Conducting Research on Moderate Acute Malnutrition in Humanitarian Emergencies Integrated Management of MAM and SAM in Sierra Leone With Ready to Use Theraputic Foods (RUTF)

Specific Aim 1: Implement an integrated protocol in Sierra Leone for the management of MAM and non-complicated SAM that uses a single anthropometric indicator as well as the same food. Standard care refers to traditional, segregated treatment of MAM and SAM.

Hypothesis: An integrated management protocol for MAM and SAM will achieve greater community coverage and a greater individual recovery rate than standard care.

Methods Eligible subjects will be children with MAM or non-complicated SAM aged 6-59 months. MAM is defined as MUAC < 12.5 cm, but ≥ 11.5 cm. Non-complicated SAM will be defined as MUAC < 11.5 cm, or + or ++ bilateral edema, and having an acceptable appetite. An acceptable appetite will be judged by giving the child 30 g of RUTF and asking the mother to feed this food to the child over 20 minutes. Children with SAM who are able to consume this RUTF will be eligible for the study. Children unable to consume the RUTF or presenting with IMCI warning signs (convulsions, altered mental status, respiratory distress) will be considered to have complicated SAM and will be referred for inpatient treatment. Only the youngest child with malnutrition in each household will be enrolled; older siblings will be treated operationally using the same protocol. Exclusion criteria include children with obvious chronic debilitating illness like cerebral palsy or congenital abnormalities, or having received treatment for MAM or SAM in the previous two months. If any child needs immediate medical care s/he will be offered treatment or transport to the nearest health center, and not enrolled.

Informed consent will be sought from the caretakers of all eligible children by a nurse familiar with the study and fluent in the caretaker's native language. Duration of the study and participation requirements will be explained. Informed consent will be given verbally and in writing.

Study design This is a cluster randomized, unblinded, clinical controlled trial conducted in children comparing integrated treatment of SAM and MAM with standard treatment. The primary outcomes will be treatment coverage and recovery rate. The very obvious differences in integrated and standard care makes subject and staff blinding impossible.