Diarrhea
Conditions
Keywords
diarrhea
Brief summary
It is generally recommended that oral rehydration should be used as first-line therapy to treat or prevent dehydration in children with acute gastroenteritis (AGE). Refusal to drink regular Oral Rehydration Solution (ORS) interfere with compliance with the recommended treatment. The objective of this study is to compare the tolerance, acceptance, efficacy and safety of a new ORS (Hipp ORS 200 Apple) of improved palatability with regular ORS recommended by ESPGHAN in children with acute gastroenteritis (AGE).
Detailed description
It is generally recommended that oral rehydration should be used as first-line therapy to treat or prevent dehydration in children with acute gastroenteritis (AGE). Despite the proven efficacy of oral rehydration therapy it remains underused. The main reason for this is that an ORS neither reduces the frequency of bowel movements and fluid loss nor shortens the duration of illness, which decreases its acceptance. Moreover, unpalatability of regular ORS decrease its acceptance, especially in children with lower degrees of dehydration. Refusal to drink regular ORS interfere with compliance with the recommended treatment. Parents, but also health care professionals, demand safe, effective, inexpensive, but also well tolerated and accepted ORS for management of AGE. Recently, a new ORS (Hipp ORS 200 Apple) with improved taste has been developed, and is now frequently employed for the management of AGE. The proposed study will be the first double-blind randomized trial of this ORS. It will evaluate clinically meaningful benefits to be derived by children and caregivers from its use. If positive, this new ORS may become a routine recommendation for children with AGE. The objective of this study is to compare the tolerance, acceptance, efficacy and safety of a new ORS (Hipp ORS 200 Apple) with regular ORS recommended by ESPGHAN in children with AGE.
Interventions
DIETARY_SUPPLEMENToral rehydration solution Hipp ORS Apple 200
Volume of the solution calculated by weight: * fast oral rehydration in 3-4 hours by mouth * ORS given for ongoing losses until diarrhea stops (maintenance phase)
DIETARY_SUPPLEMENTESPGHAN ORS
Volume of the solution calculated by weight: * fast oral rehydration in 3-4 hours by mouth * ORS given for ongoing losses until diarrhea stops (maintenance phase)
Sponsors
Medical University of Warsaw
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
4 Months to 48 Months
Healthy volunteers
No
Inclusion criteria
* children age 4 to 48 months * diarrhoea defined as the passage of three or more loose or watery stools per day for \>1 but \<5 days * mild (3%) or moderate dehydration (3-9%) according to the World Health Organization criteria (Table 1) * informed consent signed by at least one parent / caregiver
Exclusion criteria
* diarrhea for \<1 or \>5 days * severe dehydration (\>9%) * recent history of diarrhea indicated either by parent/guardian or hospital case notes * underlying chronic gastrointestinal disease (i.e., celiac disease, cow's milk protein intolerance) * breastfeeding \>50% * under nutrition (weight/height ratio below the fifth percentile) * systemic infections * immune defects or immunosuppressive treatment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants That Were Successfully Rehydrated | Proportion of successfully rehydrated at 24 hours | The following components are included in primary outcome: * resolution of signs of dehydration * adequate weight gain * production of urine output during the trial |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ORS Intake at 4 h | 4 hrs | % of prescribed ORS that was consumed during first 4 hours |
| Unscheduled Intravenous Therapy | 24 hours | Need for intravenous therapy within 24 hours |
| Vomiting | 24 hours | Vomiting starting or progressing in the first 24 hours of therapy |
| ORS Intake in ml | 24 hours | ORS intake in ml (in the first 24 hours, and total) |
| Adverse Events | 24 hours | any adverse event, providing a description if related or not related to study intervention |
| Duration of Diarrhea (Hrs) | 7days | Time of diarrhea in hours |
| Return Visit to the Emergency Department | 1 week | Return visit to the emergency department within a week |
| Hospitalization | 1 week | need for hospitalization within a week |
| Weight Gain in Gram | 24 hours | Weight gain in gram (in the first 24 hours, and total) |
Countries
Poland
Participant flow
Recruitment details
This was a double blind, randomized controlled trial carried out in the emergency departments of 2 pediatric hospitals in Poland (The Medical University of Warsaw and St Hedvig of Silesia Hospital, Trzebnica).
Pre-assignment details
Of the 147 children who underwent randomization, 72 were assigned to the experimental group and 75 were assigned to the control group. 17 children discontinued the study and eventually were lost to follow-up. The reason for lost to follow-up: parents refusal (N=2), not attend to scheduled visit (N=12), diarry lost (N=2), randomization error (N=1).
