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Supplemental oxygen did not reduce progression of pre-threshold retinopathy of prematurity in infants

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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)?


Randomised (allocation concealed), blinded (outcome assessor), controlled trial with 3 months of follow up.


71 hospitals affiliated with 30 centres in the US.


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%.


After stratification by study centre and 2 levels …

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  • Sources of funding: National Institute of Child Health and Human Development; National Institute of Nursing Research; National Institutes of Health; Delta Gamma Sorority; Rhea and Raymond White Donation; Research to Prevent Blindness; Chartwell Home Therapy; Ohmeda Corporation.

  • For correspondence: Dr D L Phelps, Children's Hospital at Strong, University of Rochester School of Medicine and Dentistry, Pediatrics, Box 651, 601 Elmwood Avenue, Rochester, NY 14642, USA. Fax +1 716 461 3614.

  • * p Value calculated from data in article.