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Targeted Oxygen in the Resuscitation of Preterm Infants, a Randomized Clinical Trial

Oei JL 1 , Saugstad OD 2 , Lui K 3 , Wright IM 4 , Smyth JP 3 , Craven P 5 Show all authors , Wang YA 6 , McMullan R 7 , Coates E 8 , Ward M 3 , Mishra P 3 , De Waal K 5 , Travadi J 5 , See KC 9 , Cheah IG 10 , Lim CT 11 , Choo YM 11 , Kamar AA 11 , Cheah FC 12 , Masoud A 13 , Tarnow-Mordi W 8

Affiliations 

  • 1 School of Women's and Children's Health, the University of New South Wales, Australia; j.oei@unsw.edu.au
  • 2 Department of Pediatric Research, Olso University Hospital, University of Oslo, Oslo, Norway
  • 3 School of Women's and Children's Health, the University of New South Wales, Australia
  • 4 Illawarra Health and Medical Research Institute and Graduate Medicine, The University of Wollongong, Australia
  • 5 Department of Neonatology, John Hunter Hospital, Australia
  • 6 Faculty of Health, University of Technology Sydney, Australia
  • 7 Department of Neonatology, Royal Prince Alfred Hospital, Australia
  • 8 Westmead International Network for Neonatal Education and Research, (WINNER Centre), NHMRC Clinical Trials Centre, University of Sydney, Sydney, Australia
  • 9 Sungai Buloh Hospital, Selangor, Malaysia
  • 10 Department of Paediatrics, Hospital Kuala Lumpur, Kuala Lumpur, Malaysia
  • 11 Department of Paediatrics, University Malaya, Kuala Lumpur, Malaysia
  • 12 Department of Paediatrics, Universiti Kebangsaan Malaysia Medical Center, Kuala Lumpar, Malaysia; and
  • 13 Hamad Medical Corporation, Qatar
Pediatrics, 2017 01;139(1).
PMID: 28034908 DOI: 10.1542/peds.2016-1452

Abstract

BACKGROUND AND OBJECTIVES: Lower concentrations of oxygen (O2) (≤30%) are recommended for preterm resuscitation to avoid oxidative injury and cerebral ischemia. Effects on long-term outcomes are uncertain. We aimed to determine the effects of using room air (RA) or 100% O2 on the combined risk of death and disability at 2 years in infants <32 weeks' gestation.

METHODS: A randomized, unmasked study designed to determine major disability and death at 2 years in infants <32 weeks' gestation after delivery room resuscitation was initiated with either RA or 100% O2 and which were adjusted to target pulse oximetry of 65% to 95% at 5 minutes and 85% to 95% until NICU admission.

RESULTS: Of 6291 eligible patients, 292 were recruited and 287 (mean gestation: 28.9 weeks) were included in the analysis (RA: n = 144; 100% O2: n = 143). Recruitment ceased in June 2014, per the recommendations of the Data and Safety Monitoring Committee owing to loss of equipoise for the use of 100% O2. In non-prespecified analyses, infants <28 weeks who received RA resuscitation had higher hospital mortality (RA: 10 of 46 [22%]; than those given 100% O2: 3 of 54 [6%]; risk ratio: 3.9 [95% confidence interval: 1.1-13.4]; P = .01). Respiratory failure was the most common cause of death (n = 13).

CONCLUSIONS: Using RA to initiate resuscitation was associated with an increased risk of death in infants <28 weeks' gestation. This study was not a prespecified analysis, and it was underpowered to address this post hoc hypothesis reliably. Additional data are needed.

* Title and MeSH Headings from MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine.

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