Supplemental oxygen did not reduce progression of pre-threshold retinopathy of prematurity in infants
QUESTION: In premature infants, is supplemental oxygen at pulse oximetry saturations of 96% to 99% more effective than conventional oxygen at pulse oximetry saturations of 89% to 94% in reducing the progression from moderate (pre-threshold) to threshold retinopathy of prematurity (ROP)?
Design
Randomised (allocation concealed), blinded (outcome assessor), controlled trial with 3 months of follow up.
Setting
71 hospitals affiliated with 30 centres in the US.
Patients
649 infants (mean gestational age 25 wks, 57% boys, 55% white) who were born prematurely, had pre-threshold ROP in ≥1 eye, and had a median pulse oximetry ≤94% oxygen saturation in room air. Infants were excluded if they had lethal anomalies or congenital anomalies of the eye. Follow up was 92%.
Intervention
After stratification by study centre and 2 levels of baseline ROP severity, infants were randomised to receive supplemental oxygen therapy with pulse oximetry targeted at 96% to 99% oxygen …
