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Randomized Controlled Trial
. 2021 May;47(5):566-576.
doi: 10.1007/s00134-021-06385-3. Epub 2021 May 5.

Randomised controlled trial of oxygen therapy and high-flow nasal therapy in African children with pneumonia

K Maitland #  1   2 , S Kiguli #  3 , P Olupot-Olupot #  4 , M Hamaluba #  5 , K Thomas  6 , F Alaroker  7 , R O Opoka  3   8 , A Tagoola  8 , V Bandika  9 , A Mpoya  5 , H Mnjella  5 , E Nabawanuka  3 , W Okiror  4 , M Nakuya  7 , D Aromut  7 , C Engoru  7 , E Oguda  5 , T N Williams  10   5 , J F Fraser  11 , D A Harrison  6 , K Rowan  6 ; COAST trial group
Collaborators, Affiliations
Randomized Controlled Trial

Randomised controlled trial of oxygen therapy and high-flow nasal therapy in African children with pneumonia

K Maitland et al. Intensive Care Med. 2021 May.

Abstract

Purpose: The life-saving role of oxygen therapy in African children with severe pneumonia is not yet established.

Methods: The open-label fractional-factorial COAST trial randomised eligible Ugandan and Kenyan children aged > 28 days with severe pneumonia and severe hypoxaemia stratum (SpO2 < 80%) to high-flow nasal therapy (HFNT) or low-flow oxygen (LFO: standard care) and hypoxaemia stratum (SpO2 80-91%) to HFNT or LFO (liberal strategies) or permissive hypoxaemia (ratio 1:1:2). Children with cyanotic heart disease, chronic lung disease or > 3 h receipt of oxygen were excluded. The primary endpoint was 48 h mortality; secondary endpoints included mortality or neurocognitive sequelae at 28 days.

Results: The trial was stopped early after enrolling 1852/4200 children, including 388 in the severe hypoxaemia stratum (median 7 months; median SpO2 75%) randomised to HFNT (n = 194) or LFO (n = 194) and 1454 in the hypoxaemia stratum (median 9 months; median SpO2 88%) randomised to HFNT (n = 363) vs LFO (n = 364) vs permissive hypoxaemia (n = 727). Per-protocol 15% of patients in the permissive hypoxaemia group received oxygen (when SpO2 < 80%). In the severe hypoxaemia stratum, 48-h mortality was 9.3% for HFNT vs. 13.4% for LFO groups. In the hypoxaemia stratum, 48-h mortality was 1.1% for HFNT vs. 2.5% LFO and 1.4% for permissive hypoxaemia. In the hypoxaemia stratum, adjusted odds ratio for 48-h mortality in liberal vs permissive comparison was 1.16 (0.49-2.74; p = 0.73); HFNT vs LFO comparison was 0.60 (0.33-1.06; p = 0.08). Strata-specific 28 day mortality rates were, respectively: 18.6, 23.4 and 3.3, 4.1, 3.9%. Neurocognitive sequelae were rare.

Conclusions: Respiratory support with HFNT showing potential benefit should prompt further trials.

Keywords: African children; Clinical trial; High-flow nasal therapy; Oxygen; Pneumonia.

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Conflict of interest statement

All authors declare no conflicts of interest.

Figures

Fig. 1
Fig. 1
Asterisk patients were catagorised as absconded if they self-discharged from hospital against medical advice and subsequently lost to follow-up before 28 days. Double asterisk neurocognitive status was available at 90 days for all children known to have neurocognitive deficit at day 28
Fig. 2
Fig. 2
Proportion of children in each stratum receiving oxygen/respiratory support by group over 48- hours post-randomisation
See this image and copyright information in PMC

Comment in

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