency department plus hospital stay | 183.8 milliliters per hour | Standard Deviation 94.61 |
| Subcutaneous Hylenex | Mean Flow Rate, Delivered Per Unit Time, for All Non-rescued Participants | Emergency department stay only | 186.4 milliliters per hour | Standard Deviation 92.21 |
| Intravenous Isotonic Fluid | Mean Flow Rate, Delivered Per Unit Time, for All Non-rescued Participants | Emergency department plus hospital stay | 211.1 milliliters per hour | Standard Deviation 127.44 |
| Intravenous Isotonic Fluid | Mean Flow Rate, Delivered Per Unit Time, for All Non-rescued Participants | Emergency department stay only | 228.3 milliliters per hour | Standard Deviation 118.82 |
95% CI: [-69.5, 9.4]
95% CI: [-77.3, -3.1]
Secondary
Mean Flow Rate, Delivered Per Unit Time, for All Randomized Participants
The mean flow rate was averaged over any 60-minute period of time.
Time frame: During the infusion (single bolus dose of hylenex [1 hr], followed by subcutaneous fluid for 1 hour to 72 hours)
Population: ITT Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Subcutaneous Hylenex | Mean Flow Rate, Delivered Per Unit Time, for All Randomized Participants | Emergency department plus hospital stay | 183.8 milliliters per hour | Standard Deviation 94.61 |
| Subcutaneous Hylenex | Mean Flow Rate, Delivered Per Unit Time, for All Randomized Participants | Emergency department stay only | 186.4 milliliters per hour | Standard Deviation 92.21 |
| Intravenous Isotonic Fluid | Mean Flow Rate, Delivered Per Unit Time, for All Randomized Participants | Emergency department plus hospital stay | 166.1 milliliters per hour | Standard Deviation 142.52 |
| Intravenous Isotonic Fluid | Mean Flow Rate, Delivered Per Unit Time, for All Randomized Participants | Emergency department stay only | 179.6 milliliters per hour | Standard Deviation 141.19 |
95% CI: [-69.5, 9.4]
95% CI: [-77.3, -3.1]
Secondary
Mean Flow Rate, Delivered Per Unit Time, for All Rescued Participants
The mean flow rate was averaged over any 60-minute period of time. Participants randomized to receive intravenous isotonic fluid were permitted to receive subcutaneous fluid administration by hylenex-facilitated infusion as rescue.
Time frame: During the infusion (single bolus dose of hylenex [1 hr], followed by subcutaneous fluid for 1 hour to 72 hours)
Population: ITT Population. Only those participants for which fluid administration was initiated were analyzed. Only those participants randomized to receive intravenous isotonic fluid who received subcutaneous fluid administration by hylenex-facilitated infusion as rescue were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Subcutaneous Hylenex | Mean Flow Rate, Delivered Per Unit Time, for All Rescued Participants | Emergency department plus hospital stay | 139.1 milliliters per hour | Standard Deviation 80.27 |
| Subcutaneous Hylenex | Mean Flow Rate, Delivered Per Unit Time, for All Rescued Participants | Emergency department stay only | 149.8 milliliters per hour | Standard Deviation 79.53 |
Secondary
Mean Total Volume of Fluid Administered at All Infusion Sites, From the Start to the Cessation of Fluid Administration, for All Randomized Participants
It was anticipated that most participants in this study would be hydrated through only one infusion site. For participants who received fluid at more than one administration site, a single infusion site was defined as the anatomical site at which the majority of the total infusion volume was infused. The term anatomical site was designated as: 1) the back; 2) left thigh; 3) right thigh; 4) abdomen; or 5) chest.
Time frame: During the infusion (single bolus dose of hylenex [1 hr], followed by subcutaneous fluid for 1 hour to 72 hours)
Population: ITT Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Subcutaneous Hylenex | Mean Total Volume of Fluid Administered at All Infusion Sites, From the Start to the Cessation of Fluid Administration, for All Randomized Participants | Emergency department plus hospital stay | 365.4 milliliters | Standard Deviation 324.21 |
| Subcutaneous Hylenex | Mean Total Volume of Fluid Administered at All Infusion Sites, From the Start to the Cessation of Fluid Administration, for All Randomized Participants | Emergency department stay only | 334.7 milliliters | Standard Deviation 225.94 |
| Intravenous Isotonic Fluid | Mean Total Volume of Fluid Administered at All Infusion Sites, From the Start to the Cessation of Fluid Administration, for All Randomized Participants | Emergency department plus hospital stay | 455.8 milliliters | Standard Deviation 597.43 |
| Intravenous Isotonic Fluid | Mean Total Volume of Fluid Administered at All Infusion Sites, From the Start to the Cessation of Fluid Administration, for All Randomized Participants | Emergency department stay only | 299.6 milliliters | Standard Deviation 252.33 |
p-value: 0.503595% CI: [-220.6, 86.7]ANOVA
p-value: 0.031495% CI: [-54, 103.2]ANOVA
Secondary
Mean Total Volume of Fluid Administered at All Infusion Sites, From the Start to the Cessation of Fluid Administration, for All Randomized Participants Achieving > 200 mL
It was anticipated that most participants in this study would be hydrated through only one infusion site. For participants who received fluid at more than one administration site, a single infusion site was defined as the anatomical site at which the majority of the total infusion volume was infused. The term anatomical site was designated as: 1) the back; 2) left thigh; 3) right thigh; 4) abdomen; or 5) chest. The label for hylenex indicated precautionary wording recommending an upper limit on the volume of fluid (200 mL) administered subcutaneously to infants less than 3 years of age. In October 2008, the Food and Drug Administration (FDA) removed this wording from the label, thus negating the need for these data and associated analyses. The protocol was amended to reflect this label change; thus, this analysis was not conducted.
Time frame: During the infusion (single bolus dose of hylenex [1 hr], followed by subcutaneous fluid for 1 hour to 72 hours)
Population: Randomized Population: all participants who were assigned a patient randomization number
Secondary
Mean Total Volume of Fluid Administered at All Infusion Sites, From the Start to the Cessation of Fluid Administration, for All Rescued Participants Achieving > 200 mL
It was anticipated that most participants in this study would be hydrated through only one infusion site. For participants who received fluid at more than one administration site, a single infusion site was defined as the anatomical site at which the majority of the total infusion volume was infused. The term anatomical site was designated as: 1) the back; 2) left thigh; 3) right thigh; 4) abdomen; or 5) chest. Participants randomized to receive intravenous isotonic fluid were permitted to receive subcutaneous fluid administration by hylenex-facilitated infusion as rescue. The label for hylenex indicated precautionary wording recommending an upper limit on the volume of fluid (200 mL) administered subcutaneously to infants less than 3 years of age. In October 2008, the FDA removed this wording from the label, thus negating the need for these data and associated analyses. The protocol was amended to reflect this label change; thus, this analysis was not conducted.
Time frame: During the infusion (single bolus dose of hylenex [1 hr], followed by subcutaneous fluid for 1 hour to 72 hours)
Population: Randomized Participants. Only those participants randomized to receive intravenous isotonic fluid who received subcutaneous fluid administration by hylenex-facilitated infusion as rescue were analyzed.
Secondary
Mean Total Volume of Fluid Administered at All Infusion Sites, From the Start to the Cessation of Fluid Administration, for Non-rescued Participants Achieving > 200 mL
It was anticipated that most participants in this study would be hydrated through only one infusion site. For participants who received fluid at more than one administration site, a single infusion site was defined as the anatomical site at which the majority of the total infusion volume was infused. The term anatomical site was designated as: 1) the back; 2) left thigh; 3) right thigh; 4) abdomen; or 5) chest. Participants randomized to receive intravenous isotonic fluid were permitted to receive subcutaneous fluid administration by hylenex-facilitated infusion as rescue. The label for hylenex indicated precautionary wording recommending an upper limit on the volume of fluid (200 mL) administered subcutaneously to infants less than 3 years of age. In October 2008, the FDA removed this wording from the label, thus negating the need for these data and associated analyses. The protocol was amended to reflect this label change; thus, this analysis was not conducted.
Time frame: During the infusion (single bolus dose of hylenex [1 hr], followed by subcutaneous fluid for 1 hour to 72 hours)
Population: Randomized Population. Only those participants who did not receive subcutaneous fluid administration by hylenex-facilitated infusion as rescue were to be analyzed.
Secondary
Number of Participants Achieving a Maximum Flow Rate of > 2 Milliliters Per Minute (mL/Min), as an Indication of Successful Hydration
The maximum flow rate was averaged over any 60-minute period of time.
Time frame: During the infusion (single bolus dose of hylenex [1 hr], followed by subcutaneous fluid for 1 hour to 72 hours)
Population: ITT Population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Subcutaneous Hylenex | Number of Participants Achieving a Maximum Flow Rate of > 2 Milliliters Per Minute (mL/Min), as an Indication of Successful Hydration | 68 Participants |
| Intravenous Isotonic Fluid | Number of Participants Achieving a Maximum Flow Rate of > 2 Milliliters Per Minute (mL/Min), as an Indication of Successful Hydration | 57 Participants |
Secondary
Number of Participants Administered at Least 200 Milliliter (mL) Total Volume at a Single Infusion Site, From the Start to the Cessation of Fluid Administration
The number of participants administered at least 20 mL total volume was assessed.
Time frame: During the infusion (single bolus dose of hylenex [1 hr], followed by subcutaneous fluid for 1 hour to 72 hours)
Population: ITT Population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Subcutaneous Hylenex | Number of Participants Administered at Least 200 Milliliter (mL) Total Volume at a Single Infusion Site, From the Start to the Cessation of Fluid Administration | 18 Participants |
| Intravenous Isotonic Fluid | Number of Participants Administered at Least 200 Milliliter (mL) Total Volume at a Single Infusion Site, From the Start to the Cessation of Fluid Administration | 27 Participants |
Secondary
Number of Participants Classified With the Indicated Healthcare Provider Responses to the Question: How Does This Therapy Compare to Your Experience With IV (for SC Group) / SC (for IV Group) Therapy?
