title: Randomized controlled trial of oxygen saturation targets in very preterm infants: two year outcomes.
abstract: 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.
  
  
  METHODS
  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.
authors.affiliation: Department of Pediatrics, University of Otago, Christchurch, New Zealand. Electronic address: brian.darlow@otago.ac.nz.
authors.forename: Brian A
authors.initials: BA
authors.lastname: Darlow
authors.affiliation: National Heath and Medical Research Council Clinical Trials Center, University of Sydney, Sydney, Australia.
authors.forename: Simone L
authors.initials: SL
authors.lastname: Marschner
authors.affiliation: National Heath and Medical Research Council Clinical Trials Center, University of Sydney, Sydney, Australia.
authors.forename: Mark
authors.initials: M
authors.lastname: Donoghoe
authors.affiliation: Newborn Services, Auckland City Hospital, Auckland, New Zealand.
authors.forename: Malcolm R
authors.initials: MR
authors.lastname: Battin
authors.affiliation: Women's and Children's Health, University of Otago, Dunedin, New Zealand.
authors.forename: Roland S
authors.initials: RS
authors.lastname: Broadbent
authors.affiliation: Academic Department of Surgery, University of Otago, Christchurch, New Zealand.
authors.forename: Mark J
authors.initials: MJ
authors.lastname: Elder
authors.affiliation: Neonatal Intensive Care Unit, Wellington Regional Hospital, Wellington South, New Zealand.
authors.forename: Michael P
authors.initials: MP
authors.lastname: Hewson
authors.affiliation: KidzFirst, Middlemore Hospital, Otahuhu, Auckland, New Zealand.
authors.forename: Michael P
authors.initials: MP
authors.lastname: Meyer
authors.affiliation: National Heath and Medical Research Council Clinical Trials Center, University of Sydney, Sydney, Australia.
authors.forename: Alpana
authors.initials: A
authors.lastname: Ghadge
authors.affiliation: Department of Pediatrics, University of Otago, Christchurch, New Zealand.
authors.forename: Patricia
authors.initials: P
authors.lastname: Graham
authors.affiliation: Department of Pediatrics, University of Otago, Christchurch, New Zealand.
authors.forename: Nicolette J
authors.initials: NJ
authors.lastname: McNeill
authors.affiliation: Newborn Services, Auckland City Hospital, Auckland, New Zealand; Neonatal Services, The Royal Women's Hospital, Melbourne, Victoria, Australia.
authors.forename: Carl A
authors.initials: CA
authors.lastname: Kuschel
authors.affiliation: WINNER Center for Newborn Research, National Health and Medical Research Council Clinical Trials Center, University of Sydney, Sydney, Australia.
authors.forename: William O
authors.initials: WO
authors.lastname: Tarnow-Mordi
mesh_terms: D001315:Australia; D002675:Child, Preschool; D004185:Disability Evaluation; D004311:Double-Blind Method; D005260:Female; D005865:Gestational Age; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D007234:Infant, Premature; D007235:Infant, Premature, Diseases / Q000378:metabolism* / Q000401:mortality / Q000628:therapy; D019102:Infant, Very Low Birth Weight / Q000378:metabolism*; D008297:Male; D017063:Outcome Assessment, Health Care; D010100:Oxygen / Q000097:blood*; D010102:Oxygen Inhalation Therapy / Q000379:methods*; D018570:Risk Assessment
chemical_list: D010100:Oxygen