Severely malnourished children can be safely rehydrated intravenously, according to GASTROSAM trial

13 Jun 2025

Results from the GASTROSAM clinical trial offer new insights into how to improve treatment for children suffering from severe acute malnutrition (SAM) and gastroenteritis, two of the leading causes of illness and death in young children globally. These results were published today in the New England Journal of Medicine.

GASTROSAM is a randomised controlled clinical trial that compared different methods for treating nearly 300 very ill children aged 12 and under who had severe acute malnutrition, across four African countries. The trial was led by Imperial College London’s Institute of Global Health Innovation, in close collaboration with MRC CTU at UCL and Médecins Sans Frontières.

It’s estimated that 17 million children worldwide are severely undernourished. The most extreme form – severe acute malnutrition, or SAM – is a leading cause of paediatric hospital admissions in Africa. But international guidance on rehydrating children with SAM who have severe dehydration due to gastroenteritis differs from that for children who aren’t classed as severely malnourished.

Rather than having fluids replaced quickly via an intravenous drip, children with SAM are recommended to be given rehydration solutions orally. This is based on an expert opinion that children with severe malnutrition have a weaker functioning heart and may not be able to tolerate intravenous rehydration or standard saline solutions.

But with a lack of evidence for that opinion, high mortality rates have led some to wonder whether adopting intravenous rehydration treatment might improve outcomes.

To address this question, GASTROSAM compared the safety of different rehydration strategies. The trial included 272 children hospitalised with SAM, involving dehydration caused by diarrhoea. They were randomised into one of three groups:

Current standard of care recommended by the WHO, based on oral rehydration with the use of IV fluids only in cases of shock (control).

Rapid IV rehydration, typically used for non-malnourished children (liberal, rapid)

Slow IV rehydration, the same volume of fluid as for rapid IV rehydration but administered slowly (liberal, slow)

The study was carried out in Niger, Nigeria, Uganda and Kenya.

The trial found no evidence of a difference in mortality after 96 hours compared to the standard control strategy. Among the children in the trial, mortality overall was lower than expected, although this is likely to be due to the close care and monitoring provided to the children during the trial.

Most importantly, there were no differences between heart failure or fluid overload events between groups, indicating that the intravenous approaches to rehydration were not harmful. In fact, they found that the standard oral strategy often meant that the children needed to have a nasogastric tube fitted to deliver the rehydration fluids, and that this was associated with more episodes of vomiting and shock.

GASTROSAM found that rehydrating children by using fluids via an intravenous (IV) drip did not cause them any harmful effects, showing that intravenous rehydration is no less safe than the oral rehydration that is currently recommended.

These results open the possibility of a review of existing guidance worldwide; in particular, a simplification of the recommendations that would remove the distinction between malnourished and non-malnourished children and adopt intravenous rehydration treatment.

The results from GASTROSAM will be shared with global health bodies and policymakers to support evidence-based updates to clinical guidelines for managing SAM in emergency and hospital settings.

GASTROSAM was funded by the Joint Global Health Trials Scheme of the United Kingdom’s Medical Research Council, the UK Department for International Development and Wellcome (Grant Number MR/R018502/1) and by Médecins Sans Frontières.

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