title: Target ranges of oxygen saturation in extremely preterm infants.
abstract: BACKGROUND
  Previous studies have suggested that the incidence of retinopathy is lower in preterm infants with exposure to reduced levels of oxygenation than in those exposed to higher levels of oxygenation. However, it is unclear what range of oxygen saturation is appropriate to minimize retinopathy without increasing adverse outcomes.
  
  
  METHODS
  We performed a randomized trial with a 2-by-2 factorial design to compare target ranges of oxygen saturation of 85 to 89% or 91 to 95% among 1316 infants who were born between 24 weeks 0 days and 27 weeks 6 days of gestation. The primary outcome was a composite of severe retinopathy of prematurity (defined as the presence of threshold retinopathy, the need for surgical ophthalmologic intervention, or the use of bevacizumab), death before discharge from the hospital, or both. All infants were also randomly assigned to continuous positive airway pressure or intubation and surfactant.
  
  
  RESULTS
  The rates of severe retinopathy or death did not differ significantly between the lower-oxygen-saturation group and the higher-oxygen-saturation group (28.3% and 32.1%, respectively; relative risk with lower oxygen saturation, 0.90; 95% confidence interval [CI], 0.76 to 1.06; P=0.21). Death before discharge occurred more frequently in the lower-oxygen-saturation group (in 19.9% of infants vs. 16.2%; relative risk, 1.27; 95% CI, 1.01 to 1.60; P=0.04), whereas severe retinopathy among survivors occurred less often in this group (8.6% vs. 17.9%; relative risk, 0.52; 95% CI, 0.37 to 0.73; P<0.001). There were no significant differences in the rates of other adverse events.
  
  
  CONCLUSIONS
  A lower target range of oxygenation (85 to 89%), as compared with a higher range (91 to 95%), did not significantly decrease the composite outcome of severe retinopathy or death, but it resulted in an increase in mortality and a substantial decrease in severe retinopathy among survivors. The increase in mortality is a major concern, since a lower target range of oxygen saturation is increasingly being advocated to prevent retinopathy of prematurity. (ClinicalTrials.gov number, NCT00233324.)
authors.forename: Waldemar A
authors.initials: WA
authors.lastname: Carlo
authors.forename: Neil N
authors.initials: NN
authors.lastname: Finer
authors.forename: Michele C
authors.initials: MC
authors.lastname: Walsh
authors.forename: Wade
authors.initials: W
authors.lastname: Rich
authors.forename: Marie G
authors.initials: MG
authors.lastname: Gantz
authors.forename: Abbot R
authors.initials: AR
authors.lastname: Laptook
authors.forename: Bradley A
authors.initials: BA
authors.lastname: Yoder
authors.forename: Roger G
authors.initials: RG
authors.lastname: Faix
authors.forename: Abhik
authors.initials: A
authors.lastname: Das
authors.forename: W Kenneth
authors.initials: WK
authors.lastname: Poole
authors.forename: Kurt
authors.initials: K
authors.lastname: Schibler
authors.forename: Nancy S
authors.initials: NS
authors.lastname: Newman
authors.forename: Namasivayam
authors.initials: N
authors.lastname: Ambalavanan
authors.forename: Ivan D
authors.initials: ID
authors.lastname: Frantz
authors.forename: Anthony J
authors.initials: AJ
authors.lastname: Piazza
authors.forename: Pablo J
authors.initials: PJ
authors.lastname: Sánchez
authors.forename: Brenda H
authors.initials: BH
authors.lastname: Morris
authors.forename: Nirupama
authors.initials: N
authors.lastname: Laroia
authors.forename: Dale L
authors.initials: DL
authors.lastname: Phelps
authors.forename: Brenda B
authors.initials: BB
authors.lastname: Poindexter
authors.forename: C Michael
authors.initials: CM
authors.lastname: Cotten
authors.forename: Krisa P
authors.initials: KP
authors.lastname: Van Meurs
authors.forename: Shahnaz
authors.initials: S
authors.lastname: Duara
authors.forename: Vivek
authors.initials: V
authors.lastname: Narendran
authors.forename: Beena G
authors.initials: BG
authors.lastname: Sood
authors.forename: T Michael
authors.initials: TM
authors.lastname: O'Shea
authors.forename: Edward F
authors.initials: EF
authors.lastname: Bell
authors.forename: Richard A
authors.initials: RA
authors.lastname: Ehrenkranz
authors.forename: Kristi L
authors.initials: KL
authors.lastname: Watterberg
authors.forename: Rosemary D
authors.initials: RD
authors.lastname: Higgins
mesh_terms: D045422:Continuous Positive Airway Pressure; D005260:Female; D017052:Hospital Mortality; D006801:Humans; D007226:Infant Mortality; D007231:Infant, Newborn; D007234:Infant, Premature / Q000097:blood*; D007442:Intubation, Intratracheal; D053208:Kaplan-Meier Estimate; D008297:Male; D010092:Oximetry; D010100:Oxygen / Q000008:administration & dosage / Q000097:blood*; D010102:Oxygen Inhalation Therapy / Q000009:adverse effects / Q000379:methods*; D016016:Proportional Hazards Models; D011663:Pulmonary Surfactants / Q000627:therapeutic use; D012016:Reference Values; D012178:Retinopathy of Prematurity / Q000453:epidemiology / Q000517:prevention & control*
chemical_list: D011663:Pulmonary Surfactants; D010100:Oxygen
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