Children’s Oxygen Administration Strategies And Nutrition Trial (COAST-Nutrition): a protocol for a phase II randomised controlled trial

Wellcome Open Research

article

Eva Nabawanuka¹  James Nokes²  Charles Nyaigoti²  André Briend³  Job B. M. van Woensel⁴  Richard Grieve⁵  Zia Sadique⁵  Thomas N. Williams²  Karen Thomas⁷  David A. Harrison⁷  Kathryn Rowan⁷  Kathryn Maitland²  Sarah Kiguli¹  Peter Olopot-Olupot⁸  Florence Alaroker⁹  Charles Engoru⁹  Robert O. Opoka¹  Abner Tagoola^1,10  Mainga Hamaluba^1,11  Hellen Mnjalla²  Ayub Mpoya²  Christabel Mogaka²  Damalie Nalwanga¹ 

[1] Paediatrics, Makerere University;KEMRI Wellcome TRust Research Programme;School of Medicine, University of Tampere;Paediatric Intensive Care Unit, Emma Children’s Hospital and Academic Medical Center;Centre for Statistical Methodology, London School of Hygiene & Tropical Medicine;Department of Infectious Disease and Institute of Global Health and Innovation, Imperial College London;Intensive Care National Audit;Paediatrics, Mbale Regional Referral Hospital;Paediatrics, Soroti Regional Referral Hospital;Paediatrics, Jinja Regional Referral Hospital;Paediatrics, Kilifi County Hospital

关键词: Children;    Africa;    Pneumonia;    Randomised controlled trial;    nutritional support;    Ready to use Therapeutic Feeds;    anthropometry;    pathogen diagnosis;   

DOI  :  10.12688/wellcomeopenres.17123.2

学科分类：内科医学

来源: Wellcome

【 摘 要 】

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, SpO2 <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.

【 授权许可】

CC BY