Gastroenteritis Rehydration Of children with Severe Acute Malnutrition (GASTROSAM): A Phase II Randomised Controlled trial
Can children with severe acute malnutrition (SAM) and gastroenteritis be safely rehydrated with other rehydration strategies compared to the WHO SAM strategy and what is the best oral rehydration solution to use in these children?
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
Who is funding the study?
Global Health Trials Development grant by the MRC and Wellcome Trust
When is it taking place?
March 2018 – March 2022
Where is it taking place?
Uganda (Mbale Regional Referral Hospital and Soroti Regional Referral Hospital) and Kenya (Kilifi Hospital)
Who is included?
200 Children aged 6months to 12 years with severe acute malnutrition (SAM) hospitalised with gastroenteritis and signs of dehydration