A global assessment of overall satisfaction with the rehydration therapy by healthcare provider was performed at the end of SC or IV fluid rehydration utilizing a simple questionnaire. There were separate questionnaires for the two types of rehydration (SC and IV).
Time frame: During the infusion (single bolus dose of hylenex [1 hr], followed by subcutaneous fluid for 1 hour to 72 hours)
Population: ITT Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Subcutaneous Hylenex | Number of Participants Classified With the Indicated Healthcare Provider Responses to the Question: How Does This Therapy Compare to Your Experience With IV (for SC Group) / SC (for IV Group) Therapy? | Effectiveness: Less Effective | 3 Participants |
| Subcutaneous Hylenex | Number of Participants Classified With the Indicated Healthcare Provider Responses to the Question: How Does This Therapy Compare to Your Experience With IV (for SC Group) / SC (for IV Group) Therapy? | Degree of Difficulty: Same Difficulty | 11 Participants |
| Subcutaneous Hylenex | Number of Participants Classified With the Indicated Healthcare Provider Responses to the Question: How Does This Therapy Compare to Your Experience With IV (for SC Group) / SC (for IV Group) Therapy? | Effectiveness: Same Effectiveness | 58 Participants |
| Subcutaneous Hylenex | Number of Participants Classified With the Indicated Healthcare Provider Responses to the Question: How Does This Therapy Compare to Your Experience With IV (for SC Group) / SC (for IV Group) Therapy? | Degree of Difficulty: More Difficult | 3 Participants |
| Subcutaneous Hylenex | Number of Participants Classified With the Indicated Healthcare Provider Responses to the Question: How Does This Therapy Compare to Your Experience With IV (for SC Group) / SC (for IV Group) Therapy? | Effectiveness: Missing | 1 Participants |
| Subcutaneous Hylenex | Number of Participants Classified With the Indicated Healthcare Provider Responses to the Question: How Does This Therapy Compare to Your Experience With IV (for SC Group) / SC (for IV Group) Therapy? | Degree of Difficulty: Missing | 2 Participants |
| Subcutaneous Hylenex | Number of Participants Classified With the Indicated Healthcare Provider Responses to the Question: How Does This Therapy Compare to Your Experience With IV (for SC Group) / SC (for IV Group) Therapy? | Degree of Difficulty: Less Difficult | 57 Participants |
| Subcutaneous Hylenex | Number of Participants Classified With the Indicated Healthcare Provider Responses to the Question: How Does This Therapy Compare to Your Experience With IV (for SC Group) / SC (for IV Group) Therapy? | Not applicable: no prior experience with alternate | 0 Participants |
| Subcutaneous Hylenex | Number of Participants Classified With the Indicated Healthcare Provider Responses to the Question: How Does This Therapy Compare to Your Experience With IV (for SC Group) / SC (for IV Group) Therapy? | Effectiveness: More Effective | 11 Participants |
| Intravenous Isotonic Fluid | Number of Participants Classified With the Indicated Healthcare Provider Responses to the Question: How Does This Therapy Compare to Your Experience With IV (for SC Group) / SC (for IV Group) Therapy? | Not applicable: no prior experience with alternate | 33 Participants |
| Intravenous Isotonic Fluid | Number of Participants Classified With the Indicated Healthcare Provider Responses to the Question: How Does This Therapy Compare to Your Experience With IV (for SC Group) / SC (for IV Group) Therapy? | Effectiveness: Missing | 0 Participants |
| Intravenous Isotonic Fluid | Number of Participants Classified With the Indicated Healthcare Provider Responses to the Question: How Does This Therapy Compare to Your Experience With IV (for SC Group) / SC (for IV Group) Therapy? | Effectiveness: Less Effective | 1 Participants |
| Intravenous Isotonic Fluid | Number of Participants Classified With the Indicated Healthcare Provider Responses to the Question: How Does This Therapy Compare to Your Experience With IV (for SC Group) / SC (for IV Group) Therapy? | Effectiveness: Same Effectiveness | 41 Participants |
| Intravenous Isotonic Fluid | Number of Participants Classified With the Indicated Healthcare Provider Responses to the Question: How Does This Therapy Compare to Your Experience With IV (for SC Group) / SC (for IV Group) Therapy? | Effectiveness: More Effective | 0 Participants |
| Intravenous Isotonic Fluid | Number of Participants Classified With the Indicated Healthcare Provider Responses to the Question: How Does This Therapy Compare to Your Experience With IV (for SC Group) / SC (for IV Group) Therapy? | Degree of Difficulty: Less Difficult | 2 Participants |
| Intravenous Isotonic Fluid | Number of Participants Classified With the Indicated Healthcare Provider Responses to the Question: How Does This Therapy Compare to Your Experience With IV (for SC Group) / SC (for IV Group) Therapy? | Degree of Difficulty: Same Difficulty | 12 Participants |
| Intravenous Isotonic Fluid | Number of Participants Classified With the Indicated Healthcare Provider Responses to the Question: How Does This Therapy Compare to Your Experience With IV (for SC Group) / SC (for IV Group) Therapy? | Degree of Difficulty: More Difficult | 28 Participants |
| Intravenous Isotonic Fluid | Number of Participants Classified With the Indicated Healthcare Provider Responses to the Question: How Does This Therapy Compare to Your Experience With IV (for SC Group) / SC (for IV Group) Therapy? | Degree of Difficulty: Missing | 0 Participants |
p-value: 0.0033Cochran-Mantel-Haenszel
p-value: <0.0001Cochran-Mantel-Haenszel
Secondary
Number of Participants Classified With the Indicated Healthcare Provider Responses to the Questions Comprising the Healthcare Provider Global Satisfaction Questionnaire
A global assessment of overall satisfaction with the rehydration therapy by healthcare provider was performed at the end of SC or IV fluid rehydration utilizing a simple questionnaire. There were separate questionnaires for the two types of rehydration (SC and IV). Question 1: Was the participant successfully hydrated using the randomized route of administration?; Question 2: Overall, was the procedure of fluid infusion easy to perform?; Question 3: Were there any unacceptable side effects from the therapy?; Question 4: Would you consider using this hydration therapy for this indication in the future?
Time frame: During the infusion (single bolus dose of hylenex [1 hr], followed by subcutaneous fluid for 1 hour to 72 hours)
Population: ITT Population
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Subcutaneous Hylenex | Number of Participants Classified With the Indicated Healthcare Provider Responses to the Questions Comprising the Healthcare Provider Global Satisfaction Questionnaire | Question 1 | Yes | 68 Participants |
| Subcutaneous Hylenex | Number of Participants Classified With the Indicated Healthcare Provider Responses to the Questions Comprising the Healthcare Provider Global Satisfaction Questionnaire | Question 1 | No | 4 Participants |
| Subcutaneous Hylenex | Number of Participants Classified With the Indicated Healthcare Provider Responses to the Questions Comprising the Healthcare Provider Global Satisfaction Questionnaire | Question 1 | Missing | 1 Participants |
| Subcutaneous Hylenex | Number of Participants Classified With the Indicated Healthcare Provider Responses to the Questions Comprising the Healthcare Provider Global Satisfaction Questionnaire | Question 2 | Yes | 69 Participants |
| Subcutaneous Hylenex | Number of Participants Classified With the Indicated Healthcare Provider Responses to the Questions Comprising the Healthcare Provider Global Satisfaction Questionnaire | Question 2 | No | 4 Participants |
| Subcutaneous Hylenex | Number of Participants Classified With the Indicated Healthcare Provider Responses to the Questions Comprising the Healthcare Provider Global Satisfaction Questionnaire | Question 2 | Missing | 0 Participants |
| Subcutaneous Hylenex | Number of Participants Classified With the Indicated Healthcare Provider Responses to the Questions Comprising the Healthcare Provider Global Satisfaction Questionnaire | Question 3 | Yes | 3 Participants |
| Subcutaneous Hylenex | Number of Participants Classified With the Indicated Healthcare Provider Responses to the Questions Comprising the Healthcare Provider Global Satisfaction Questionnaire | Question 3 | No | 70 Participants |
| Subcutaneous Hylenex | Number of Participants Classified With the Indicated Healthcare Provider Responses to the Questions Comprising the Healthcare Provider Global Satisfaction Questionnaire | Question 3 | Missing | 0 Participants |
| Subcutaneous Hylenex | Number of Participants Classified With the Indicated Healthcare Provider Responses to the Questions Comprising the Healthcare Provider Global Satisfaction Questionnaire | Question 4 | Yes | 71 Participants |
| Subcutaneous Hylenex | Number of Participants Classified With the Indicated Healthcare Provider Responses to the Questions Comprising the Healthcare Provider Global Satisfaction Questionnaire | Question 4 | No | 2 Participants |
| Subcutaneous Hylenex | Number of Participants Classified With the Indicated Healthcare Provider Responses to the Questions Comprising the Healthcare Provider Global Satisfaction Questionnaire | Question 4 | Missing | 0 Participants |
| Intravenous Isotonic Fluid | Number of Participants Classified With the Indicated Healthcare Provider Responses to the Questions Comprising the Healthcare Provider Global Satisfaction Questionnaire | Question 4 | No | 6 Participants |
| Intravenous Isotonic Fluid | Number of Participants Classified With the Indicated Healthcare Provider Responses to the Questions Comprising the Healthcare Provider Global Satisfaction Questionnaire | Question 1 | Yes | 57 Participants |
| Intravenous Isotonic Fluid | Number of Participants Classified With the Indicated Healthcare Provider Responses to the Questions Comprising the Healthcare Provider Global Satisfaction Questionnaire | Question 3 | Yes | 4 Participants |
| Intravenous Isotonic Fluid | Number of Participants Classified With the Indicated Healthcare Provider Responses to the Questions Comprising the Healthcare Provider Global Satisfaction Questionnaire | Question 1 | No | 13 Participants |
| Intravenous Isotonic Fluid | Number of Participants Classified With the Indicated Healthcare Provider Responses to the Questions Comprising the Healthcare Provider Global Satisfaction Questionnaire | Question 4 | Yes | 64 Participants |
| Intravenous Isotonic Fluid | Number of Participants Classified With the Indicated Healthcare Provider Responses to the Questions Comprising the Healthcare Provider Global Satisfaction Questionnaire | Question 1 | Missing | 5 Participants |
| Intravenous Isotonic Fluid | Number of Participants Classified With the Indicated Healthcare Provider Responses to the Questions Comprising the Healthcare Provider Global Satisfaction Questionnaire | Question 3 | No | 66 Participants |
| Intravenous Isotonic Fluid | Number of Participants Classified With the Indicated Healthcare Provider Responses to the Questions Comprising the Healthcare Provider Global Satisfaction Questionnaire | Question 2 | Yes | 49 Participants |
| Intravenous Isotonic Fluid | Number of Participants Classified With the Indicated Healthcare Provider Responses to the Questions Comprising the Healthcare Provider Global Satisfaction Questionnaire | Question 4 | Missing | 5 Participants |
| Intravenous Isotonic Fluid | Number of Participants Classified With the Indicated Healthcare Provider Responses to the Questions Comprising the Healthcare Provider Global Satisfaction Questionnaire | Question 2 | No | 21 Participants |
| Intravenous Isotonic Fluid | Number of Participants Classified With the Indicated Healthcare Provider Responses to the Questions Comprising the Healthcare Provider Global Satisfaction Questionnaire | Question 3 | Missing | 5 Participants |
| Intravenous Isotonic Fluid | Number of Participants Classified With the Indicated Healthcare Provider Responses to the Questions Comprising the Healthcare Provider Global Satisfaction Questionnaire | Question 2 | Missing | 5 Participants |
p-value: 0.0685Cochran-Mantel-Haenszel
p-value: 0.0004Cochran-Mantel-Haenszel
p-value: 0.6861Cochran-Mantel-Haenszel
p-value: 0.2323Cochran-Mantel-Haenszel
Secondary
Number of Participants Classified With the Indicated Parent/Guardian Responses to the Questions Comprising the Parent / Guardian Global Satisfaction Questionnaire
A global assessment of overall satisfaction with the rehydration therapy by healthcare provider was performed at the end of SC or IV fluid rehydration utilizing a simple questionnaire. There were separate questionnaires for the two types of rehydration (SC and IV). Question 1: Do you believe the method of therapy was successful in your child's rehydration?; Question 2: Have you or your child ever previously had IV fluids (for SC Group) / SC fluids (for IV Group)?; Question 3: If the response to Question 2 was yes, how does this compare to prior experience with IV (for SC Group) / SC (for IV Group)?; Question 4: Should your child(ren) need rehydration treatment in the future, would you opt for this procedure?; Question 5: Should you need rehydration treatment in the future, would you opt for this procedure?; Question 6: What is your global satisfaction with the study procedure?
Time frame: During the infusion (single bolus dose of hylenex [1 hr], followed by subcutaneous fluid for 1 hour to 72 hours)
Population: ITT Population. Only participants with a response of Yes to Question 2 contributed responses for Question 3.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Subcutaneous Hylenex | Number of Participants Classified With the Indicated Parent/Guardian Responses to the Questions Comprising the Parent / Guardian Global Satisfaction Questionnaire | Question 1, missing | 0 Participants |
| Subcutaneous Hylenex | Number of Participants Classified With the Indicated Parent/Guardian Responses to the Questions Comprising the Parent / Guardian Global Satisfaction Questionnaire | Question 4, not done | 2 Participants |
| Subcutaneous Hylenex | Number of Participants Classified With the Indicated Parent/Guardian Responses to the Questions Comprising the Parent / Guardian Global Satisfaction Questionnaire | Question 3, worse | 2 Participants |
| Subcutaneous Hylenex | Number of Participants Classified With the Indicated Parent/Guardian Responses to the Questions Comprising the Parent / Guardian Global Satisfaction Questionnaire | Question 4, unknown | 1 Participants |
| Subcutaneous Hylenex | Number of Participants Classified With the Indicated Parent/Guardian Responses to the Questions Comprising the Parent / Guardian Global Satisfaction Questionnaire | Question 2, no | 26 Participants |
| Subcutaneous Hylenex | Number of Participants Classified With the Indicated Parent/Guardian Responses to the Questions Comprising the Parent / Guardian Global Satisfaction Questionnaire | Question 4, missing | 1 Participants |
| Subcutaneous Hylenex | Number of Participants Classified With the Indicated Parent/Guardian Responses to the Questions Comprising the Parent / Guardian Global Satisfaction Questionnaire | Question 3, same | 9 Participants |
| Subcutaneous Hylenex | Number of Participants Classified With the Indicated Parent/Guardian Responses to the Questions Comprising the Parent / Guardian Global Satisfaction Questionnaire | Question 5, yes | 68 Participants |
| Subcutaneous Hylenex | Number of Participants Classified With the Indicated Parent/Guardian Responses to the Questions Comprising the Parent / Guardian Global Satisfaction Questionnaire | Question 1, no | 3 Participants |
| Subcutaneous Hylenex | Number of Participants Classified With the Indicated Parent/Guardian Responses to the Questions Comprising the Parent / Guardian Global Satisfaction Questionnaire | Question 5, no | 4 Participants |
| Subcutaneous Hylenex | Number of Participants Classified With the Indicated Parent/Guardian Responses to the Questions Comprising the Parent / Guardian Global Satisfaction Questionnaire | Question 3, better | 35 Participants |
| Subcutaneous Hylenex | Number of Participants Classified With the Indicated Parent/Guardian Responses to the Questions Comprising the Parent / Guardian Global Satisfaction Questionnaire | Question 5, not done | 1 Participants |
| Subcutaneous Hylenex | Number of Participants Classified With the Indicated Parent/Guardian Responses to the Questions Comprising the Parent / Guardian Global Satisfaction Questionnaire | Question 2, not done | 0 Participants |
| Subcutaneous Hylenex | Number of Participants Classified With the Indicated Parent/Guardian Responses to the Questions Comprising the Parent / Guardian Global Satisfaction Questionnaire | Question 5, missing | 0 Participants |
| Subcutaneous Hylenex | Number of Participants Classified With the Indicated Parent/Guardian Responses to the Questions Comprising the Parent / Guardian Global Satisfaction Questionnaire | Question 3, missing | 1 Participants |
| Subcutaneous Hylenex | Number of Participants Classified With the Indicated Parent/Guardian Responses to the Questions Comprising the Parent / Guardian Global Satisfaction Questionnaire | Question 6, very unsatisfied | 3 Participants |
| Subcutaneous Hylenex | Number of Participants Classified With the Indicated Parent/Guardian Responses to the Questions Comprising the Parent / Guardian Global Satisfaction Questionnaire | Question 2, yes | 47 Participants |
| Subcutaneous Hylenex | Number of Participants Classified With the Indicated Parent/Guardian Responses to the Questions Comprising the Parent / Guardian Global Satisfaction Questionnaire | Question 6, unsatisfied | 1 Participants |
| Subcutaneous Hylenex | Number of Participants Classified With the Indicated Parent/Guardian Responses to the Questions Comprising the Parent / Guardian Global Satisfaction Questionnaire | Question 4, yes | 65 Participants |
| Subcutaneous Hylenex | Number of Participants Classified With the Indicated Parent/Guardian Responses to the Questions Comprising the Parent / Guardian Global Satisfaction Questionnaire | Question 6, satisfied | 26 Participants |
| Subcutaneous Hylenex | Number of Participants Classified With the Indicated Parent/Guardian Responses to the Questions Comprising the Parent / Guardian Global Satisfaction Questionnaire | Question 2, missing | 0 Participants |
| Subcutaneous Hylenex | Number of Participants Classified With the Indicated Parent/Guardian Responses to the Questions Comprising the Parent / Guardian Global Satisfaction Questionnaire | Question 6, very satisfied | 43 Participants |
| Subcutaneous Hylenex | Number of Participants Classified With the Indicated Parent/Guardian Responses to the Questions Comprising the Parent / Guardian Global Satisfaction Questionnaire | Question 4, no | 4 Participants |
| Subcutaneous Hylenex | Number of Participants Classified With the Indicated Parent/Guardian Responses to the Questions Comprising the Parent / Guardian Global Satisfaction Questionnaire | Question 6, missing | 0 Participants |
| Subcutaneous Hylenex | Number of Participants Classified With the Indicated Parent/Guardian Responses to the Questions Comprising the Parent / Guardian Global Satisfaction Questionnaire | Question 1, yes | 70 Participants |
| Intravenous Isotonic Fluid | Number of Participants Classified With the Indicated Parent/Guardian Responses to the Questions Comprising the Parent / Guardian Global Satisfaction Questionnaire | Question 6, missing | 8 Participants |
| Intravenous Isotonic Fluid | Number of Participants Classified With the Indicated Parent/Guardian Responses to the Questions Comprising the Parent / Guardian Global Satisfaction Questionnaire | Question 1, yes | 59 Participants |
| Intravenous Isotonic Fluid | Number of Participants Classified With the Indicated Parent/Guardian Responses to the Questions Comprising the Parent / Guardian Global Satisfaction Questionnaire | Question 1, no | 8 Participants |
| Intravenous Isotonic Fluid | Number of Participants Classified With the Indicated Parent/Guardian Responses to the Questions Comprising the Parent / Guardian Global Satisfaction Questionnaire | Question 1, missing | 8 Participants |
| Intravenous Isotonic Fluid | Number of Participants Classified With the Indicated Parent/Guardian Responses to the Questions Comprising the Parent / Guardian Global Satisfaction Questionnaire | Question 2, yes | 2 Participants |
| Intravenous Isotonic Fluid | Number of Participants Classified With the Indicated Parent/Guardian Responses to the Questions Comprising the Parent / Guardian Global Satisfaction Questionnaire | Question 2, no | 63 Participants |
| Intravenous Isotonic Fluid | Number of Participants Classified With the Indicated Parent/Guardian Responses to the Questions Comprising the Parent / Guardian Global Satisfaction Questionnaire | Question 2, not done | 2 Participants |
| Intravenous Isotonic Fluid | Number of Participants Classified With the Indicated Parent/Guardian Responses to the Questions Comprising the Parent / Guardian Global Satisfaction Questionnaire | Question 2, missing | 8 Participants |
| Intravenous Isotonic Fluid | Number of Participants Classified With the Indicated Parent/Guardian Responses to the Questions Comprising the Parent / Guardian Global Satisfaction Questionnaire | Question 3, worse | 0 Participants |
| Intravenous Isotonic Fluid | Number of Participants Classified With the Indicated Parent/Guardian Responses to the Questions Comprising the Parent / Guardian Global Satisfaction Questionnaire | Question 3, same | 2 Participants |
| Intravenous Isotonic Fluid | Number of Participants Classified With the Indicated Parent/Guardian Responses to the Questions Comprising the Parent / Guardian Global Satisfaction Questionnaire | Question 3, better | 0 Participants |
| Intravenous Isotonic Fluid | Number of Participants Classified With the Indicated Parent/Guardian Responses to the Questions Comprising the Parent / Guardian Global Satisfaction Questionnaire | Question 3, missing | 0 Participants |
| Intravenous Isotonic Fluid | Number of Participants Classified With the Indicated Parent/Guardian Responses to the Questions Comprising the Parent / Guardian Global Satisfaction Questionnaire | Question 4, yes | 56 Participants |
| Intravenous Isotonic Fluid | Number of Participants Classified With the Indicated Parent/Guardian Responses to the Questions Comprising the Parent / Guardian Global Satisfaction Questionnaire | Question 4, no | 11 Participants |
| Intravenous Isotonic Fluid | Number of Participants Classified With the Indicated Parent/Guardian Responses to the Questions Comprising the Parent / Guardian Global Satisfaction Questionnaire | Question 4, not done | 0 Participants |
| Intravenous Isotonic Fluid | Number of Participants Classified With the Indicated Parent/Guardian Responses to the Questions Comprising the Parent / Guardian Global Satisfaction Questionnaire | Question 4, unknown | 0 Participants |
| Intravenous Isotonic Fluid | Number of Participants Classified With the Indicated Parent/Guardian Responses to the Questions Comprising the Parent / Guardian Global Satisfaction Questionnaire | Question 4, missing | 8 Participants |
| Intravenous Isotonic Fluid | Number of Participants Classified With the Indicated Parent/Guardian Responses to the Questions Comprising the Parent / Guardian Global Satisfaction Questionnaire | Question 5, yes | 55 Participants |
| Intravenous Isotonic Fluid | Number of Participants Classified With the Indicated Parent/Guardian Responses to the Questions Comprising the Parent / Guardian Global Satisfaction Questionnaire | Question 5, no | 12 Participants |
| Intravenous Isotonic Fluid | Number of Participants Classified With the Indicated Parent/Guardian Responses to the Questions Comprising the Parent / Guardian Global Satisfaction Questionnaire | Question 5, not done | 0 Participants |
| Intravenous Isotonic Fluid | Number of Participants Classified With the Indicated Parent/Guardian Responses to the Questions Comprising the Parent / Guardian Global Satisfaction Questionnaire | Question 5, missing | 8 Participants |
| Intravenous Isotonic Fluid | Number of Participants Classified With the Indicated Parent/Guardian Responses to the Questions Comprising the Parent / Guardian Global Satisfaction Questionnaire | Question 6, very unsatisfied | 8 Participants |
| Intravenous Isotonic Fluid | Number of Participants Classified With the Indicated Parent/Guardian Responses to the Questions Comprising the Parent / Guardian Global Satisfaction Questionnaire | Question 6, unsatisfied | 4 Participants |
| Intravenous Isotonic Fluid | Number of Participants Classified With the Indicated Parent/Guardian Responses to the Questions Comprising the Parent / Guardian Global Satisfaction Questionnaire | Question 6, satisfied | 31 Participants |
| Intravenous Isotonic Fluid | Number of Participants Classified With the Indicated Parent/Guardian Responses to the Questions Comprising the Parent / Guardian Global Satisfaction Questionnaire | Question 6, very satisfied | 24 Participants |
p-value: 0.0852Cochran-Mantel-Haenszel
p-value: 0.0275Cochran-Mantel-Haenszel
p-value: 0.2012Cochran-Mantel-Haenszel
p-value: <0.0001Cochran-Mantel-Haenszel
p-value: 0.1302Cochran-Mantel-Haenszel
Secondary
Number of Participants Discharged From the ED to Home or the Hospital
Participants were discharged from the ED to home or the hospital to continue hydration therapy.
Time frame: up to approximately 26 hours
Population: ITT Population. Only those participants for which fluid administration was initiated were analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Subcutaneous Hylenex | Number of Participants Discharged From the ED to Home or the Hospital | Home | 60 Participants |
| Subcutaneous Hylenex | Number of Participants Discharged From the ED to Home or the Hospital | Hospital | 13 Participants |
| Intravenous Isotonic Fluid | Number of Participants Discharged From the ED to Home or the Hospital | Home | 64 Participants |
| Intravenous Isotonic Fluid | Number of Participants Discharged From the ED to Home or the Hospital | Hospital | 10 Participants |
Secondary
Number of Participants Experiencing Reductions in Flow Rate
In the event that the degree of local infusion site swelling became unacceptable for any reason (e.g., a 30% or greater increase from the baseline circumference of the infused thigh or in the clinical judgment of the investigator), the infusion rate was decreased or the infusion site was changed.
Time frame: During the infusion (single bolus dose of hylenex [1 hr], followed by subcutaneous fluid for 1 hour to 72 hours)
Population: ITT Population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Subcutaneous Hylenex | Number of Participants Experiencing Reductions in Flow Rate | 43 Participants |
| Intravenous Isotonic Fluid | Number of Participants Experiencing Reductions in Flow Rate | 39 Participants |
Secondary
Number of Participants for Which the Indicated Gauge for Infusion Device Was Used
Data are reported for the gauge of infusion device used.
Time frame: average of approximately 3 minutes
Population: ITT Population. Only those participants for which fluid administration was initiated were analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Subcutaneous Hylenex | Number of Participants for Which the Indicated Gauge for Infusion Device Was Used | 26 | 0 Participants |
| Subcutaneous Hylenex | Number of Participants for Which the Indicated Gauge for Infusion Device Was Used | 23 | 4 Participants |
| Subcutaneous Hylenex | Number of Participants for Which the Indicated Gauge for Infusion Device Was Used | 25 | 8 Participants |
| Subcutaneous Hylenex | Number of Participants for Which the Indicated Gauge for Infusion Device Was Used | 20 | 2 Participants |
| Subcutaneous Hylenex | Number of Participants for Which the Indicated Gauge for Infusion Device Was Used | 24 | 31 Participants |
| Subcutaneous Hylenex | Number of Participants for Which the Indicated Gauge for Infusion Device Was Used | 22 | 28 Participants |
| Intravenous Isotonic Fluid | Number of Participants for Which the Indicated Gauge for Infusion Device Was Used | 24 | 33 Participants |
| Intravenous Isotonic Fluid | Number of Participants for Which the Indicated Gauge for Infusion Device Was Used | 25 | 2 Participants |
| Intravenous Isotonic Fluid | Number of Participants for Which the Indicated Gauge for Infusion Device Was Used | 22 | 22 Participants |
| Intravenous Isotonic Fluid | Number of Participants for Which the Indicated Gauge for Infusion Device Was Used | 26 | 1 Participants |
| Intravenous Isotonic Fluid | Number of Participants for Which the Indicated Gauge for Infusion Device Was Used | 20 | 0 Participants |
| Intravenous Isotonic Fluid | Number of Participants for Which the Indicated Gauge for Infusion Device Was Used | 23 | 1 Participants |
| Intravenous Isotonic Fluid: SC Rescued | Number of Participants for Which the Indicated Gauge for Infusion Device Was Used | 26 | 0 Participants |
| Intravenous Isotonic Fluid: SC Rescued | Number of Participants for Which the Indicated Gauge for Infusion Device Was Used | 20 | 0 Participants |
| Intravenous Isotonic Fluid: SC Rescued | Number of Participants for Which the Indicated Gauge for Infusion Device Was Used | 22 | 5 Participants |
| Intravenous Isotonic Fluid: SC Rescued | Number of Participants for Which the Indicated Gauge for Infusion Device Was Used | 23 | 0 Participants |
| Intravenous Isotonic Fluid: SC Rescued | Number of Participants for Which the Indicated Gauge for Infusion Device Was Used | 24 | 10 Participants |
| Intravenous Isotonic Fluid: SC Rescued | Number of Participants for Which the Indicated Gauge for Infusion Device Was Used | 25 | 0 Participants |
Secondary
Number of Participants for Which the Indicated Number of Additional Personnel Was Involved in Needle Placement
Data were collected for the number of additional personnel involved in needle placement.
Time frame: average of approximately 3 minutes
Population: ITT Population. Only those participants for which fluid administration was initiated were analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Subcutaneous Hylenex | Number of Participants for Which the Indicated Number of Additional Personnel Was Involved in Needle Placement | 3 | 3 Participants |
| Subcutaneous Hylenex | Number of Participants for Which the Indicated Number of Additional Personnel Was Involved in Needle Placement | 2 | 14 Participants |
| Subcutaneous Hylenex | Number of Participants for Which the Indicated Number of Additional Personnel Was Involved in Needle Placement | 0 | 20 Participants |
| Subcutaneous Hylenex | Number of Participants for Which the Indicated Number of Additional Personnel Was Involved in Needle Placement | 1 | 36 Participants |
| Subcutaneous Hylenex | Number of Participants for Which the Indicated Number of Additional Personnel Was Involved in Needle Placement | 4 | 0 Participants |
| Intravenous Isotonic Fluid | Number of Participants for Which the Indicated Number of Additional Personnel Was Involved in Needle Placement | 2 | 20 Participants |
| Intravenous Isotonic Fluid | Number of Participants for Which the Indicated Number of Additional Personnel Was Involved in Needle Placement | 0 | 1 Participants |
| Intravenous Isotonic Fluid | Number of Participants for Which the Indicated Number of Additional Personnel Was Involved in Needle Placement | 1 | 34 Participants |
| Intravenous Isotonic Fluid | Number of Participants for Which the Indicated Number of Additional Personnel Was Involved in Needle Placement | 3 | 3 Participants |
| Intravenous Isotonic Fluid | Number of Participants for Which the Indicated Number of Additional Personnel Was Involved in Needle Placement | 4 | 1 Participants |
| Intravenous Isotonic Fluid: SC Rescued | Number of Participants for Which the Indicated Number of Additional Personnel Was Involved in Needle Placement | 4 | 0 Participants |
| Intravenous Isotonic Fluid: SC Rescued | Number of Participants for Which the Indicated Number of Additional Personnel Was Involved in Needle Placement | 3 | 2 Participants |
| Intravenous Isotonic Fluid: SC Rescued | Number of Participants for Which the Indicated Number of Additional Personnel Was Involved in Needle Placement | 0 | 1 Participants |
| Intravenous Isotonic Fluid: SC Rescued | Number of Participants for Which the Indicated Number of Additional Personnel Was Involved in Needle Placement | 2 | 7 Participants |
| Intravenous Isotonic Fluid: SC Rescued | Number of Participants for Which the Indicated Number of Additional Personnel Was Involved in Needle Placement | 1 | 5 Participants |
Secondary
Number of Participants for Which the Indicated Type of Infusion Device Was Used
Data are reported for the type of infusion device used.
Time frame: average of approximately 3 minutes
Population: ITT Population. Only those participants for which fluid administration was initiated were analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Subcutaneous Hylenex | Number of Participants for Which the Indicated Type of Infusion Device Was Used | Butterfly needle | 10 Participants |
| Subcutaneous Hylenex | Number of Participants for Which the Indicated Type of Infusion Device Was Used | Angiocatheter | 63 Participants |
| Subcutaneous Hylenex | Number of Participants for Which the Indicated Type of Infusion Device Was Used | Other | 0 Participants |
| Intravenous Isotonic Fluid | Number of Participants for Which the Indicated Type of Infusion Device Was Used | Butterfly needle | 1 Participants |
| Intravenous Isotonic Fluid | Number of Participants for Which the Indicated Type of Infusion Device Was Used | Angiocatheter | 57 Participants |
| Intravenous Isotonic Fluid | Number of Participants for Which the Indicated Type of Infusion Device Was Used | Other | 1 Participants |
| Intravenous Isotonic Fluid: SC Rescued | Number of Participants for Which the Indicated Type of Infusion Device Was Used | Angiocatheter | 15 Participants |
| Intravenous Isotonic Fluid: SC Rescued | Number of Participants for Which the Indicated Type of Infusion Device Was Used | Other | 0 Participants |
| Intravenous Isotonic Fluid: SC Rescued | Number of Participants for Which the Indicated Type of Infusion Device Was Used | Butterfly needle | 0 Participants |
Secondary
Number of Participants Who Received Needle Placement by People With the Indicated Level of Staff Training
Data were collected for the level of staff training for the person who performed the needle placement.
Time frame: average of approximately 3 minutes
Population: ITT Population. Only those participants for which fluid administration was initiated were analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Subcutaneous Hylenex | Number of Participants Who Received Needle Placement by People With the Indicated Level of Staff Training | Licensed vocational nurse | 0 Participants |
| Subcutaneous Hylenex | Number of Participants Who Received Needle Placement by People With the Indicated Level of Staff Training | Physician assistant | 2 Participants |
| Subcutaneous Hylenex | Number of Participants Who Received Needle Placement by People With the Indicated Level of Staff Training | Nurse practitioner | 6 Participants |
| Subcutaneous Hylenex | Number of Participants Who Received Needle Placement by People With the Indicated Level of Staff Training | Other | 2 Participants |
| Subcutaneous Hylenex | Number of Participants Who Received Needle Placement by People With the Indicated Level of Staff Training | Registered nurse | 35 Participants |
| Subcutaneous Hylenex | Number of Participants Who Received Needle Placement by People With the Indicated Level of Staff Training | Physician | 28 Participants |
| Intravenous Isotonic Fluid | Number of Participants Who Received Needle Placement by People With the Indicated Level of Staff Training | Physician assistant | 2 Participants |
| Intravenous Isotonic Fluid | Number of Participants Who Received Needle Placement by People With the Indicated Level of Staff Training | Physician | 4 Participants |
| Intravenous Isotonic Fluid | Number of Participants Who Received Needle Placement by People With the Indicated Level of Staff Training | Registered nurse | 48 Participants |
| Intravenous Isotonic Fluid | Number of Participants Who Received Needle Placement by People With the Indicated Level of Staff Training | Nurse practitioner | 0 Participants |
| Intravenous Isotonic Fluid | Number of Participants Who Received Needle Placement by People With the Indicated Level of Staff Training | Licensed vocational nurse | 0 Participants |
| Intravenous Isotonic Fluid | Number of Participants Who Received Needle Placement by People With the Indicated Level of Staff Training | Other | 5 Participants |
| Intravenous Isotonic Fluid: SC Rescued | Number of Participants Who Received Needle Placement by People With the Indicated Level of Staff Training | Registered nurse | 10 Participants |
| Intravenous Isotonic Fluid: SC Rescued | Number of Participants Who Received Needle Placement by People With the Indicated Level of Staff Training | Other | 1 Participants |
| Intravenous Isotonic Fluid: SC Rescued | Number of Participants Who Received Needle Placement by People With the Indicated Level of Staff Training | Licensed vocational nurse | 2 Participants |
| Intravenous Isotonic Fluid: SC Rescued | Number of Participants Who Received Needle Placement by People With the Indicated Level of Staff Training | Physician assistant | 1 Participants |
| Intravenous Isotonic Fluid: SC Rescued | Number of Participants Who Received Needle Placement by People With the Indicated Level of Staff Training | Physician | 1 Participants |
| Intravenous Isotonic Fluid: SC Rescued | Number of Participants Who Received Needle Placement by People With the Indicated Level of Staff Training | Nurse practitioner | 0 Participants |
Secondary
Number of Participants With Normal Physical Examination Findings at Baseline That Shifted to Abnormal at the End of Fluid Administration
Baseline was defined as the time prior to the single site fluid infusion. End of infusion was defined as the end of infusion of the single site fluid infusion for participants who had more than one fluid infusion. Not Rel Dehy = Abnormal, Not Related to Dehydration; Rel Dehy = Abnormal, Related to Dehydration. The investigator assessed findings as abnormal.
