Study Background and Disease Burden
Severe acute malnutrition (SAM) remains a major contributor to childhood morbidity and mortality in low-resource settings, particularly sub-Saharan Africa. Gastroenteritis often complicates SAM by causing significant dehydration, which necessitates prompt rehydration to reduce fatal outcomes. Current international guidelines caution against intravenous (IV) fluid administration in children with SAM due to concerns of fluid overload, heart failure, and pulmonary edema, despite the fact that supportive evidence for these concerns is limited. Consequently, oral rehydration therapy (ORT) is favored as the primary modality, even though its efficacy may be compromised by gastrointestinal dysfunction or shock. The persistent high mortality rates in this population call for re-evaluation of optimal rehydration strategies, including the potential role of intravenous fluids. This context motivated the GASTROSAM trial to assess safety and efficacy of intravenous rehydration compared with oral strategies in children with SAM and gastroenteritis-induced dehydration.
