Effect of a simplified approach on recovery of children 6-59 months with wasting in Ethiopia: A noninferiority, cluster randomized controlled trial.

Worldwide, nearly 45 million children under the age of 5 years were affected by wasting in 2022. Ethiopia has been challenged by disasters increasing the caseload of children with wasting. This study aimed to determine the effect of a simplified approach on recovery of children with acute malnutrition as compared with the standard protocol. A cluster randomized, controlled, noninferiority trial was carried out in three regions of Ethiopia from December 4, 2021, to July 30, 2022. A total of 58 clusters (health posts) were randomized into intervention and control groups. Children with SAM in the intervention groups received two sachets of Ready-to-Use Therapeutic Food (RUTF), whereas children in the control groups received RUTF based on their body weight. Children with moderate acute malnutrition (MAM) received one sachet of RUTF and one sachet of Ready-to-Use Supplementary Food (RUSF) daily in the intervention and control groups, respectively. Per protocol (PP) and intention-to-treat analysis were used to compare recovery at a noninferiority margin of 15%. Data were collected from 55 health posts and 1032 children. In the PP analysis, the recovery rate of children with wasting among the simplified group (97.8%) was noninferior to the standard protocol group (97.7%), p = 0.399. The RUTF cost per treatment of child with SAM was 56.55 USD for the standard versus 42.78 USD for the simplified approach. The simplified approach is noninferior to the standard protocol in terms of recovery and has a lower cost of RUTF. Further study is recommended to assess the effectiveness of the simplified approach in emergency contexts.