Children's Oxygen Administration Strategies And Nutrition Trial (COAST-Nutrition): a protocol for a phase II randomised controlled trial.
Children's Oxygen Administration Strategies And Nutrition Trial (COAST-Nutrition): a protocol for a phase II randomised controlled trial.
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DOI：
10.12688/wellcomeopenres.17123.2
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发表时间：
2021
影响因子：
--
通讯作者：
Maitland K
中科院分区：
文献类型：
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作者：
Kiguli S;Olopot-Olupot P;Alaroker F;Engoru C;Opoka RO;Tagoola A;Hamaluba M;Mnjalla H;Mpoya A;Mogaka C;Nalwanga D;Nabawanuka E;Nokes J;Nyaigoti C;Briend A;van Woensel JBM;Grieve R;Sadique Z;Williams TN;Thomas K;Harrison DA;Rowan K;Maitland K
背景：为了防止不良的长期结果（死亡和再入院），肺炎和腹泻综合全球行动计划在保护、预防和治疗干预措施的“治疗”要素下建议继续喂养的重要性，但没有给出营养支持的具体建议。早期营养支持已在多种危重患者中得到实践，以提供正常细胞功能和减少代谢亢进所必需的重要细胞底物、抗氧化剂、维生素和矿物质。我们假设与肺炎相关的出院后死亡率过高可能与严重感染引起的分解代谢反应和肌肉萎缩以及饮食不足以帮助康复有关。我们建议提供额外的富含能量、蛋白质、脂肪和微量营养素的即用型治疗饲料 (RUTF) 来帮助满足额外的营养需求，可能会改善结果。 方法：COAST-Nuttion 是一项开放、多中心、II 期随机对照试验，受试者为疑似严重肺炎（和低氧血症，SpO 2 <92%）住院的 6 个月至 12 岁儿童，旨在确定与单独使用常规饮食（对照）相比，在常规饮食之外添加 RUTF 补充饲料 56 天（实验）是否可以改善 90 天的结果。主要终点是 90 天时中上臂围 (MUAC) 的变化和/或与 90 天死亡率的综合变化。次要结局包括人体测量状况、死亡率、第 28 天和第 180 天的再入院。该试验将在两个国家（乌干达和肯尼亚）的四个地点进行，招募 840 名儿童，随访长达 180 天。辅助研究包括成本经济分析、细菌和病毒病原体的分子特征、肺炎假定生物标志物的评估、肌肉和脂肪量的评估以及宿主遗传学研究。 讨论：这项研究是为严重肺炎后提供营养支持选择的第一步，并将有助于设计大型 III 期试验。 注册：ISRCTN10829073（2018年6月6日）PACTR202106635355751（2021年6月2日）
Background: To prevent poor long-term outcomes (deaths and readmissions) the integrated global action plan for pneumonia and diarrhoea recommends under the ‘Treat’ element of Protect, Prevent and Treat interventions the importance of continued feeding but gives no specific recommendations for nutritional support. Early nutritional support has been practiced in a wide variety of critically ill patients to provide vital cell substrates, antioxidants, vitamins, and minerals essential for normal cell function and decreasing hypermetabolism. We hypothesise that the excess post-discharge mortality associated with pneumonia may relate to the catabolic response and muscle wasting induced by severe infection and inadequacy of the diet to aid recovery. We suggest that providing additional energy-rich, protein, fat and micronutrient ready-to-use therapeutic feeds (RUTF) to help meet additional nutritional requirements may improve outcome. Methods: COAST-Nutrition is an open, multicentre, Phase II randomised controlled trial in children aged 6 months to 12 years hospitalised with suspected severe pneumonia (and hypoxaemia, SpO 2 <92%) to establish whether supplementary feeds with RUTF given in addition to usual diet for 56-days (experimental) improves outcomes at 90-days compared to usual diet alone (control). Primary endpoint is change in mid-upper arm circumference (MUAC) at 90 days and/or as a composite with 90-day mortality. Secondary outcomes include anthropometric status, mortality, readmission at days 28 and 180. The trial will be conducted in four sites in two countries (Uganda and Kenya) enrolling 840 children followed up to 180 days. Ancillary studies include cost-economic analysis, molecular characterisation of bacterial and viral pathogens, evaluation of putative biomarkers of pneumonia, assessment of muscle and fat mass and host genetic studies. Discussion: This study is the first step in providing an option for nutritional support following severe pneumonia and will help in the design of a large Phase III trial. Registration: ISRCTN10829073 (6 th June 2018) PACTR202106635355751 (2 nd June 2021)