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. 2024 May 14:72:102640.
doi: 10.1016/j.eclinm.2024.102640. eCollection 2024 Jun.

Nutritional supplementation in children with severe pneumonia in Uganda and Kenya (COAST-Nutrition): a phase 2 randomised controlled trial

Sarah Kiguli  1 , Peter Olupot-Olupot  2   3 , Mainga Hamaluba  4 , Elisa Giallongo  5 , Karen Thomas  5 , Florence Alaroker  6 , Robert O Opoka  1   7 , Abner Tagoola  7 , Shela Oyella  8 , Damalie Nalwanga  1 , Eva Nabawanuka  1   9 , William Okiror  2   3 , Margaret Nakuya  6 , Denis Amorut  6 , Rita Muhindo  3 , Ayub Mpoya  4 , Hellen Mnjalla  4 , Emmanuel Oguda  4 , Thomas N Williams  4   10 , David A Harrison  5 , Kathy Rowan  5 , Andre Briend  11   12 , Kathryn Maitland  4   10
Affiliations

Nutritional supplementation in children with severe pneumonia in Uganda and Kenya (COAST-Nutrition): a phase 2 randomised controlled trial

Sarah Kiguli et al. EClinicalMedicine. .

Abstract

Background: Severe pneumonia in African children results in poor long-term outcomes (deaths/readmissions) with undernutrition as a key risk factor. We hypothesised additional energy/protein-rich Ready-to-Use Therapeutic Foods (RUTF) would meet additional nutritional requirements and improve outcomes.

Methods: COAST-Nutrition was an open-label Phase 2 randomised controlled trial in children (aged 6 months-12 years) hospitalised with severe pneumonia (and hypoxaemia, SpO2 <92%) in Mbale, Soroti, Jinja, Masaka Regional Referral Hospitals, Uganda and Kilifi County Hospital, Kenya (ISRCTN10829073 (registered 6th June 2018) PACTR202106635355751 (registered 2nd June 2021)). Children were randomised (ratio 1:1) to enhanced nutritional supplementation with RUTF (plus usual diet) for 56 days vs usual diet (control). The primary outcome was change in mid-upper arm circumference (MUAC) at 90 days as a composite with mortality. Secondary outcomes include anthropometric status, mortality, and readmissions at Days 28, 90 and 180.

Findings: Between 12 August 2018 and 22 April 2022, 846 eligible children were randomised, 424 to RUTF and 422 to usual diet, and followed for 180-days [12 (1%) lost-to-follow-up]. RUTF supplement was initiated in 417/419 (>99%). By Day 90, there was no significant difference in the composite endpoint (probabilistic index 0.49, 95% CI 0.45-0.53, p = 0.74). Respective 90-day mortality (13/420 3.1% vs 14/421 3.3%) and MUAC increment (0.54 (SD 0.85) vs 0.55 (SD 0.81)) were similar between arms. There was no difference in any anthropometric secondary endpoints to Day 28, 90 or 180 except skinfold thickness at Day 28 and Day 90 was greater in the RUTF arm. Serious adverse events were higher in the RUTF arm (n = 164 vs 108), mainly due to hospital readmission for acute illness (54/387 (14%) vs 37/375 (10%).

Interpretation: Our study suggested that nutritional supplementation with RUTF did not improve outcomes to 180 days in children with severe pneumonia.

Funding: This trial is part of the EDCTP2 programme (grant number RIA-2016S-1636-COAST-Nutrition) supported by the European Union, and UK Joint Global Health Trials scheme: Medical Research Council, Department for International Development, Wellcome Trust (grant number MR/L004364/1, UK).

Keywords: Africa; Anthropometry; Children; Nutritional support; Pneumonia randomised controlled trial; Ready to use therapeutic feeds.

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Conflict of interest statement

The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
Trial profile.
Fig. 2
Fig. 2
(a) Stacked bar chart illustrating composite primary outcome and (b) Kaplan–Meier plot of all-cause mortality up to day 180.
Fig. 3
Fig. 3
Kaplan–Meier plot of readmissions up to day 180.
See this image and copyright information in PMC

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