GastroSAM: Intravenous Rehydration for Severe Acute Malnutrition with Gastroenteritis
For over 25 years, treatment guidelines for children with severe acute malnutrition (SAM) and severe dehydration from gastroenteritis have been very different from those for well-nourished children. Well-nourished children usually receive rapid intravenous (IV) fluids with saline for over 3–5 hours to rehydrate them quickly. However, current guidance for children with SAM recommends giving low-salt oral rehydration solutions (ORS) by mouth, while IV fluids are only given if they go into circulatory collapse or shock.
This cautious approach is based on concerns that malnourished children’s hearts are weaker and unable to tolerate IV fluids. The restrictive standards of care for rehydrating children with SAM are mostly based on expert opinions rather than strong scientific evidence. Despite these careful approach in the current standard of care, death rates remain high.
Considering this, researchers from Médecins Sans Frontières (MSF), Imperial College London, and University College London (UCL) worked together to carefully study the safety and effectiveness of IV rehydration in children with SAM and dehydration, exploring whether more liberal rehydration strategies can improve outcomes.
The GastroSAM trial, recently published in the New England Journal of Medicine, was conducted Niger, Nigeria, Uganda, and Kenya. It involved 272 children aged between 6 months and 12 years, hospitalized with SAM and severe dehydration caused by diarrhea. Most participants were recruited from Médecins Sans Frontières (MSF)-supported sites in Nigeria and Niger.
The trial compared the safety of three rehydration strategies, with children randomly assigned to one of the following groups:
- Current WHO standard of care: Oral rehydration with IV fluids reserved only for cases of poor circulation (control group).
- Rapid IV rehydration: The standard approach typically used for well-nourished children.
- Slow IV rehydration: The same volume as the rapid IV group but administered more slowly.
As part of the GastroSAM consortium, LuxOR played a crucial role in providing operational research support, specifically in Nilefa Keji hospital in Maiduguri —coordinating teams, strengthening research capacity, and ensuring rigorous implementation across the study sites.
Dr. Temmy Sunyoto, Senior Operational Research Advisor, reflected on the challenges and resilience of the team:
MSF team in Maiduguri
Running a clinical trial in a context such as Maiduguri is challenging: the 2024 malnutrition peak has stretched the hospital to its limits, torrential floods have cut off access, and community protests even forced us to pause recruitment. Yet, despite every setback, the MSF’s Maiduguri team’s skill and determination shine through, driving research that hopefully will help transform care for the vulnerable children we serve. The low mortality and remarkable adherence to protocol, is a testament to the excellent conduct of GastroSAM trial – with strong collaboration amongst all involved
The trial found no difference in mortality between the intravenous (IV) rehydration groups and the standard oral rehydration strategy up to 96 hours. Overall mortality was also lower than expected, likely due to the close care and monitoring provided during the trial.
Crucially, no cases of heart failure or fluid overload were observed, indicating that IV rehydration was safe in children with SAM. Conversely, the oral rehydration strategy often required nasogastric tube insertion, which was associated with higher rates of vomiting and shock.
Dr. Kemi Ogundipe, Paediatric/Child Health Adviser at MSF Belgium, emphasized the significance of the findings:
Gastroenteritis with dehydration is the most common reason for admission in many inpatient nutrition wards and when these children are severely dehydrated, they are often very sick and require timely treatment. The results of this study could remove a large barrier to adequately rehydrating these children on time by showing that there are more options to safely do this especially for those who cannot keep any liquids down when oral rehydration is attempted
These findings suggest that current treatment guidelines could be simplified by removing distinctions between severely malnourished and well-nourished children in rehydration protocols and improving the safety of rehydration in often overwhelmed paediatric and nutrition wards.