Supplementation with Ready-to-Use Therapeutic Food has no effect on adverse outcomes among undernourished children aged 6-59 months with severe pneumonia

Damalie Nalwanga^1,2Elisa Giallongo³Victor Musiime^4,5Sarah Kiguli⁴Peter Olupot-Olupot⁶Florence Alaroker⁷Robert Opoka^4,8Tagoola Abner Vesuvius⁹Mainga Hamaluba¹⁰Christabel Mogaka¹⁰Eva Nabawanuka⁴Charles Karamagi^11,4André Briend^12,13Kathryn Maitland^10,14*

• ¹College of Health Sciences, Makerere University, Kampala, Uganda
• ²Lung Institute, College of Health Sciences, Makerere University, Kampala, Uganda
• ³Intensive Care National Audit & Research Centre, London, United Kingdom
• ⁴Department of Paediatrics and Child Health, School of Medicine, College of Health Sciences, Makerere University, Kampala, Uganda
• ⁵Joint Clinical Research Centre, Kampala, Uganda
• ⁶Mbale Clinical Research Institute, Mbale, Uganda, Mbale, Uganda
• ⁷Soroti Regional Referral Hospital, Soroti, Uganda
• ⁸Aga Khan University, Medical College East Africa, Nairobi, Kenya
• ⁹Jinja Regional Referral Hospital, Jinja, Uganda
• ¹⁰KEMRI Wellcome Trust Research Programme, Kilifi, Kenya
• ¹¹Clinical Epidemiology Unit, Department of Internal Medicine, School of Medicine, College of Health Sciences, Makerere University, Kampala, Uganda
• ¹²Tampere Center for Child, Adolescent and Maternal Health Research, Faculty of Medicine and Health Technology, Tampere University and Tampere University Hospital, Tampere, Finland
• ¹³Department of Nutrition, Exercise and Sports, Faculty of Science, University of Copenhagen, Frederiksberg, Denmark
• ¹⁴Department of Infectious Disease and Institute of Global Health and Innovation, Imperial College London, London, United Kingdom

Objectives: To investigate the effect of supplementation with ready-to-use therapeutic food (RUTF) on adverse outcomes among undernourished children aged 6 -59 months with severe pneumonia.This secondary analysis of the COAST-Nutrition (ISRCTN10829073) included children hospitalized for severe pneumonia in Uganda and Kenya. Undernutrition was defined as having either a weight-for-age z score, height-for-age z score, or weight-for-height/length z score below the median of the WHO reference population (< 0) or mid-upper arm circumference (MUAC) below 13.5 cm. Participants were randomized to receive 1 sachet of RUTF daily for 8 weeks in addition to the usual diet (intervention) or usual diet alone (control). The primary composite outcome for adverse events was any one of mortality, re-admission, or deterioration of nutritional status by day 90 of follow-up.Of 846 main trial participants, 741 (88%) met the inclusion criteria (intervention:374 versus control:367). Of 687 (93%) participants in whom the primary outcome was assessed, 370 (54%) experienced an adverse event, (intervention: 184/348(53%) versus control: 186/339(54%). There was no difference in the primary outcome between groups, aOR 0.92 (95% CI 0.68, 1.24), p= 0.572. Adverse outcome risk reduced with increasing age, aOR 0.53, (95% CI 0.45, 0.62), p<0.001.RUTF supplementation did not reduce the high frequency of adverse outcomes in children aged 6-59 months following hospital admission with severe pneumonia. Nutritional support directly targeting metabolic needs post-pneumonia should be considered in the future.