Title

Preterm Infant Outcomes after Randomization to Initial Resuscitation with FiO(2) 0.21 or 1.0

RIS ID

136057

Publication Details

Thamrin, V., Saugstad, O. D., Tarnow-Mordi, W., Wang, