Acute Bronchiolitis
Conditions
Keywords
Bronchiolitis, Hypertonic saline, Emergency Department
Brief summary
This is a randomized, double-blind, controlled trial in the Pediatric Emergency Department. The primary objective is to determine whether nebulized 3% hypertonic saline is more effective than nebulized 0.9% saline in the treatment of bronchiolitis in the emergency department.
Interventions
Within 5-15 minutes following the administration of the study drug, the Respiratory Distress Assessment Instrument (RDAI) score will be reassessed and study interventions are complete. The patient will be observed for one hour in the emergency department (ED). However, further treatments may be started immediately upon discretion of the treating physician. If the patient is discharged home study PI and/or research assistant will call the parents 7 days from the ED visit to check the number of visits to their primary doctor and/or EDs due to same illness.
Within 5-15 minutes following the administration of the study drug, the Respiratory Distress Assessment Instrument (RDAI) score will be reassessed and study interventions are complete. The patient will be observed for one hour in the emergency department (ED). However, further treatments may be started immediately upon discretion of the treating physician. If the patient is discharged home study PI and/or research assistant will call the parents 7 days from the ED visit to check the number of visits to their primary doctor and/or EDs due to same illness.
Sponsors
University of Texas Southwestern Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
2 Months to 12 Months
Healthy volunteers
No
Inclusion criteria
* Children 2-12 months of age presenting to Emergency Department * Patients with a diagnosis of bronchiolitis defined as the first episode of wheezing and/or crackles in a child younger than 12 months who has physical findings of a viral respiratory infection and has no other explanation for the wheezing and/or crackles * Patients with an RDAI score ≥ 6 as measured by a trained respiratory therapist
Exclusion criteria
* Previous history of wheezing * Known heart or lung disease * Premature birth defined as birth before 37 weeks gestation * Immunosuppression or immunodeficiency * Treatment with corticosteroids in the previous 48 hours * Critically ill children - progressive respiratory failure requiring higher level of care, vital signs instability/need for emergency interventions to prevent clinical deterioration * Oxygen saturation \<85% on room air at the time of recruitment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Respiratory Assessment Change Score (RACS) | 5-15 minutes | The primary outcome variable is the Respiratory Assessment Change Score (RACS) which is a sum of the change in the Respiratory Distress Assessment Instrument (RDAI)score plus a standardized score for the change in respiratory rate; the change in respiratory rate is assigned 1 point per each 10% change in the respiratory rate.The RDAI score is the sum of the row scores, with total range 0 to 17; higher scores indicate more severe disease. |
Secondary
| Measure | Time frame |
|---|---|
| Rate of Hospitalizations | 24 hours |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 3% Hypertonic Saline Group Once consented, the study drug (in this arm: 3% Hypertonic Saline) will be ordered by a physician at the request of a study team member. Once the drug order set is received by a pharmacist, he/she will obtain the study drug from an Omnicell and prepare the medication to a volume of 3 mL in a syringe with a blinded study label prepared in advance by the IDS pharmacy. The pharmacist will then give the study drug to the patient's respiratory therapist or the bedside nurse. The respiratory therapist or the nurse will pour the drug from a syringe to an inhaler cup and the study drug will be given by the standard nebulizer over the course of 15 minutes.
Within 5-15 minutes following the administration of the study drug, the Respiratory Distress Assessment Instrument (RDAI) score will be reassessed and study interventions are complete. The patient will be observed for one hour in the emergency department (ED). However, further treatments m | 25 |
| 0.9% Normal Saline Group Once consented, the study drug (in this arm: 0.9% normal saline) will be ordered by a physician at the request of a study team member. Once the drug order set is received by a pharmacist, he/she will obtain the study drug from an Omnicell and prepare the medication to a volume of 3 mL in a syringe with a blinded study label prepared in advance by the IDS pharmacy. The pharmacist will then give the study drug to the patient's respiratory therapist or the bedside nurse. The respiratory therapist or the nurse will pour the drug from a syringe to an inhaler cup and the study drug will be given by the standard nebulizer over the course of 15 minutes.
Within 5-15 minutes following the administration of the study drug, the Respiratory Distress Assessment Instrument (RDAI) score will be reassessed and study interventions are complete. The patient will be observed for one hour in the emergency department (ED). However, further treatments may | 27 |
| Total | 52 |
Baseline characteristics
| Characteristic | 0.9% Normal Saline Group | 3% Hypertonic Saline Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 27 Participants | 25 Participants | 52 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 9.2 months STANDARD_DEVIATION 5.4 | 9.8 months STANDARD_DEVIATION 6.3 | 9.6 months STANDARD_DEVIATION 5.6 |
| Region of Enrollment United States | 27 participants | 25 participants | 52 participants |
| Sex: Female, Male Female | 10 Participants | 7 Participants | 17 Participants |
| Sex: Female, Male Male | 17 Participants | 18 Participants | 35 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 25 | 0 / 27 |
| other Total, other adverse events | 0 / 25 | 0 / 27 |
| serious Total, serious adverse events | 0 / 25 | 0 / 27 |
Outcome results
Primary
Respiratory Assessment Change Score (RACS)
The primary outcome variable is the Respiratory Assessment Change Score (RACS) which is a sum of the change in the Respiratory Distress Assessment Instrument (RDAI)score plus a standardized score for the change in respiratory rate; the change in respiratory rate is assigned 1 point per each 10% change in the respiratory rate.The RDAI score is the sum of the row scores, with total range 0 to 17; higher scores indicate more severe disease.
Time frame: 5-15 minutes
| Arm | Measure | Value (MEAN) |
|---|---|---|
| 3% Hypertonic Saline Group | Respiratory Assessment Change Score (RACS) | 1.68 score on a scale |
| 0.9% Normal Saline Group | Respiratory Assessment Change Score (RACS) | 1.70 score on a scale |
Secondary
Rate of Hospitalizations
Time frame: 24 hours
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 3% Hypertonic Saline Group | Rate of Hospitalizations | 9 participants |
| 0.9% Normal Saline Group | Rate of Hospitalizations | 11 participants |