Randomised controlled trial of oxygen therapy and high-flow nasal therapy in African children with pneumonia.
Maitland K., Kiguli S., Olupot-Olupot P., Hamaluba M., Thomas K., Alaroker F., Opoka RO., Tagoola A., Bandika V., Mpoya A., Mnjella H., Nabawanuka E., Okiror W., Nakuya M., Aromut D., Engoru C., Oguda E., Williams TN., Fraser JF., Harrison DA., Rowan K., COAST trial group None.
PurposeThe life-saving role of oxygen therapy in African children with severe pneumonia is not yet established.MethodsThe open-label fractional-factorial COAST trial randomised eligible Ugandan and Kenyan children aged > 28 days with severe pneumonia and severe hypoxaemia stratum (SpO2 2 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.ResultsThe 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 ConclusionsRespiratory support with HFNT showing potential benefit should prompt further trials.