Time frame: Baseline; after infusion (single bolus dose of hylenex [1 hr], followed by subcutaneous fluid for 1 hour to 72 hours)
Population: Safety Population. Only those participants for which fluid administration was initiated were analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Subcutaneous Hylenex | Number of Participants With Normal Physical Examination Findings at Baseline That Shifted to Abnormal at the End of Fluid Administration | Abdomen: Rel Dehy | 0 Participants |
| Subcutaneous Hylenex | Number of Participants With Normal Physical Examination Findings at Baseline That Shifted to Abnormal at the End of Fluid Administration | Endocrine/Metabolism and Nutrition: Not Rel Dehy | 0 Participants |
| Subcutaneous Hylenex | Number of Participants With Normal Physical Examination Findings at Baseline That Shifted to Abnormal at the End of Fluid Administration | Vascular/Circulatory: Not Rel Dehy | 0 Participants |
| Subcutaneous Hylenex | Number of Participants With Normal Physical Examination Findings at Baseline That Shifted to Abnormal at the End of Fluid Administration | Skin: Not Rel Dehy | 0 Participants |
| Subcutaneous Hylenex | Number of Participants With Normal Physical Examination Findings at Baseline That Shifted to Abnormal at the End of Fluid Administration | Neck/upper airway: Not Rel Dehy | 0 Participants |
| Subcutaneous Hylenex | Number of Participants With Normal Physical Examination Findings at Baseline That Shifted to Abnormal at the End of Fluid Administration | Neurological: Not Rel Dehy | 1 Participants |
| Subcutaneous Hylenex | Number of Participants With Normal Physical Examination Findings at Baseline That Shifted to Abnormal at the End of Fluid Administration | Skin: Rel Dehy | 0 Participants |
| Subcutaneous Hylenex | Number of Participants With Normal Physical Examination Findings at Baseline That Shifted to Abnormal at the End of Fluid Administration | Renal/Urinary: Rel Dehy | 1 Participants |
| Subcutaneous Hylenex | Number of Participants With Normal Physical Examination Findings at Baseline That Shifted to Abnormal at the End of Fluid Administration | Extremities: Rel Dehy | 0 Participants |
| Subcutaneous Hylenex | Number of Participants With Normal Physical Examination Findings at Baseline That Shifted to Abnormal at the End of Fluid Administration | Musculoskeletal: Not Rel Dehy | 0 Participants |
| Subcutaneous Hylenex | Number of Participants With Normal Physical Examination Findings at Baseline That Shifted to Abnormal at the End of Fluid Administration | Neck/upper airway: Rel Dehy | 0 Participants |
| Subcutaneous Hylenex | Number of Participants With Normal Physical Examination Findings at Baseline That Shifted to Abnormal at the End of Fluid Administration | Extremities: Not Rel Dehy | 0 Participants |
| Subcutaneous Hylenex | Number of Participants With Normal Physical Examination Findings at Baseline That Shifted to Abnormal at the End of Fluid Administration | Musculoskeletal: Rel Dehy | 0 Participants |
| Subcutaneous Hylenex | Number of Participants With Normal Physical Examination Findings at Baseline That Shifted to Abnormal at the End of Fluid Administration | Other: Not Rel Dehy | 0 Participants |
| Subcutaneous Hylenex | Number of Participants With Normal Physical Examination Findings at Baseline That Shifted to Abnormal at the End of Fluid Administration | Renal/Urinary: Not Rel Dehy | 0 Participants |
| Subcutaneous Hylenex | Number of Participants With Normal Physical Examination Findings at Baseline That Shifted to Abnormal at the End of Fluid Administration | Heart: Not Rel Dehy | 0 Participants |
| Subcutaneous Hylenex | Number of Participants With Normal Physical Examination Findings at Baseline That Shifted to Abnormal at the End of Fluid Administration | Head, eyes, ears: Not Rel Dehy | 1 Participants |
| Subcutaneous Hylenex | Number of Participants With Normal Physical Examination Findings at Baseline That Shifted to Abnormal at the End of Fluid Administration | Reproductive: Rel Dehy | 0 Participants |
| Subcutaneous Hylenex | Number of Participants With Normal Physical Examination Findings at Baseline That Shifted to Abnormal at the End of Fluid Administration | Heart: Rel Dehy | 0 Participants |
| Subcutaneous Hylenex | Number of Participants With Normal Physical Examination Findings at Baseline That Shifted to Abnormal at the End of Fluid Administration | Other: Rel Dehy | 0 Participants |
| Subcutaneous Hylenex | Number of Participants With Normal Physical Examination Findings at Baseline That Shifted to Abnormal at the End of Fluid Administration | Reproductive: Not Rel Dehy | 0 Participants |
| Subcutaneous Hylenex | Number of Participants With Normal Physical Examination Findings at Baseline That Shifted to Abnormal at the End of Fluid Administration | Lungs: Not Rel Dehy | 0 Participants |
| Subcutaneous Hylenex | Number of Participants With Normal Physical Examination Findings at Baseline That Shifted to Abnormal at the End of Fluid Administration | Endocrine/Metabolism and Nutrition: Rel Dehy | 0 Participants |
| Subcutaneous Hylenex | Number of Participants With Normal Physical Examination Findings at Baseline That Shifted to Abnormal at the End of Fluid Administration | Lymphatic: Rel Dehy | 0 Participants |
| Subcutaneous Hylenex | Number of Participants With Normal Physical Examination Findings at Baseline That Shifted to Abnormal at the End of Fluid Administration | Lungs: Rel Dehy | 0 Participants |
| Subcutaneous Hylenex | Number of Participants With Normal Physical Examination Findings at Baseline That Shifted to Abnormal at the End of Fluid Administration | Head, eyes, ears: Rel Dehy | 0 Participants |
| Subcutaneous Hylenex | Number of Participants With Normal Physical Examination Findings at Baseline That Shifted to Abnormal at the End of Fluid Administration | Lymphatic: Not Rel Dehy | 0 Participants |
| Subcutaneous Hylenex | Number of Participants With Normal Physical Examination Findings at Baseline That Shifted to Abnormal at the End of Fluid Administration | Abdomen: Not Rel Dehy | 0 Participants |
| Subcutaneous Hylenex | Number of Participants With Normal Physical Examination Findings at Baseline That Shifted to Abnormal at the End of Fluid Administration | Neurological: Rel Dehy | 0 Participants |
| Subcutaneous Hylenex | Number of Participants With Normal Physical Examination Findings at Baseline That Shifted to Abnormal at the End of Fluid Administration | Vascular/Circulatory: Rel Dehy | 1 Participants |
| Intravenous Isotonic Fluid | Number of Participants With Normal Physical Examination Findings at Baseline That Shifted to Abnormal at the End of Fluid Administration | Vascular/Circulatory: Not Rel Dehy | 0 Participants |
| Intravenous Isotonic Fluid | Number of Participants With Normal Physical Examination Findings at Baseline That Shifted to Abnormal at the End of Fluid Administration | Head, eyes, ears: Not Rel Dehy | 0 Participants |
| Intravenous Isotonic Fluid | Number of Participants With Normal Physical Examination Findings at Baseline That Shifted to Abnormal at the End of Fluid Administration | Head, eyes, ears: Rel Dehy | 0 Participants |
| Intravenous Isotonic Fluid | Number of Participants With Normal Physical Examination Findings at Baseline That Shifted to Abnormal at the End of Fluid Administration | Neck/upper airway: Rel Dehy | 0 Participants |
| Intravenous Isotonic Fluid | Number of Participants With Normal Physical Examination Findings at Baseline That Shifted to Abnormal at the End of Fluid Administration | Heart: Not Rel Dehy | 1 Participants |
| Intravenous Isotonic Fluid | Number of Participants With Normal Physical Examination Findings at Baseline That Shifted to Abnormal at the End of Fluid Administration | Heart: Rel Dehy | 0 Participants |
| Intravenous Isotonic Fluid | Number of Participants With Normal Physical Examination Findings at Baseline That Shifted to Abnormal at the End of Fluid Administration | Lungs: Not Rel Dehy | 0 Participants |
| Intravenous Isotonic Fluid | Number of Participants With Normal Physical Examination Findings at Baseline That Shifted to Abnormal at the End of Fluid Administration | Lungs: Rel Dehy | 0 Participants |
| Intravenous Isotonic Fluid | Number of Participants With Normal Physical Examination Findings at Baseline That Shifted to Abnormal at the End of Fluid Administration | Abdomen: Not Rel Dehy | 0 Participants |
| Intravenous Isotonic Fluid | Number of Participants With Normal Physical Examination Findings at Baseline That Shifted to Abnormal at the End of Fluid Administration | Abdomen: Rel Dehy | 0 Participants |
| Intravenous Isotonic Fluid | Number of Participants With Normal Physical Examination Findings at Baseline That Shifted to Abnormal at the End of Fluid Administration | Skin: Not Rel Dehy | 1 Participants |
| Intravenous Isotonic Fluid | Number of Participants With Normal Physical Examination Findings at Baseline That Shifted to Abnormal at the End of Fluid Administration | Skin: Rel Dehy | 0 Participants |
| Intravenous Isotonic Fluid | Number of Participants With Normal Physical Examination Findings at Baseline That Shifted to Abnormal at the End of Fluid Administration | Musculoskeletal: Not Rel Dehy | 0 Participants |
| Intravenous Isotonic Fluid | Number of Participants With Normal Physical Examination Findings at Baseline That Shifted to Abnormal at the End of Fluid Administration | Musculoskeletal: Rel Dehy | 0 Participants |
| Intravenous Isotonic Fluid | Number of Participants With Normal Physical Examination Findings at Baseline That Shifted to Abnormal at the End of Fluid Administration | Extremities: Not Rel Dehy | 0 Participants |
| Intravenous Isotonic Fluid | Number of Participants With Normal Physical Examination Findings at Baseline That Shifted to Abnormal at the End of Fluid Administration | Extremities: Rel Dehy | 0 Participants |
| Intravenous Isotonic Fluid | Number of Participants With Normal Physical Examination Findings at Baseline That Shifted to Abnormal at the End of Fluid Administration | Neurological: Not Rel Dehy | 0 Participants |
| Intravenous Isotonic Fluid | Number of Participants With Normal Physical Examination Findings at Baseline That Shifted to Abnormal at the End of Fluid Administration | Neurological: Rel Dehy | 0 Participants |
| Intravenous Isotonic Fluid | Number of Participants With Normal Physical Examination Findings at Baseline That Shifted to Abnormal at the End of Fluid Administration | Neck/upper airway: Not Rel Dehy | 0 Participants |
| Intravenous Isotonic Fluid | Number of Participants With Normal Physical Examination Findings at Baseline That Shifted to Abnormal at the End of Fluid Administration | Vascular/Circulatory: Rel Dehy | 0 Participants |
| Intravenous Isotonic Fluid | Number of Participants With Normal Physical Examination Findings at Baseline That Shifted to Abnormal at the End of Fluid Administration | Lymphatic: Not Rel Dehy | 0 Participants |
