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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hipp ORS Apple 200 | Experimental | oral rehydration solution Hipp ORS 200 Apple |
|
| ESPGHAN ORS | Active Comparator | ESPGHAN oral rehydration solution |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| oral rehydration solution Hipp ORS Apple 200 | Dietary Supplement | Volume of the solution calculated by weight:
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants That Were Successfully Rehydrated | The following components are included in primary outcome:
| Proportion of successfully rehydrated at 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Unscheduled Intravenous Therapy | Need for intravenous therapy within 24 hours | 24 hours |
| Vomiting | Vomiting starting or progressing in the first 24 hours of therapy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hania Szajewska, Professor | Medical University of Warsaw | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Peadiatrics, The Medical University of Warsaw | Warsaw | 01-183 | Poland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18493225 | Background | Guarino A, Albano F, Ashkenazi S, Gendrel D, Hoekstra JH, Shamir R, Szajewska H; ESPGHAN/ESPID Evidence-Based Guidelines for the Management of Acute Gastroenteritis in Children in Europe Expert Working Group. European Society for Paediatric Gastroenterology, Hepatology, and Nutrition/European Society for Paediatric Infectious Diseases evidence-based guidelines for the management of acute gastroenteritis in children in Europe: executive summary. J Pediatr Gastroenterol Nutr. 2008 May;46(5):619-21. doi: 10.1097/MPG.0b013e31816e219e. No abstract available. | |
| 1573500 |
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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).
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).
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| ID | Title | Description |
|---|---|---|
| FG000 | ESPGHAN ORS | ESPGHAN oral rehydration solution ESPGHAN ORS : Volume of the solution calculated by weight:
|
| FG001 | 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:
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| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | ESPGHAN ORS | ESPGHAN oral rehydration solution ESPGHAN ORS : Volume of the solution calculated by weight:
|
| BG001 | Hipp ORS Apple 200 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants That Were Successfully Rehydrated | The following components are included in primary outcome:
| Posted | Number | Participants | Proportion of successfully rehydrated at 24 hours |
|
7 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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:
|
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Potential limitations included lack of perfect blinding. Because of technological reasons, it was not feasible to produce study products that were identical in colour, smell and taste.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Hanna Szajewska, Malgorzata Piescik-Lech | The Medical University of Warsaw | +48-22-45-23-309 | hania@ipgate.pl |
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| ID | Term |
|---|---|
| D003967 | Diarrhea |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ESPGHAN ORS | Dietary Supplement | Volume of the solution calculated by weight:
|
|
| 24 hours |
| ORS Intake in ml | ORS intake in ml (in the first 24 hours, and total) | 24 hours |
| Weight Gain in Gram | Weight gain in gram (in the first 24 hours, and total) | 24 hours |
| Duration of Diarrhea (Hrs) | Time of diarrhea in hours | 7days |
| Return Visit to the Emergency Department | Return visit to the emergency department within a week | 1 week |
| Hospitalization | need for hospitalization within a week | 1 week |
| Adverse Events | any adverse event, providing a description if related or not related to study intervention | 24 hours |
| ORS Intake at 4 h | % of prescribed ORS that was consumed during first 4 hours | 4 hrs |
| Background |
| Recommendations for composition of oral rehydration solutions for the children of Europe. Report of an ESPGAN Working Group. J Pediatr Gastroenterol Nutr. 1992 Jan;14(1):113-5. No abstract available. |
| 10817282 | Background | Szajewska H, Hoekstra JH, Sandhu B; ESPGHAN Working Group on Acute Diarrhoea. Management of acute gastroenteritis in Europe and the impact of the new recommendations: a multicenter study. The Working Group on acute Diarrhoea of the European Society for Paediatric Gastroenterology, Hepatology, and Nutrition. J Pediatr Gastroenterol Nutr. 2000 May;30(5):522-7. doi: 10.1097/00005176-200005000-00011. |
| 22860693 | Derived | Piescik-Lech M, Szymanski H, Szajewska H. Efficacy and safety of a new apple-flavoured oral rehydration solution in children with acute gastroenteritis: a double-blind randomized controlled trial. Acta Paediatr. 2012 Oct;101(10):e458-64. doi: 10.1111/j.1651-2227.2012.02782.x. Epub 2012 Aug 3. |
oral rehydration solution Hipp ORS 200 Apple oral rehydration solution Hipp ORS Apple 200 : Volume of the solution calculated by weight:
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
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|
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| Secondary | Unscheduled Intravenous Therapy | Need for intravenous therapy within 24 hours | Posted | Number | participants | 24 hours |
|
|
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| Secondary | Vomiting | Vomiting starting or progressing in the first 24 hours of therapy | Posted | Number | participants | 24 hours |
|
|
|
| Secondary | ORS Intake in ml | ORS intake in ml (in the first 24 hours, and total) | Posted | Mean | Standard Deviation | ml | 24 hours |
|
|
|
| Secondary | Weight Gain in Gram | Weight gain in gram (in the first 24 hours, and total) | Posted | Mean | Standard Deviation | gram | 24 hours |
|
|
|
| Secondary | Duration of Diarrhea (Hrs) | Time of diarrhea in hours | Posted | Mean | Standard Deviation | hrs | 7days |
|
|
|
| Secondary | Return Visit to the Emergency Department | Return visit to the emergency department within a week | Posted | Number | participants | 1 week |
|
|
|
| Secondary | Hospitalization | need for hospitalization within a week | Posted | Number | participants | 1 week |
|
|
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| Secondary | Adverse Events | any adverse event, providing a description if related or not related to study intervention | Posted | Number | participants | 24 hours |
|
|
|
| Secondary | ORS Intake at 4 h | % of prescribed ORS that was consumed during first 4 hours | Posted | Mean | Standard Deviation | percentage of prescribed ORS | 4 hrs |
|
|
|
| 0 |
| 63 |
| 0 |
| 63 |
| EG001 | ESPGHAN ORS | ESPGHAN oral rehydration solution ESPGHAN ORS: Volume of the solution calculated by weight:
| 0 | 67 | 0 | 67 |
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