Participants by arm
| Arm | Count |
|---|---|
| ESPGHAN ORS ESPGHAN oral rehydration solution
ESPGHAN ORS : Volume of the solution calculated by weight:
* fast oral rehydration in 3-4 hours by mouth
* ORS given for ongoing losses until diarrhea stops (maintenance phase) | 75 |
| Hipp ORS Apple 200 oral rehydration solution Hipp ORS 200 Apple
oral rehydration solution Hipp ORS Apple 200 : Volume of the solution calculated by weight:
* fast oral rehydration in 3-4 hours by mouth
* ORS given for ongoing losses until diarrhea stops (maintenance phase) | 72 |
| Total | 147 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 8 | 9 |
Baseline characteristics
| Characteristic | Hipp ORS Apple 200 | ESPGHAN ORS | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 72 Participants | 75 Participants | 147 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 | 1.6 years STANDARD_DEVIATION 0.8 | 1.8 years STANDARD_DEVIATION 0.5 | 1.75 years STANDARD_DEVIATION 0.89 |
| Region of Enrollment Poland | 72 participants | 75 participants | 147 participants |
| Sex: Female, Male Female | 29 Participants | 25 Participants | 54 Participants |
| Sex: Female, Male Male | 43 Participants | 50 Participants | 93 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 63 | 0 / 67 |
| serious Total, serious adverse events | 0 / 63 | 0 / 67 |
Outcome results
Primary
Number of Participants That Were Successfully Rehydrated
The following components are included in primary outcome: * resolution of signs of dehydration * adequate weight gain * production of urine output during the trial
Time frame: Proportion of successfully rehydrated at 24 hours
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ESPGHAN ORS | Number of Participants That Were Successfully Rehydrated | 57 Participants |
| Hipp ORS Apple 200 | Number of Participants That Were Successfully Rehydrated | 49 Participants |
p-value: 0.28t-test, 1 sided
Secondary
Adverse Events
any adverse event, providing a description if related or not related to study intervention
Time frame: 24 hours
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ESPGHAN ORS | Adverse Events | 0 participants |
| Hipp ORS Apple 200 | Adverse Events | 0 participants |
Secondary
Duration of Diarrhea (Hrs)
Time of diarrhea in hours
Time frame: 7days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ESPGHAN ORS | Duration of Diarrhea (Hrs) | 69.1 hrs | Standard Deviation 42.6 |
| Hipp ORS Apple 200 | Duration of Diarrhea (Hrs) | 61.9 hrs | Standard Deviation 38.6 |
Secondary
Hospitalization
need for hospitalization within a week
Time frame: 1 week
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ESPGHAN ORS | Hospitalization | 3 participants |
| Hipp ORS Apple 200 | Hospitalization | 5 participants |
Secondary
ORS Intake at 4 h
% of prescribed ORS that was consumed during first 4 hours
Time frame: 4 hrs
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ESPGHAN ORS | ORS Intake at 4 h | 33.6 percentage of prescribed ORS | Standard Deviation 21 |
| Hipp ORS Apple 200 | ORS Intake at 4 h | 33.2 percentage of prescribed ORS | Standard Deviation 24.1 |
Secondary
ORS Intake in ml
ORS intake in ml (in the first 24 hours, and total)
Time frame: 24 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ESPGHAN ORS | ORS Intake in ml | 52.4 ml | Standard Deviation 36.6 |
| Hipp ORS Apple 200 | ORS Intake in ml | 50.2 ml | Standard Deviation 34.6 |
Secondary
Return Visit to the Emergency Department
Return visit to the emergency department within a week
Time frame: 1 week
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ESPGHAN ORS | Return Visit to the Emergency Department | 0 participants |
| Hipp ORS Apple 200 | Return Visit to the Emergency Department | 0 participants |
Secondary
Unscheduled Intravenous Therapy
Need for intravenous therapy within 24 hours
Time frame: 24 hours
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ESPGHAN ORS | Unscheduled Intravenous Therapy | 3 participants |
| Hipp ORS Apple 200 | Unscheduled Intravenous Therapy | 5 participants |
Secondary
Vomiting
Vomiting starting or progressing in the first 24 hours of therapy
Time frame: 24 hours
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ESPGHAN ORS | Vomiting | 0 participants |
| Hipp ORS Apple 200 | Vomiting | 0 participants |
Secondary
Weight Gain in Gram
Weight gain in gram (in the first 24 hours, and total)
Time frame: 24 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ESPGHAN ORS | Weight Gain in Gram | 97 gram | Standard Deviation 198 |
| Hipp ORS Apple 200 | Weight Gain in Gram | 123 gram | Standard Deviation 167 |