Maru Yetayesh, Tamiru Dessalegn, Baye Kaleab, Chitekwe Stanley, Kifle Yehenew G, Lailou Arnaud, Belachew Tefera
Nurition and Dietetics Department, Faculty of Public Health, Jimma University, Jimma, Ethiopia.
Center for Food Science and Nutrition, Addis Ababa University, Addis Ababa, Ethiopia.
Front Pediatr. 2024 May 22;12:1337370. doi: 10.3389/fped.2024.1337370. eCollection 2024.
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.
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.
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 ( = 0.13). For MAM cases, the average length of stay was 8.18 (±2.96) weeks for the simplified approach and 8.32 (±3.55) weeks for the standard protocol ( = 0.61). There was no significant difference ( = 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 ( = 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 ( > 0.5), indicating the non-inferiority of the simplified approach for cure time.
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.
https://pactr.samrc.ac.za/, Identifier (PACTR202202496481398).
当身体因摄入不足或疾病而营养需求未得到满足时，就会出现消瘦。这是一项重大的全球挑战，2022年约有4500万5岁以下婴幼儿患有消瘦症。
在埃塞俄比亚的三个地区进行了一项整群随机对照非劣效性试验。在确定1052名儿童的总样本量时，考虑了15%的非劣效性界值、90%的恢复率和75%的最低可接受恢复率，以及0.05的组内相关系数和10%的预期失访率。简化组中患有重度急性营养不良（SAM）的儿童每天接受两包即食治疗性食品（RUTF），而标准组则根据其体重接受RUTF。对于中度急性营养不良（MAM）病例，简化组接受一包RUTF，而标准组每天接受一包即食补充食品。使用非参数Kaplan-Meir曲线比较恢复的生存时间。
共收集了1032个数据点。对于SAM病例，简化方案的平均住院时间为8.86（±3.91）周，标准方案为8.26（±4.18）周（=0.13）。对于MAM病例，简化方法的平均住院时间为8.18（±2.96）周，标准方案为8.32（±3.55）周（=0.61）。在SAM儿童中，简化方案[8周，四分位间距（IQR）：7.06 - 8.94]和标准方案[9周（IQR：8.17 - 9.83）]在治愈中位时间上没有显著差异（=0.502）。在MAM儿童中，简化方法[8周（IQR：7.53 - 8.47）]和标准方案[8周（IQR：7.66 - 8.34）]在治愈时间上没有显著差异（=0.502）。生存曲线显示出相似性，对数秩检验未显示出显著性（>0.5），表明简化方法在治愈时间方面具有非劣效性。
研究结果表明，简化方案和标准方案在平均住院时间和恢复所需时间方面没有显著差异。
