Preterm Infant Outcomes after Randomization to Initial Resuscitation with FiO2 0.21 or 1.0

Thamrin V 1 , Saugstad OD 2 , Tarnow-Mordi W 3 , Wang YA 4 , Lui K 5 , Wright IM 6 Show all authors , De Waal K 7 , Travadi J 7 , Smyth JP 8 , Craven P 7 , McMullan R 9 , Coates E 10 , Ward M 5 , Mishra P 5 , See KC 11 , Cheah IGS 12 , Lim CT 13 , Choo YM 13 , Kamar AA 13 , Cheah FC 14 , Masoud A 15 , Oei JL 16

Affiliations 

  • 1 School of Women's and Children's Health, The University of New South Wales, Sydney, NSW, Australia
  • 2 Department of Pediatric Research, The University of Oslo, Oslo, Norway
  • 3 NHMRC Clinical Trials Centre, The University of Sydney, Sydney, NSW, Australia; Westmead International Network for Neonatal Education and Research, Sydney, NSW, Australia
  • 4 Faculty of Health, University of Technology Sydney, Sydney, NSW, Australia
  • 5 School of Women's and Children's Health, The University of New South Wales, Sydney, NSW, Australia; Department of Newborn Care, The Royal Hospital for Women, Sydney, NSW, Australia
  • 6 Illawarra Health and Medical Research Institute and Graduate School of Medicine, The University of Wollongong, Wollongong, NSW, Australia; Hunter Medical Research Institute, University of Newcastle, Newcastle, NSW, Australia
  • 7 Hunter Medical Research Institute, University of Newcastle, Newcastle, NSW, Australia; Department of Neonatology, The John Hunter Hospital, Newcastle, NSW, Australia
  • 8 School of Women's and Children's Health, The University of New South Wales, Sydney, NSW, Australia; Department of Pediatric Research, The University of Oslo, Oslo, Norway
  • 9 Department of Neonatology, Royal Prince Alfred Hospital, Sydney, NSW, Australia
  • 10 NHMRC Clinical Trials Centre, The University of Sydney, Sydney, NSW, Australia
  • 11 Department of Neonatology, Sungai Buloh Hospital, Selangor, Malaysia
  • 12 Department of Neonatology, Hospital Kuala Lumpur, Kuala Lumpur, Malaysia
  • 13 Department of Neonatology, University of Malaya Medical Centre, Kuala Lumpur, Malaysia
  • 14 Department of Paediatrics, Universiti Kebangsaan Malaysia Medical Centre, Kuala Lumpur, Malaysia
  • 15 Hamad Medical Corporation, Doha, Qatar
  • 16 School of Women's and Children's Health, The University of New South Wales, Sydney, NSW, Australia; NHMRC Clinical Trials Centre, The University of Sydney, Sydney, NSW, Australia; Department of Newborn Care, The Royal Hospital for Women, Sydney, NSW, Australia. Electronic address: j.oei@unsw.edu.au
J Pediatr, 2018 10;201:55-61.e1.
PMID: 30251639 DOI: 10.1016/j.jpeds.2018.05.053

Abstract

OBJECTIVE: To determine rates of death or neurodevelopmental impairment (NDI) at 2 years corrected age (primary outcome) in children <32 weeks' gestation randomized to initial resuscitation with a fraction of inspired oxygen (FiO2) value of 0.21 or 1.0.

STUDY DESIGN: Blinded assessments were conducted at 2-3 years corrected age with the Bayley Scales of Infant and Toddler Development, Third Edition or the Ages and Stages Questionnaire by intention to treat.

RESULTS: Of the 290 children enrolled, 40 could not be contacted and 10 failed to attend appointments. Among the 240 children for whom outcomes at age 2 years were available, 1 child had a lethal congenital anomaly, 1 child had consent for follow-up withdrawn, and 23 children died. The primary outcome, which was available in 238 (82%) of those randomized, occurred in 47 of the 117 (40%) children assigned to initial FiO2 0.21 and in 38 of the 121 (31%) assigned to initial FiO2 1.0 (OR, 1.47; 95% CI, 0.86-2.5; P = .16). No difference in NDI was found in 215 survivors randomized to FiO2 0.21 vs 1.0 (OR, 1.26; 95% CI, 0.70-2.28; P = .11). In post hoc exploratory analyses in the whole cohort, children with a 5-minute blood oxygen saturation (SpO2) <80% were more likely to die or to have NDI (OR, 1.85; 95% CI, 1.07-3.2; P = .03).

CONCLUSIONS: Initial resuscitation of infants <32 weeks' gestation with initial FiO2 0.21 had no significant effect on death or NDI compared with initial FiO2 1.0. Further evaluation of optimum initial FiO2, including SpO2 targeting, in a large randomized controlled trial is needed.

TRIAL REGISTRATION: Australian and New Zealand Clinical Trials Network Registry ACTRN 12610001059055 and the National Malaysian Research Registry NMRR-07-685-957.

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

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