RESUMO
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.
RESUMO
Introduction: Wasting occurs when the body's nutritional needs are unmet due to insufficient intake or illness. It represents a significant global challenge, with approximately 45 million infants and children under 5 years of age suffering from wasting in 2022. Methods: A cluster-randomized, controlled, non-inferiority trial was conducted in three regions of Ethiopia. A non-inferiority margin of 15%, along with a recovery rate of 90% and a minimum acceptable recovery rate of 75%, were considered alongside an intra-cluster correlation coefficient of 0.05 and an anticipated loss to follow-up of 10% in determining the total sample size of 1,052 children. Children with severe acute malnutrition (SAM) in the simplified group received two sachets of ready-to-use therapeutic food (RUTF) daily, while the standard group received RUTF based on their body weight. For moderate acute malnutrition (MAM) cases, the simplified group received one sachet of RUTF, whereas the standard group received one sachet of ready-to-use supplementary food daily. A non-parametric Kaplan-Meir curve was utilized to compare the survival time to recovery. Results: A total of 1,032 data points were gathered. For SAM cases, the average length of stay was 8.86 (±3.91) weeks for the simplified protocol and 8.26 (±4.18) weeks for the standard protocol (P = 0.13). For MAM cases, the average length of stay was 8.18 (±2.96)â weeks for the simplified approach and 8.32 (±3.55)â weeks for the standard protocol (P = 0.61). There was no significant difference (P = 0.502) observed between the simplified protocol [8 weeks, interquartile range (IQR): 7.06-8.94] and the standard protocol [9 weeks (IQR: 8.17-9.83)] among children with SAM on the median time to cure. There was no significant difference (P = 0.502) in the time to cure between the simplified approach [8 weeks (IQR: 7.53-8.47)] and the standard protocol [8 weeks (IQR: 7.66-8.34)] among children with MAM. The survival curves displayed similarity, with the log-rank test not showing significance (P > 0.5), indicating the non-inferiority of the simplified approach for cure time. Conclusion: The findings showed that the simplified and standard protocols demonstrated no significant differences in terms of the average duration of stay and time required for recovery. Clinical Trial Registration: https://pactr.samrc.ac.za/, Identifier (PACTR202202496481398).