| Intravenous Isotonic Fluid | Number of Participants With Normal Physical Examination Findings at Baseline That Shifted to Abnormal at the End of Fluid Administration | Lymphatic: Rel Dehy | 0 Participants |
| Intravenous Isotonic Fluid | Number of Participants With Normal Physical Examination Findings at Baseline That Shifted to Abnormal at the End of Fluid Administration | Reproductive: Not Rel Dehy | 0 Participants |
| Intravenous Isotonic Fluid | Number of Participants With Normal Physical Examination Findings at Baseline That Shifted to Abnormal at the End of Fluid Administration | Reproductive: Rel Dehy | 0 Participants |
| Intravenous Isotonic Fluid | Number of Participants With Normal Physical Examination Findings at Baseline That Shifted to Abnormal at the End of Fluid Administration | Renal/Urinary: Not Rel Dehy | 0 Participants |
| Intravenous Isotonic Fluid | Number of Participants With Normal Physical Examination Findings at Baseline That Shifted to Abnormal at the End of Fluid Administration | Renal/Urinary: Rel Dehy | 0 Participants |
| Intravenous Isotonic Fluid | Number of Participants With Normal Physical Examination Findings at Baseline That Shifted to Abnormal at the End of Fluid Administration | Endocrine/Metabolism and Nutrition: Not Rel Dehy | 0 Participants |
| Intravenous Isotonic Fluid | Number of Participants With Normal Physical Examination Findings at Baseline That Shifted to Abnormal at the End of Fluid Administration | Endocrine/Metabolism and Nutrition: Rel Dehy | 0 Participants |
| Intravenous Isotonic Fluid | Number of Participants With Normal Physical Examination Findings at Baseline That Shifted to Abnormal at the End of Fluid Administration | Other: Not Rel Dehy | 0 Participants |
| Intravenous Isotonic Fluid | Number of Participants With Normal Physical Examination Findings at Baseline That Shifted to Abnormal at the End of Fluid Administration | Other: Rel Dehy | 0 Participants |
| Intravenous Isotonic Fluid: SC Rescued | Number of Participants With Normal Physical Examination Findings at Baseline That Shifted to Abnormal at the End of Fluid Administration | Vascular/Circulatory: Rel Dehy | 0 Participants |
| Intravenous Isotonic Fluid: SC Rescued | Number of Participants With Normal Physical Examination Findings at Baseline That Shifted to Abnormal at the End of Fluid Administration | Lungs: Rel Dehy | 0 Participants |
| Intravenous Isotonic Fluid: SC Rescued | Number of Participants With Normal Physical Examination Findings at Baseline That Shifted to Abnormal at the End of Fluid Administration | Endocrine/Metabolism and Nutrition: Not Rel Dehy | 0 Participants |
| Intravenous Isotonic Fluid: SC Rescued | Number of Participants With Normal Physical Examination Findings at Baseline That Shifted to Abnormal at the End of Fluid Administration | Lymphatic: Not Rel Dehy | 0 Participants |
| Intravenous Isotonic Fluid: SC Rescued | Number of Participants With Normal Physical Examination Findings at Baseline That Shifted to Abnormal at the End of Fluid Administration | Lungs: Not Rel Dehy | 0 Participants |
| Intravenous Isotonic Fluid: SC Rescued | Number of Participants With Normal Physical Examination Findings at Baseline That Shifted to Abnormal at the End of Fluid Administration | Head, eyes, ears: Not Rel Dehy | 0 Participants |
| Intravenous Isotonic Fluid: SC Rescued | Number of Participants With Normal Physical Examination Findings at Baseline That Shifted to Abnormal at the End of Fluid Administration | Lymphatic: Rel Dehy | 0 Participants |
| Intravenous Isotonic Fluid: SC Rescued | Number of Participants With Normal Physical Examination Findings at Baseline That Shifted to Abnormal at the End of Fluid Administration | Heart: Rel Dehy | 0 Participants |
| Intravenous Isotonic Fluid: SC Rescued | Number of Participants With Normal Physical Examination Findings at Baseline That Shifted to Abnormal at the End of Fluid Administration | Neurological: Not Rel Dehy | 0 Participants |
| Intravenous Isotonic Fluid: SC Rescued | Number of Participants With Normal Physical Examination Findings at Baseline That Shifted to Abnormal at the End of Fluid Administration | Heart: Not Rel Dehy | 0 Participants |
| Intravenous Isotonic Fluid: SC Rescued | Number of Participants With Normal Physical Examination Findings at Baseline That Shifted to Abnormal at the End of Fluid Administration | Endocrine/Metabolism and Nutrition: Rel Dehy | 0 Participants |
| Intravenous Isotonic Fluid: SC Rescued | Number of Participants With Normal Physical Examination Findings at Baseline That Shifted to Abnormal at the End of Fluid Administration | Reproductive: Rel Dehy | 0 Participants |
| Intravenous Isotonic Fluid: SC Rescued | Number of Participants With Normal Physical Examination Findings at Baseline That Shifted to Abnormal at the End of Fluid Administration | Neck/upper airway: Rel Dehy | 0 Participants |
| Intravenous Isotonic Fluid: SC Rescued | Number of Participants With Normal Physical Examination Findings at Baseline That Shifted to Abnormal at the End of Fluid Administration | Reproductive: Not Rel Dehy | 0 Participants |
| Intravenous Isotonic Fluid: SC Rescued | Number of Participants With Normal Physical Examination Findings at Baseline That Shifted to Abnormal at the End of Fluid Administration | Musculoskeletal: Rel Dehy | 0 Participants |
| Intravenous Isotonic Fluid: SC Rescued | Number of Participants With Normal Physical Examination Findings at Baseline That Shifted to Abnormal at the End of Fluid Administration | Musculoskeletal: Not Rel Dehy | 0 Participants |
| Intravenous Isotonic Fluid: SC Rescued | Number of Participants With Normal Physical Examination Findings at Baseline That Shifted to Abnormal at the End of Fluid Administration | Renal/Urinary: Not Rel Dehy | 0 Participants |
| Intravenous Isotonic Fluid: SC Rescued | Number of Participants With Normal Physical Examination Findings at Baseline That Shifted to Abnormal at the End of Fluid Administration | Extremities: Not Rel Dehy | 0 Participants |
| Intravenous Isotonic Fluid: SC Rescued | Number of Participants With Normal Physical Examination Findings at Baseline That Shifted to Abnormal at the End of Fluid Administration | Skin: Rel Dehy | 0 Participants |
| Intravenous Isotonic Fluid: SC Rescued | Number of Participants With Normal Physical Examination Findings at Baseline That Shifted to Abnormal at the End of Fluid Administration | Neck/upper airway: Not Rel Dehy | 0 Participants |
| Intravenous Isotonic Fluid: SC Rescued | Number of Participants With Normal Physical Examination Findings at Baseline That Shifted to Abnormal at the End of Fluid Administration | Extremities: Rel Dehy | 0 Participants |
| Intravenous Isotonic Fluid: SC Rescued | Number of Participants With Normal Physical Examination Findings at Baseline That Shifted to Abnormal at the End of Fluid Administration | Skin: Not Rel Dehy | 2 Participants |
| Intravenous Isotonic Fluid: SC Rescued | Number of Participants With Normal Physical Examination Findings at Baseline That Shifted to Abnormal at the End of Fluid Administration | Other: Rel Dehy | 0 Participants |
| Intravenous Isotonic Fluid: SC Rescued | Number of Participants With Normal Physical Examination Findings at Baseline That Shifted to Abnormal at the End of Fluid Administration | Renal/Urinary: Rel Dehy | 0 Participants |
| Intravenous Isotonic Fluid: SC Rescued | Number of Participants With Normal Physical Examination Findings at Baseline That Shifted to Abnormal at the End of Fluid Administration | Neurological: Rel Dehy | 0 Participants |
| Intravenous Isotonic Fluid: SC Rescued | Number of Participants With Normal Physical Examination Findings at Baseline That Shifted to Abnormal at the End of Fluid Administration | Abdomen: Rel Dehy | 0 Participants |
| Intravenous Isotonic Fluid: SC Rescued | Number of Participants With Normal Physical Examination Findings at Baseline That Shifted to Abnormal at the End of Fluid Administration | Head, eyes, ears: Rel Dehy | 0 Participants |
| Intravenous Isotonic Fluid: SC Rescued | Number of Participants With Normal Physical Examination Findings at Baseline That Shifted to Abnormal at the End of Fluid Administration | Vascular/Circulatory: Not Rel Dehy | 0 Participants |
| Intravenous Isotonic Fluid: SC Rescued | Number of Participants With Normal Physical Examination Findings at Baseline That Shifted to Abnormal at the End of Fluid Administration | Abdomen: Not Rel Dehy | 0 Participants |
| Intravenous Isotonic Fluid: SC Rescued | Number of Participants With Normal Physical Examination Findings at Baseline That Shifted to Abnormal at the End of Fluid Administration | Other: Not Rel Dehy | 0 Participants |
Secondary
Number of Participants With the Indicated Number of Different Anatomical Administration Sites Needed After the Start of Fluid Administration
In the event that the degree of local infusion site swelling became unacceptable for any reason (e.g., a 30% or greater increase from the baseline circumference of the infused thigh or in the clinical judgment of the investigator), the infusion rate was decreased or the infusion site was changed.
Time frame: During the infusion (single bolus dose of hylenex [1 hr], followed by subcutaneous fluid for 1 hour to 72 hours)
Population: ITT Population. Only those participants for which fluid administration was initiated were analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Subcutaneous Hylenex | Number of Participants With the Indicated Number of Different Anatomical Administration Sites Needed After the Start of Fluid Administration | 1 administration site | 72 Participants |
| Subcutaneous Hylenex | Number of Participants With the Indicated Number of Different Anatomical Administration Sites Needed After the Start of Fluid Administration | 2 administration sites | 1 Participants |
| Intravenous Isotonic Fluid | Number of Participants With the Indicated Number of Different Anatomical Administration Sites Needed After the Start of Fluid Administration | 1 administration site | 59 Participants |
| Intravenous Isotonic Fluid | Number of Participants With the Indicated Number of Different Anatomical Administration Sites Needed After the Start of Fluid Administration | 2 administration sites | 0 Participants |
| Intravenous Isotonic Fluid: SC Rescued | Number of Participants With the Indicated Number of Different Anatomical Administration Sites Needed After the Start of Fluid Administration | 1 administration site | 15 Participants |
| Intravenous Isotonic Fluid: SC Rescued | Number of Participants With the Indicated Number of Different Anatomical Administration Sites Needed After the Start of Fluid Administration | 2 administration sites | 0 Participants |
Secondary
Number of Participants With the Indicated Number of Needle Stick Attempts Needed to Initiate Fluid Administration
Data are reported for the number of needle stick attempts needed to initiate fluid administration.
