Thamrin, Valerie, Saugstad, Ola D., Tarnow-mordi, William, Wang, Yueping Alex, Lui, Kei, Wright, Ian M., De Waal, Koert, Travadi, Javeed, Smyth, John P., Craven, Paul, McMullan, Rowena, Coates, Elisabeth, Ward, Meredith, Mishra, Parag, See, Kwee Ching, Cheah, Irene G.S., Lim, Chin Theam, Choo, Yao Mun, Kamar, Azanna Ahmad, Cheah, Fook Choe, Masoud, Ahmed, and Oei, Ju Lee (2018) Preterm Infant Outcomes after Randomization to Initial Resuscitation with FiO2 0.21 or 1.0. Journal of Pediatrics, 201. 55-61.e1.

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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whom outcomes at age 2 years were available, 1 child had a lethal congenital anomaly, 1 child had consent for follow-up withdrawn, and 23 children died.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.

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