GASTROSAM

What is this study about?

This is a Phase II trial, with a partial factorial design, enrolling children aged 6 months to 12 years with severe acute malnutrition (SAM) hospitalised with gastroenteritis (>3 loose stools/day) and signs of dehydration.  In Stratum A (severe dehydration) children will be randomised (1:1:2) to an arm following WHO Plan C (100mls/kg Ringers Lactate (RL) over 3-6 hours according to age including boluses for shock), or to slow rehydration (100 mls/kg RL over 8 hours (no boluses) or to the WHO SAM rehydration regime: Oral rehydration only (boluses for shock (standard of care)).  Stratum B includes children with some dehydration that were not randomised to an IV rehydration arm and Stratum B and A together are included in a comparison of standard WHO oral rehydration solution usually given for non-SAM children (and is thus the experimental arm) versus WHO SAM-recommended low-sodium ReSoMal. The primary outcome for IV rehydration is urine output at 8 hours and for oral rehydration it is sodium levels at 24 hours. Secondary outcomes include adverse events and other measures of feasibility and safety. 

Type of study

Randomised trial

Who is funding the study?

Global Health Trials Development grant by the MRC and Wellcome Trust