BPD saturation trial
Supplemental Oxygen Strategies in children with BronchoPulmonary Dysplasia (SOS BPD)
Paziente / Popolazione Intervento / Esposizione Confronto Esito
In 201 preterm infants with moderate or severe bronchopulmonary dysplasia, an oxygen saturation lower limit of 95% for weaning supplemental oxygen did not improve weight standard deviation score at 6 months corrected age compared with an oxygen saturation lower limit of 90%.
Disegno
Pragmatic, non-blinded, multicentre, parallel-group superiority randomised trial in 30 Dutch hospitals (SOS BPD); preterm infants with moderate or severe bronchopulmonary dysplasia randomised between 36 and 38 weeks postmenstrual age to weaning of supplemental oxygen and respiratory support at an SpO2 lower limit of 95% (99 infants) or 90% (102 infants), kept until respiratory support was successfully stopped
Esito
Weight standard deviation score at 6 months corrected age, as a surrogate for lung growth; 24 prespecified secondary outcomes to 6 months corrected age
RisultatoWeight standard deviation score at 6 months corrected age -0.9 (SD 1.2) with the 95% limit vs -0.8 (SD 1.2) with the 90% limit (mean difference -0.16, 95% CI -0.46 to 0.13). Infants held at 95% stayed on respiratory support longer (median 41.0 vs 31.5 days, hazard ratio 0.60, 95% CI 0.44 to 0.81) and came off it later (median 42.9 vs 41.1 weeks postmenstrual age, median difference 2.6 weeks, 95% CI 1.4 to 4.0). None of the other 24 prespecified secondary outcomes differed. 99 infants were assigned the 95% limit and 102 the 90% limit, mean gestational age 27 weeks.
de Ridder R, Balink S, Onland W, et al. Presented at ERS Congress 2026, ALERT 2, 8 September. Not yet published.
Discussione e critica
Holding preterm infants with established bronchopulmonary dysplasia above 95% saturation did not grow them better than holding them above 90%, and it kept them on respiratory support some ten days longer. The trial asks what the birth-cohort saturation trials left open, after 36 weeks rather than before, and the answer runs against the instinct to give more oxygen for longer. The primary outcome is weight as a proxy for lung growth, a surrogate for a surrogate, and the neurodevelopmental and lung function follow-up is still to come. Two hundred infants across 30 Dutch hospitals leaves room for a small benefit inside the interval, but none of the 24 secondary outcomes points that way.