Supplementation with ready-to-use therapeutic food has no effect on adverse outcomes among undernourished children aged 6–59 months with severe pneumonia

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. Methods: 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. Results: 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. Conclusion: 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. Clinical trial registration: ISRCTN10829073, PACTR202106635355751.