Association Between Oxygen Saturation Targeting and Death or Disability in Extremely Preterm Infants in the Neonatal Oxygenation Prospective Meta-analysis Collaboration

Neonatal Oxygenation Prospective Meta-analysis (NeOProM) Collaboration, Lisa M Askie, Brian A Darlow, Neil Finer, Barbara Schmidt, Ben Stenson, William Tarnow-Mordi, Peter G Davis, Waldemar A Carlo, Peter Brocklehurst, Lucy C Davies, Abhik Das, Wade Rich, Marie G Gantz, Robin S Roberts, Robin K Whyte, Lorrie Costantini, Christian Poets, Elizabeth Asztalos, Malcolm BattinHenry L Halliday, Neil Marlow, Win Tin, Andrew King, Edmund Juszczak, Colin J Morley, Lex W Doyle, Val Gebski, Kylie E Hunter, Robert J Simes

Research output: Contribution to journalArticlepeer-review

Abstract

Importance: There are potential benefits and harms of hyperoxemia and hypoxemia for extremely preterm infants receiving more vs less supplemental oxygen.

Objective: To compare the effects of different target ranges for oxygen saturation as measured by pulse oximetry (Spo2) on death or major morbidity.

Design, Setting, and Participants: Prospectively planned meta-analysis of individual participant data from 5 randomized clinical trials (conducted from 2005-2014) enrolling infants born before 28 weeks' gestation.

Exposures: Spo2 target range that was lower (85%-89%) vs higher (91%-95%).

Main Outcomes and Measures: The primary outcome was a composite of death or major disability (bilateral blindness, deafness, cerebral palsy diagnosed as ≥2 level on the Gross Motor Function Classification System, or Bayley-III cognitive or language score <85) at a corrected age of 18 to 24 months. There were 16 secondary outcomes including the components of the primary outcome and other major morbidities.

Results: A total of 4965 infants were randomized (2480 to the lower Spo2 target range and 2485 to the higher Spo2 range) and had a median gestational age of 26 weeks (interquartile range, 25-27 weeks) and a mean birth weight of 832 g (SD, 190 g). The primary outcome occurred in 1191 of 2228 infants (53.5%) in the lower Spo2 target group and 1150 of 2229 infants (51.6%) in the higher Spo2 target group (risk difference, 1.7% [95% CI, -1.3% to 4.6%]; relative risk [RR], 1.04 [95% CI, 0.98 to 1.09], P = .21). Of the 16 secondary outcomes, 11 were null, 2 significantly favored the lower Spo2 target group, and 3 significantly favored the higher Spo2 target group. Death occurred in 484 of 2433 infants (19.9%) in the lower Spo2 target group and 418 of 2440 infants (17.1%) in the higher Spo2 target group (risk difference, 2.8% [95% CI, 0.6% to 5.0%]; RR, 1.17 [95% CI, 1.04 to 1.31], P = .01). Treatment for retinopathy of prematurity was administered to 220 of 2020 infants (10.9%) in the lower Spo2 target group and 308 of 2065 infants (14.9%) in the higher Spo2 target group (risk difference, -4.0% [95% CI, -6.1% to -2.0%]; RR, 0.74 [95% CI, 0.63 to 0.86], P < .001). Severe necrotizing enterocolitis occurred in 227 of 2464 infants (9.2%) in the lower Spo2 target group and 170 of 2465 infants (6.9%) in the higher Spo2 target group (risk difference, 2.3% [95% CI, 0.8% to 3.8%]; RR, 1.33 [95% CI, 1.10 to 1.61], P = .003).

Conclusions and Relevance: In this prospectively planned meta-analysis of individual participant data from extremely preterm infants, there was no significant difference between a lower Spo2 target range compared with a higher Spo2 target range on the primary composite outcome of death or major disability at a corrected age of 18 to 24 months. The lower Spo2 target range was associated with a higher risk of death and necrotizing enterocolitis, but a lower risk of retinopathy of prematurity treatment.

Original languageEnglish
Pages (from-to)2190-2201
Number of pages12
JournalJournal of the American Medical Association
Volume319
Issue number21
DOIs
Publication statusPublished - 5 Jun 2018

Keywords

  • Blindness
  • Cerebral Palsy
  • Deafness
  • Developmental Disabilities
  • Enterocolitis, Necrotizing
  • Female
  • Humans
  • Incidence
  • Infant
  • Infant Mortality
  • Infant, Extremely Premature
  • Infant, Newborn
  • Infant, Premature, Diseases
  • Kaplan-Meier Estimate
  • Male
  • Oximetry
  • Oxygen
  • Randomized Controlled Trials as Topic
  • Comparative Study
  • Journal Article
  • Meta-Analysis
  • Research Support, N.I.H., Extramural
  • Research Support, Non-U.S. Gov't

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