Time frame: average of approximately 3 minutes
Population: ITT Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Subcutaneous Hylenex | Number of Participants With the Indicated Number of Needle Stick Attempts Needed to Initiate Fluid Administration | 1 | 69 Participants |
| Subcutaneous Hylenex | Number of Participants With the Indicated Number of Needle Stick Attempts Needed to Initiate Fluid Administration | 2 | 4 Participants |
| Subcutaneous Hylenex | Number of Participants With the Indicated Number of Needle Stick Attempts Needed to Initiate Fluid Administration | 3 | 0 Participants |
| Subcutaneous Hylenex | Number of Participants With the Indicated Number of Needle Stick Attempts Needed to Initiate Fluid Administration | >3 | 0 Participants |
| Intravenous Isotonic Fluid | Number of Participants With the Indicated Number of Needle Stick Attempts Needed to Initiate Fluid Administration | >3 | 1 Participants |
| Intravenous Isotonic Fluid | Number of Participants With the Indicated Number of Needle Stick Attempts Needed to Initiate Fluid Administration | 1 | 54 Participants |
| Intravenous Isotonic Fluid | Number of Participants With the Indicated Number of Needle Stick Attempts Needed to Initiate Fluid Administration | 3 | 7 Participants |
| Intravenous Isotonic Fluid | Number of Participants With the Indicated Number of Needle Stick Attempts Needed to Initiate Fluid Administration | 2 | 13 Participants |
p-value: 0.0007Cochran-Mantel-Haenszel
Secondary
Number of Participants With the Indicated Reason for Rehospitalization Within 48 and 72 Hours After Discharge
Participants were discharged from the ED to home or the hospital to continue hydration therapy.
Time frame: from randomization up to approximately 98 hours
Population: ITT Population. Only those participants who were re-hospitalized or had an Emergency Department visit after initial discharge to home were analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Subcutaneous Hylenex | Number of Participants With the Indicated Reason for Rehospitalization Within 48 and 72 Hours After Discharge | Retreatment for dehydration | 2 Participants |
| Subcutaneous Hylenex | Number of Participants With the Indicated Reason for Rehospitalization Within 48 and 72 Hours After Discharge | Other | 7 Participants |
| Intravenous Isotonic Fluid | Number of Participants With the Indicated Reason for Rehospitalization Within 48 and 72 Hours After Discharge | Retreatment for dehydration | 2 Participants |
| Intravenous Isotonic Fluid | Number of Participants With the Indicated Reason for Rehospitalization Within 48 and 72 Hours After Discharge | Other | 8 Participants |
Secondary
Number of Participants With the Indicated Type of Adverse Events
Adverse events (AEs) are defined as any untoward medical occurrence in a participant administered a product, which did not necessarily have a causal relationship with the treatment. Treatment-emergent adverse events (TEAEs) are defined as those events that occurred on or after the first injection device insertion attempt.
Time frame: up to 7 days after hospital discharge
Population: Safety Population: all randomly assigned participants for whom the treatment was attempted (i.e., infusion device placement was initiated)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Subcutaneous Hylenex | Number of Participants With the Indicated Type of Adverse Events | At least 1 AE | 73 Participants |
| Subcutaneous Hylenex | Number of Participants With the Indicated Type of Adverse Events | At least 1 infusion site AE | 73 Participants |
| Subcutaneous Hylenex | Number of Participants With the Indicated Type of Adverse Events | at least 1 AE related to infusion fluid | 72 Participants |
| Subcutaneous Hylenex | Number of Participants With the Indicated Type of Adverse Events | At least 1 AE related to hylenex | 67 Participants |
| Intravenous Isotonic Fluid | Number of Participants With the Indicated Type of Adverse Events | At least 1 AE related to hylenex | 14 Participants |
| Intravenous Isotonic Fluid | Number of Participants With the Indicated Type of Adverse Events | At least 1 AE | 68 Participants |
| Intravenous Isotonic Fluid | Number of Participants With the Indicated Type of Adverse Events | at least 1 AE related to infusion fluid | 32 Participants |
| Intravenous Isotonic Fluid | Number of Participants With the Indicated Type of Adverse Events | At least 1 infusion site AE | 63 Participants |
Secondary
Number of Participants With the Indicated Type of Fluid Administered
Data are reported for the initial fluid administered.
Time frame: During the infusion (single bolus dose of hylenex [1 hr], followed by subcutaneous fluid for 1 hour to 72 hours)
Population: ITT Population. Only those participants for which fluid administration was initiated were analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Subcutaneous Hylenex | Number of Participants With the Indicated Type of Fluid Administered | Normal saline (NS) | 44 Participants |
| Subcutaneous Hylenex | Number of Participants With the Indicated Type of Fluid Administered | Other | 1 Participants |
| Subcutaneous Hylenex | Number of Participants With the Indicated Type of Fluid Administered | Lactated Ringers | 28 Participants |
| Subcutaneous Hylenex | Number of Participants With the Indicated Type of Fluid Administered | D5 1/2 NS without potassium chloride (KCL) | 0 Participants |
| Subcutaneous Hylenex | Number of Participants With the Indicated Type of Fluid Administered | D5 1/2 NS with KCL | 0 Participants |
| Intravenous Isotonic Fluid | Number of Participants With the Indicated Type of Fluid Administered | D5 1/2 NS without potassium chloride (KCL) | 1 Participants |
| Intravenous Isotonic Fluid | Number of Participants With the Indicated Type of Fluid Administered | Lactated Ringers | 9 Participants |
| Intravenous Isotonic Fluid | Number of Participants With the Indicated Type of Fluid Administered | Other | 0 Participants |
| Intravenous Isotonic Fluid | Number of Participants With the Indicated Type of Fluid Administered | Normal saline (NS) | 49 Participants |
| Intravenous Isotonic Fluid | Number of Participants With the Indicated Type of Fluid Administered | D5 1/2 NS with KCL | 0 Participants |
| Intravenous Isotonic Fluid: SC Rescued | Number of Participants With the Indicated Type of Fluid Administered | Other | 0 Participants |
| Intravenous Isotonic Fluid: SC Rescued | Number of Participants With the Indicated Type of Fluid Administered | Lactated Ringers | 6 Participants |
| Intravenous Isotonic Fluid: SC Rescued | Number of Participants With the Indicated Type of Fluid Administered | Normal saline (NS) | 9 Participants |
| Intravenous Isotonic Fluid: SC Rescued | Number of Participants With the Indicated Type of Fluid Administered | D5 1/2 NS with KCL | 0 Participants |
| Intravenous Isotonic Fluid: SC Rescued | Number of Participants With the Indicated Type of Fluid Administered | D5 1/2 NS without potassium chloride (KCL) | 0 Participants |
Secondary
Number of Participants With the Indicated Type of Rescue Route Therapy Administered
Participants for whom parenteral access by the randomized route of administration could not be achieved after a reasonable number of attempts and for whom the investigator had deemed the access by that route a failure were expected to receive fluid administration by other means, designated as rescue route for the purpose of this study. This rescue route may have included venous cut-down, central venous line, interosseous access, etc., and for those participants initially randomly assigned to IV fluid administration, SC fluid administration by hylenex-facilitated infusion.
Time frame: During the infusion (single bolus dose of hylenex [1 hr], followed by subcutaneous fluid for 1 hour to 72 hours)
Population: ITT Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Subcutaneous Hylenex | Number of Participants With the Indicated Type of Rescue Route Therapy Administered | hylenex-facilitated SC | 0 Participants |
| Subcutaneous Hylenex | Number of Participants With the Indicated Type of Rescue Route Therapy Administered | Other type of rescue | 0 Participants |
| Intravenous Isotonic Fluid | Number of Participants With the Indicated Type of Rescue Route Therapy Administered | hylenex-facilitated SC | 15 Participants |
| Intravenous Isotonic Fluid | Number of Participants With the Indicated Type of Rescue Route Therapy Administered | Other type of rescue | 0 Participants |
Secondary
Percent Change From Baseline in Body Weight
Percent change from Baseline was calculated as the (\[post-Baseline value minus the Baseline value\] / Baseline value) \* 100.
Time frame: Baseline; during the infusion (single bolus dose of hylenex [1 hr], followed by subcutaneous fluid for 1 hour to 72 hours)
Population: ITT Population. Only those participants contributing data at the indicated time point were assessed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Subcutaneous Hylenex | Percent Change From Baseline in Body Weight | 2.9 percent change | Standard Deviation 2.52 |
| Intravenous Isotonic Fluid | Percent Change From Baseline in Body Weight | 3.8 percent change | Standard Deviation 15.17 |
p-value: 0.620895% CI: [-4.8, 2.9]ANOVA
Secondary
Time From Randomization to the First Drop of Fluid Infusion
Data are reported for the time from randomization to the start of fluid infusion for all randomized participants.
Time frame: up to approximately 110 and 220 minutes for the SC and IV arms, respectively
Population: ITT Population. Only those participants for which fluid administration was initiated were analyzed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Subcutaneous Hylenex | Time From Randomization to the First Drop of Fluid Infusion | 37 minutes |
| Intravenous Isotonic Fluid | Time From Randomization to the First Drop of Fluid Infusion | 42.5 minutes |
p-value: 0.0247Wilcoxon (Mann-Whitney)
Secondary
Time From the Start of Infusion to the Time of Emergency Department (ED) Discharge
Data are reported from the start of infusion to the time of ED discharge.
Time frame: up to approximately 26 hours
Population: ITT Population. Only those participants for which fluid administration was initiated were analyzed. Only those participants with available data were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Subcutaneous Hylenex | Time From the Start of Infusion to the Time of Emergency Department (ED) Discharge | 4.0 hours | Standard Deviation 4.26 |
| Intravenous Isotonic Fluid | Time From the Start of Infusion to the Time of Emergency Department (ED) Discharge | 3.1 hours | Standard Deviation 1.92 |
| Intravenous Isotonic Fluid: SC Rescued | Time From the Start of Infusion to the Time of Emergency Department (ED) Discharge | 4.7 hours | Standard Deviation 4.64 |