An adaptive multiarm randomised trial of biomedical and psychosocial interventions to improve convalescence following severe acute malnutrition in sub-Saharan Africa: Co-SAM trial protocol

作者：Mutsa Bwakura‐Dangarembizi, Beatrice Amadi, Benson Singa, Sofia Muyemayema, Deophine Ngosa, Laura Mwalekwa, Narshion Ngao, Lydia Kazhila, Batsirai Mutasa, Eddington Mpofu, Louisa Mudawarima, Gerard Bryan Gonzales, Shepherd Mudzingwa, Mukumbi Mutenda, Lucia Keter, Kuda Mutasa, James M. Njunge, Helen Jones, Tracy N. Phiri, Evans Mudibo, Nivea Chulu, Florence D. Majo, Bernard Chasekwa, Aaron Tembo, Churchil Nyabinda, Chris Oduol, Virginia Sauramba, Naume V. Tavengwa, Lisa Langhaug, Isabella Cordani, Melanie Smuk, Thomas Jaki, Robert Ntozini, Judd L. Walson, Kirkby D. Tickell, James A. Berkley, Paul Kelly, Andrew J. Prendergast · 发表于：BMJ Open · 年份：2025 · DOI：10.1136/bmjopen-2024-093758 · 被引用次数：3 · 研究领域：Child Nutrition and Water Access、Child Nutrition and Feeding Issues、Clinical Nutrition and Gastroenterology

INTRODUCTION: Children discharged from hospital following management of complicated severe acute malnutrition (SAM) have a high risk of mortality, readmission and failed nutritional recovery. Current management approaches fail to sufficiently promote convalescence after inpatient nutritional rehabilitation. Novel interventions during the post-discharge period could enhance convalescence to help children survive and thrive. METHODS AND ANALYSIS: The Co-SAM trial is an adaptive, multicountry, phase III, individually randomised clinical trial, based on the principles that (i) interacting biological and social factors drive multimorbidity in children with SAM, and (ii) both medical and psychosocial interventions may therefore ameliorate underlying causal pathways to reduce morbidity and mortality and improve recovery. Children aged 6-59 months with complicated SAM, who have stabilised and started the transition to ready-to-use therapeutic food (RUTF), will be enrolled and randomised to one of five trial arms (standard-of-care alone; antimicrobials; reformulated RUTF; psychosocial support; or a combination of all strategies). Standard-of-care, which is provided in all trial arms, includes RUTF until nutritional recovery (defined as weight-for-height Z-score >-2, mid-upper arm circumference >12.5 cm and oedema-free since the last study visit), and other management recommended in WHO guidelines. The 12-week antimicrobial package provides daily co-formulated rifampicin and isoniazid ...