The children's oxygen administration strategies trial

Document Type

Article

Department

Paediatrics and Child Health (East Africa)

Abstract

Background: The life-saving role of oxygen therapy in children with clinically-defined severe pneumonia is not yet established. We hypothesised liberal oxygenation strategies and/or respiratory support may improve the high in-hospital mortality.

Methods: The open-label fractional-factorial COAST trial in Ugandan and Kenyan children aged >28 days with feature of severe pneumonia. In stratum A (severe hypoxaemia: SpO2 <80%) children were randomised to high flow nasal therapy (HFNT: OptiFlow™) or low flow oxygen (LFO: standard care). In stratum B (hypoxaemia: SpO2 80-91%) children were randomised to HFNT or LFO (liberal strategies) or control (no immediate oxygen) (ratio 1:1:2). Children with cyanotic heart disease, chronic lung disease or >3hours receipt of oxygen were excluded. The primary endpoint was 48-hour mortality; secondary endpoints included mortality or neurocognitive sequelae at 28 days.

Findings: The Trial Steering Committee recommended halting recruitment for feasibility after 1842/4200 (44%) children enrolled. Of 1852 recruited, 388 in stratum A (median 7 months; median age SpO2 75%) were randomised to HFNT (n=194) or LFO (n=194) and 1454 in stratum B (median 9 months; median SpO2 88%) were randomised to HFNT (n=363) vs LFO (n=364) vs control (n=727). Per-protocol 109/726(15%) of controls received oxygen (when SpO2 <80%). In stratum A, 48-hour mortality was 9.3% (18/388) for HFNT vs. 13.4% (26/194) for LFO groups. In stratum B 48-mortality was 1.1% (4/363) for HFNT vs. 2.5% (9/364) LFO and 1.4% (10/727) for controls. In stratum B, adjusted (a)odds ratio (aOR) for 48-hour 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). Respective strata-specific 28-day mortality rates were: 18.6%(HFNT) versus 23.4%(LFO) and 3.3%(HFNT) versus 4.1%(LFO) versus 3.9%(control). Neurocognitive sequelae, assessed using Kilifi Neurodevelopmental Index, were rare in all groups.

Interpretation: Conservative oxygen strategies appear safe and respiratory support with HFNT showing potential benefit should prompt further trials.

Comments

This work was published before the author joined Aga Khan University.

Publication (Name of Journal)

Elsevier

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