A landmark randomized controlled trial has demonstrated that intravenous rehydration can be safely administered to severely malnourished children with gastroenteritis, potentially overturning decades-old treatment guidelines that have favored oral rehydration for this vulnerable population.
The GASTROSAM trial, led by Professor Kathryn Maitland at Imperial College London's Institute of Global Health Innovation and published in the New England Journal of Medicine, compared different rehydration strategies in 292 children aged 12 and under across Niger, Nigeria, Uganda, and Kenya. All participants were hospitalized with severe acute malnutrition (SAM) and dehydration caused by diarrhea.
Trial Design Challenges Current Practice
Current World Health Organization guidelines recommend oral rehydration solutions for children with SAM, often delivered via nasogastric tube, based on expert opinion that these children have compromised cardiac function and cannot tolerate intravenous fluids. This approach differs markedly from treatment protocols for non-malnourished children with gastroenteritis, who routinely receive IV rehydration.
The trial randomized children into three treatment groups: the current WHO standard of care using oral rehydration with IV fluids only for poor circulation (control group), rapid IV rehydration typically used for non-malnourished children, and slow IV rehydration using the same fluid volume but administered over a longer period.
Safety Concerns Prove Unfounded
The study's most significant finding was the absence of heart failure or fluid overload events in children receiving intravenous treatment—the very complications that current guidelines aim to prevent. "Most importantly, they found no events of heart failure or fluid overload—indicating that the intravenous approaches to rehydration were not harmful," the researchers reported.
Mortality rates showed no significant difference between treatment groups after 96 hours, with overall mortality lower than expected across all groups, likely due to the intensive monitoring provided during the trial.
Oral Rehydration Shows More Complications
Paradoxically, children receiving the current standard oral rehydration experienced more treatment-related complications. These patients required more nasogastric tube insertions for fluid delivery and experienced increased episodes of vomiting and shock requiring emergency intravenous intervention.
Professor Maitland emphasized the clinical urgency: "Children with severe acute malnutrition and dehydration are very sick, so it's crucial we can get them the best possible treatment and fast. The current treatment plans are based on expert opinion, but outcomes for children with SAM are still poor."
Global Health Implications
The findings carry significant implications for the estimated 17 million children worldwide who are severely undernourished. Severe acute malnutrition represents a leading cause of pediatric hospital admissions across Africa, making treatment optimization crucial for reducing child mortality.
The research team, which included collaborators from University College London and Médecins Sans Frontières, conducted the majority of patient recruitment at sites where MSF teams operate, ensuring real-world clinical relevance.
Pathway to Guideline Reform
The study's results will be shared with global health bodies and policymakers to support evidence-based updates to clinical guidelines. The researchers suggest their findings could lead to simplified recommendations that remove the distinction between rehydration treatments for malnourished and non-malnourished children.
"We hope our findings help to close the evidence gap and will ultimately help to improve treatment and outcomes for these children," Professor Maitland stated, highlighting the study's potential to address long-standing treatment disparities.
The research was funded by the Joint Global Health Trials Scheme of the UK's Medical Research Council, the UK Department for International Development, Wellcome, and Médecins Sans Frontières, reflecting the international commitment to improving pediatric malnutrition treatment protocols.
