An Adaptive Multi-arm Trial to Improve Clinical Outcomes Among Children Recovering From Complicated SAM

Launched by QUEEN MARY UNIVERSITY OF LONDON · Aug 8, 2023

Keywords

ClinConnect Summary

This clinical trial is studying how to improve health outcomes for young children who are recovering from a serious form of malnutrition called complicated severe acute malnutrition (SAM). SAM is a life-threatening condition that affects millions of children worldwide, especially those who also have illnesses like pneumonia, diarrhea, or malaria. The trial aims to find better ways to support these children after they leave the hospital, where they often face challenges in their home environments, such as poverty and social issues. Researchers will test different support programs to see which ones help reduce hospital readmissions and improve nutrition recovery.

To participate in this trial, children must be between 6 and 59 months old and have been hospitalized for complicated SAM. It’s important that their caregivers are willing and able to bring them to the study clinic for all visits and can provide consent for their participation. Throughout the trial, caregivers and children will receive special support as researchers gather information on how effective these new approaches are in helping the children recover and stay healthy.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age 6-59 months, of either sex
• • Hospitalised with complicated severe acute malnutrition, as per WHO definition
• • Started transition to RUTF
• • Caregiver willing and able to attend the study clinic for all visits
• • Caregiver able and willing to give informed consent
• Exclusion Criteria:
• • Any acute or chronic condition which mean that receipt of one or more study interventions, or participation in the trial, would not be advisable.