Co-SAM

We believe there is an urgent need to improve recovery in children with complicated severe acute malnutrition (SAM) after they leave hospital, by tackling underlying medical and social causes of ill-health. In this project, we bring together two networks of researchers from southern and east Africa with extensive experience in SAM.

The team secured a grant of £4.9 million from National Institute for Health and Care Research (NIHR) to undertake this project.

A Phase III trial will start in 2023, enrolling 1266 children with complicated SAM in Zambia, Zimbabwe and Kenya. There are five interventional arms which children may be randomly allocated to, for a 12 week intervention period:

• Standard of care (double size) – Children in this arm will receive care according to current best practice with no extra intervention
• Antimicrobial – Children will receive a bundle of extra medications that have been chosen to address broad infection prevention
• Reformulated ready-to-use therapeutic food (RUTF) – We are working with Nutriset, France, to develop a new version of RUTF that we hope will reduce metabolic stress and inflammation, and increase nutrient bioavailability
• Psychosocial – These children will receive a previously piloted low-cost, co-designed intervention to strengthen caregiver support, enhance income generation and promote child play. We hope this could reduce multimorbidity in the caregiver-child pair and improve child convalescence and neurodevelopment
• Combined – Children in this arm will receive a combination of all interventions

Study participants will then be followed up at 24 weeks. The primary outcome is a composite of death or hospitalisation or failed nutritional recovery by 24 weeks post-randomisation.