title: Outcomes of Two Trials of Oxygen-Saturation Targets in Preterm Infants.
abstract: BACKGROUND
  The safest ranges of oxygen saturation in preterm infants have been the subject of debate.
  
  
  METHODS
  In two trials, conducted in Australia and the United Kingdom, infants born before 28 weeks' gestation were randomly assigned to either a lower (85 to 89%) or a higher (91 to 95%) oxygen-saturation range. During enrollment, the oximeters were revised to correct a calibration-algorithm artifact. The primary outcome was death or disability at a corrected gestational age of 2 years; this outcome was evaluated among infants whose oxygen saturation was measured with any study oximeter in the Australian trial and those whose oxygen saturation was measured with a revised oximeter in the U.K. trial.
  
  
  RESULTS
  After 1135 infants in Australia and 973 infants in the United Kingdom had been enrolled in the trial, an interim analysis showed increased mortality at a corrected gestational age of 36 weeks, and enrollment was stopped. Death or disability in the Australian trial (with all oximeters included) occurred in 247 of 549 infants (45.0%) in the lower-target group versus 217 of 545 infants (39.8%) in the higher-target group (adjusted relative risk, 1.12; 95% confidence interval [CI], 0.98 to 1.27; P=0.10); death or disability in the U.K. trial (with only revised oximeters included) occurred in 185 of 366 infants (50.5%) in the lower-target group versus 164 of 357 infants (45.9%) in the higher-target group (adjusted relative risk, 1.10; 95% CI, 0.97 to 1.24; P=0.15). In post hoc combined, unadjusted analyses that included all oximeters, death or disability occurred in 492 of 1022 infants (48.1%) in the lower-target group versus 437 of 1013 infants (43.1%) in the higher-target group (relative risk, 1.11; 95% CI, 1.01 to 1.23; P=0.02), and death occurred in 222 of 1045 infants (21.2%) in the lower-target group versus 185 of 1045 infants (17.7%) in the higher-target group (relative risk, 1.20; 95% CI, 1.01 to 1.43; P=0.04). In the group in which revised oximeters were used, death or disability occurred in 287 of 580 infants (49.5%) in the lower-target group versus 248 of 563 infants (44.0%) in the higher-target group (relative risk, 1.12; 95% CI, 0.99 to 1.27; P=0.07), and death occurred in 144 of 587 infants (24.5%) versus 99 of 586 infants (16.9%) (relative risk, 1.45; 95% CI, 1.16 to 1.82; P=0.001).
  
  
  CONCLUSIONS
  Use of an oxygen-saturation target range of 85 to 89% versus 91 to 95% resulted in nonsignificantly higher rates of death or disability at 2 years in each trial but in significantly increased risks of this combined outcome and of death alone in post hoc combined analyses. (Funded by the Australian National Health and Medical Research Council and others; BOOST-II Current Controlled Trials number, ISRCTN00842661, and Australian New Zealand Clinical Trials Registry number, ACTRN12605000055606.).
authors: William
authors: W
authors: Tarnow-Mordi
authors: Ben
authors: B
authors: Stenson
authors: Adrienne
authors: A
authors: Kirby
authors: Edmund
authors: E
authors: Juszczak
authors: Mark
authors: M
authors: Donoghoe
authors: Sanjeev
authors: S
authors: Deshpande
authors: Colin
authors: C
authors: Morley
authors: Andrew
authors: A
authors: King
authors: Lex W
authors: LW
authors: Doyle
authors: Brian W
authors: BW
authors: Fleck
authors: Peter G
authors: PG
authors: Davis
authors: Henry L
authors: HL
authors: Halliday
authors: Wendy
authors: W
authors: Hague
authors: Pamela
authors: P
authors: Cairns
authors: Brian A
authors: BA
authors: Darlow
authors: Alistair R
authors: AR
authors: Fielder
authors: Val
authors: V
authors: Gebski
authors: Neil
authors: N
authors: Marlow
authors: Karen
authors: K
authors: Simmer
authors: Win
authors: W
authors: Tin
authors: Alpana
authors: A
authors: Ghadge
authors: Cathy
authors: C
authors: Williams
authors: Anthony
authors: A
authors: Keech
authors: Stephen P
authors: SP
authors: Wardle
authors: Zsuzsoka
authors: Z
authors: Kecskes
authors: Martin
authors: M
authors: Kluckow
authors: Glen
authors: G
authors: Gole
authors: Nicholas
authors: N
authors: Evans
authors: Girvan
authors: G
authors: Malcolm
authors: Melissa
authors: M
authors: Luig
authors: Ian
authors: I
authors: Wright
authors: Jacqueline
authors: J
authors: Stack
authors: Kenneth
authors: K
authors: Tan
authors: Margo
authors: M
authors: Pritchard
authors: Peter H
authors: PH
authors: Gray
authors: Scott
authors: S
authors: Morris
authors: Bevan
authors: B
authors: Headley
authors: Peter
authors: P
authors: Dargaville
authors: R John
authors: RJ
authors: Simes
authors: Peter
authors: P
authors: Brocklehurst
mesh_terms: D001315:Australia; D002675:Child, Preschool; D002658:Developmental Disabilities / Q000453:epidemiology*; D005260:Female; D006801:Humans; D007223:Infant; D007226:Infant Mortality; D062071:Infant, Extremely Premature / Q000097:blood*; D007231:Infant, Newborn; D008297:Male; D010092:Oximetry; D010100:Oxygen / Q000097:blood*; D010102:Oxygen Inhalation Therapy / Q000009:adverse effects / Q000379:methods*; D012306:Risk; D006113:United Kingdom
chemical_list: D010100:Oxygen