Trial Outcomes & Findings for Efficacy and Safety of a New Oral Rehydration Solution (Hipp ORS 200 Apple) in Children With Acute Gastroenteritis (NCT NCT01467570)

NCT ID: NCT01467570

Last Updated: 2014-04-01

Results Overview

The following components are included in primary outcome: * resolution of signs of dehydration * adequate weight gain * production of urine output during the trial

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 147 participants
• Primary outcome timeframe: Proportion of successfully rehydrated at 24 hours
• Results posted on: 2014-04-01

Participant Flow

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).

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).

Participant milestones

Measure	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)	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)
Overall Study STARTED	75	72
Overall Study COMPLETED	67	63
Overall Study NOT COMPLETED	8	9

Reasons for withdrawal

Measure	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)	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)
Overall Study Lost to Follow-up	8	9

Baseline Characteristics

Efficacy and Safety of a New Oral Rehydration Solution (Hipp ORS 200 Apple) in Children With Acute Gastroenteritis

Baseline characteristics by cohort

Measure	ESPGHAN ORS n=75 Participants 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)	Hipp ORS Apple 200 n=72 Participants 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)	Total n=147 Participants Total of all reporting groups
Age, Categorical <=18 years	75 Participants n=5 Participants	72 Participants n=7 Participants	147 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	1.8 years STANDARD_DEVIATION 0.5 • n=5 Participants	1.6 years STANDARD_DEVIATION 0.8 • n=7 Participants	1.75 years STANDARD_DEVIATION 0.89 • n=5 Participants
Sex: Female, Male Female	25 Participants n=5 Participants	29 Participants n=7 Participants	54 Participants n=5 Participants
Sex: Female, Male Male	50 Participants n=5 Participants	43 Participants n=7 Participants	93 Participants n=5 Participants
Region of Enrollment Poland	75 participants n=5 Participants	72 participants n=7 Participants	147 participants n=5 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Measure	ESPGHAN ORS n=63 Participants 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)	Hipp ORS Apple 200 n=67 Participants 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)
Number of Participants That Were Successfully Rehydrated	49 Participants	57 Participants

SECONDARY outcome

Timeframe: 24 hours

Need for intravenous therapy within 24 hours

Outcome measures

Measure	ESPGHAN ORS n=67 Participants 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)	Hipp ORS Apple 200 n=63 Participants 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)
Unscheduled Intravenous Therapy	5 participants	3 participants

SECONDARY outcome

Timeframe: 24 hours

Vomiting starting or progressing in the first 24 hours of therapy

Outcome measures

Measure	ESPGHAN ORS n=67 Participants 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)	Hipp ORS Apple 200 n=63 Participants 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)
Vomiting	0 participants	0 participants

SECONDARY outcome

Timeframe: 24 hours

ORS intake in ml (in the first 24 hours, and total)

Outcome measures

Measure	ESPGHAN ORS n=67 Participants 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)	Hipp ORS Apple 200 n=63 Participants 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)
ORS Intake in ml	50.2 ml Standard Deviation 34.6	52.4 ml Standard Deviation 36.6

SECONDARY outcome

Timeframe: 24 hours

Weight gain in gram (in the first 24 hours, and total)

Outcome measures

Measure	ESPGHAN ORS n=67 Participants 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)	Hipp ORS Apple 200 n=63 Participants 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)
Weight Gain in Gram	123 gram Standard Deviation 167	97 gram Standard Deviation 198

SECONDARY outcome

Timeframe: 7days

Time of diarrhea in hours

Outcome measures

Measure	ESPGHAN ORS n=67 Participants 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)	Hipp ORS Apple 200 n=63 Participants 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)
Duration of Diarrhea (Hrs)	61.9 hrs Standard Deviation 38.6	69.1 hrs Standard Deviation 42.6

SECONDARY outcome

Timeframe: 1 week

Return visit to the emergency department within a week

Outcome measures

Measure	ESPGHAN ORS n=67 Participants 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)	Hipp ORS Apple 200 n=63 Participants 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)
Return Visit to the Emergency Department	0 participants	0 participants

SECONDARY outcome

Timeframe: 1 week

need for hospitalization within a week

Outcome measures

Measure	ESPGHAN ORS n=67 Participants 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)	Hipp ORS Apple 200 n=63 Participants 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)
Hospitalization	5 participants	3 participants

SECONDARY outcome

Timeframe: 24 hours

any adverse event, providing a description if related or not related to study intervention

Outcome measures

Measure	ESPGHAN ORS n=67 Participants 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)	Hipp ORS Apple 200 n=63 Participants 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)
Adverse Events	0 participants	0 participants

SECONDARY outcome

Timeframe: 4 hrs

% of prescribed ORS that was consumed during first 4 hours

Outcome measures

Measure	ESPGHAN ORS n=63 Participants 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)	Hipp ORS Apple 200 n=67 Participants 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)
ORS Intake at 4 h	33.2 percentage of prescribed ORS Standard Deviation 24.1	33.6 percentage of prescribed ORS Standard Deviation 21

Adverse Events

Hipp ORS Apple 200

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

ESPGHAN ORS

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Hanna Szajewska, Malgorzata Piescik-Lech

The Medical University of Warsaw

Phone: +48-22-45-23-309

Email: hania@ipgate.pl

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place