Randomized controlled trial of oxygen saturation targets in very preterm infants: two year outcomes

J Pediatr. 2014 Jul;165(1):30-35.e2. doi: 10.1016/j.jpeds.2014.01.017. Epub 2014 Feb 20.


Objective: To assess whether an oxygen saturation (Spo2) target of 85%-89% compared with 91%-95% reduced the incidence of the composite outcome of death or major disability at 2 years of age in infants born at <28 weeks' gestation.

Study design: A total 340 infants were randomized to a lower or higher target from <24 hours of age until 36 weeks' gestational age. Blinding was achieved by targeting a displayed Spo2 of 88%-92% using a saturation monitor offset by ±3% within the range 85%-95%. True saturations were displayed outside this range. Follow-up at 2 years' corrected age was by pediatric examination and formal neurodevelopmental assessment. Major disability was gross motor disability, cognitive or language delay, severe hearing loss, or blindness.

Results: The primary outcome was known for 335 infants with 33 using surrogate language information. Targeting a lower compared with a higher Spo2 target range had no significant effect on the rate of death or major disability at 2 years' corrected age (65/167 [38.9%] vs 76/168 [45.2%]; relative risk 1.15, 95% CI 0.90-1.47) or any secondary outcomes. Death occurred in 25 (14.7%) and 27 (15.9%) of those randomized to the lower and higher target, respectively, and blindness in 0% and 0.7%.

Conclusions: Although there was no benefit or harm from targeting a lower compared with a higher saturation in this trial, further information will become available from the prospectively planned meta-analysis of this and 4 other trials comprising a total of nearly 5000 infants.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Australia
  • Child, Preschool
  • Disability Evaluation
  • Double-Blind Method
  • Female
  • Gestational Age
  • Humans
  • Infant
  • Infant, Newborn
  • Infant, Premature*
  • Infant, Premature, Diseases / metabolism*
  • Infant, Premature, Diseases / mortality
  • Infant, Premature, Diseases / therapy
  • Infant, Very Low Birth Weight / metabolism*
  • Male
  • Outcome Assessment, Health Care
  • Oxygen / blood*
  • Oxygen Inhalation Therapy / methods*
  • Risk Assessment


  • Oxygen