Nutrition and Dietetics Department, Faculty of Public Health, Jimma University, Jimma, Ethiopia.
Center for Food Science and Nutrition, Addis Ababa University, Addis Ababa, Ethiopia.
Matern Child Nutr. 2024 Oct;20(4):e13670. doi: 10.1111/mcn.13670. Epub 2024 May 27.
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.
全球范围内，2022 年有近 4500 万名 5 岁以下儿童受到消瘦的影响。埃塞俄比亚一直面临着灾害的挑战，导致消瘦儿童的病例数增加。本研究旨在确定简化方法对急性营养不良儿童康复的效果，与标准方案相比。一项在埃塞俄比亚三个地区进行的集群随机、对照、非劣效性试验于 2021 年 12 月 4 日至 2022 年 7 月 30 日进行。共有 58 个集群（卫生所）随机分为干预组和对照组。干预组中患有严重急性营养不良的儿童接受两袋即食治疗食品（RUTF），而对照组中的儿童则根据体重接受 RUTF。干预和对照组中患有中度急性营养不良的儿童每天分别接受一袋 RUTF 和一袋即食补充食品（RUSF）。使用符合方案（PP）和意向治疗（ITT）分析来比较在非劣效性边界 15%的恢复情况。数据来自 55 个卫生所和 1032 名儿童。在 PP 分析中，简化组消瘦儿童的恢复率（97.8%）与标准方案组（97.7%）相当，p=0.399。每治疗一名患有 SAM 的儿童的 RUTF 成本，标准方案为 56.55 美元，简化方案为 42.78 美元。简化方法在恢复方面不劣于标准方案，且 RUTF 成本更低。建议进一步研究评估简化方法在紧急情况下的有效性。
