Rehydration of children with severe malnutrition and gastroenteritis

Phase 2

• Conditions: Diarrhoea Severe Acute Malnutrition; Paediatrics

• Registration Number: PACTR202103852542919
• Lead Sponsor: Imperial College London

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-03-17
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

Children with SAM criteria (defined as any of: mid-upper arm circumference (MUAC) <11.5cm, WHZ <-3SD or kwashiorkor)
Diarrhoea (>3 loose stool/day)
Signs of severe dehydration

Exclusion Criteria

Diarrhoea lasting more than 14-days
Known congenital or rheumatic heart disease
Refusal of consent

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Stratum A intravenous rehydration Urine output (mls/kg/hour as a surrogate maker of rehydration efficacy;Stratum B Oral rehydration Change from randomisationbaseline plasma sodium level

Secondary Outcome Measures

Name	Time	Method
Safety outcomes (evidence of pulmonary oedema or heart failure);Development of electrolyte abnormalities (severe hyponatraemia <125 mmols/L or hypokalaemia <2.5 mol/L);Weight gain from randomisation/baseline ;Mortality