Thamrin V, Saugstad OD, Tarnow-Mordi W, Wang YA, Lui K, Wright IM, De Waal K, Travadi J, Smyth JP, Craven P, McMullan R, Coates E, Ward M, Mishra P, See KC, Cheah IGS, Lim CT, Choo YM, Kamar AA, Cheah FC, Masoud A, and Oei JL
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 (FiO 2 ) 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whom outcomes at age 2 years were available, 1 child had a lethal congenital anomaly, 1 child had consent for follow-up withdrawn, and 23 children died.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 FiO 2 0.21 and in 38 of the 121 (31%) assigned to initial FiO 2 1.0 (OR, 1.47; 95% CI, 0.86-2.5; P = .16). No difference in NDI was found in 215 survivors randomized to FiO 2 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 (SpO 2 ) <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 FiO 2 0.21 had no significant effect on death or NDI compared with initial FiO 2 1.0. Further evaluation of optimum initial FiO 2 , including SpO 2 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., (Copyright © 2018 Elsevier Inc. All rights reserved.)