Sucrose Solution for Pediatric Gastroenteritis

(STAGE Trial)

Overseen By Jocelyn Gravel, MD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Jocelyn Gravel

Disqualifiers: Severe dehydration, Hypoglycemia, Chronic disease, others

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

238 Participants Needed

Trial Summary

What is the purpose of this trial?

Background: Acute viral gastroenteritis is a very common pediatric medical condition that results in a large number of emergency department (ED) visits. Fasting-induced ketosis has been suggested to contribute to nausea and vomiting in children with VGE. To date, there is no data on the impact of oral sucrose intake during oral rehydration. Objective: The aim of this study is to assess the impact of providing a sucrose solution at triage to young children with suspected acute viral gastroenteritis on the amount of rehydration solution intake in the first 2 hours. We will also assess the proportion of discharge after initial medical evaluation, the proportion of oral rehydration failure, the number of vomiting episodes per patient, ondansetron administration, the time between the intervention and ED discharge, the time between the first medical contact and ED discharge and return visits within 48 hours. Methods: This study will be a double-blind randomized controlled trial. Recruitment will take place in a tertiary pediatric ED. Participants will be all children who present to the ED with suspected acute acute viral gastroenteritis with at least three vomiting in the previous 24 hours. The intervention will consist in giving 1.5 ml/kg of a sucrose solution composed of diluted juice with added table sugar (3.5g of sucrose/10 ml) compared with 1.5 ml/kg of diluted juice (0.5g of sucrose/10 mL, standard of care in our ED). Following that, all participants will be rehydrated with 15 mL of diluted juice every 15 minutes or more if tolerated. The primary outcome will be the amount of rehydration solution (ml) absorbed in the first two hours following intervention. Secondary outcomes will include disposition after initial medical evaluation, oral rehydration failure, the number of vomiting, ondansetron administration, the time between the intervention and ED discharge, the time between the first medical contact and ED discharge and return visits within 48 hours. The primary analysis will be the difference in the amount of tolerated oral rehydration between the two groups. Based on a preliminary study of children suffering from VGE, it was estimated that the recruitment of 238 participants would provide a power of 80% to identify a difference of 15 ml between the two groups. Expected results: We hope that this study will demonstrate that an oral sucrose solution given at triage to children presenting with symptoms compatible with acute acute viral gastroenteritis promotes oral hydration and consequently increases the total amount of rehydration solution tolerated by children.

Eligibility Criteria

This trial is for children aged 6 months to 6 years who have had at least three episodes of non-bilious, non-bloody vomiting in the past day and are suspected of having acute viral gastroenteritis. It excludes those with severe dehydration, bilious or bloody vomiting, previous study participation, chronic diseases (except asthma), hypoglycemia, or if parental consent cannot be obtained.

Inclusion Criteria

No other diagnostic more likely than acute viral gastroenteritis suspected at triage

My child is between 6 months and 6 years old.

I have vomited at least 3 times in the last day without blood or bile.

Exclusion Criteria

Inability to obtain parental informed consent (language barrier, absence, etc.)

I have a chronic condition that is not asthma.

Previous inclusion in the study

Timeline

Screening

Participants are screened for eligibility to participate in the trial

Immediate

1 visit (in-person)

Intervention

Participants receive either a sucrose solution or a placebo at triage

2 hours

1 visit (in-person)

Observation

Participants are monitored for oral rehydration success and other outcomes

6 hours

1 visit (in-person)

Follow-up

Participants are monitored for return visits and other outcomes post-discharge

48 hours

Treatment Details

Interventions

• Sucrose

Trial Overview The trial tests whether giving a sucrose solution (1.5 ml/kg) made from diluted juice with added sugar helps young children with gastroenteritis absorb more rehydration solution within two hours compared to standard care. This double-blind randomized controlled trial will measure intake of rehydration fluids and other outcomes like discharge rates and return visits.

Participant Groups

Group I: Sucrose Experimental Treatment 1 Intervention

The experimental arm will receive 1.5 ml/kg of the sucrose solution at triage (once). The composition of the homemade sucrose solution used in our emergency department is 3.5 g of table sugar (sucrose) mixed with 10 ml of diluted juice (see standard arm description) to obtain a solution with the same appearance as the standard arm.

Group II: Control Placebo Group 1 Intervention

This group will receive 1.5 mL/kg of diluted juice composed of juice (apple or orange) and water in equal proportion once at triage. This solution contains 0.05 g/ml of sucrose for a total of 0.075 g/kg of sucrose (eight times less than the intervention arm).

Who Is Running the Clinical Trial?

Jocelyn Gravel

Lead Sponsor

Trials

1

Recruited

240+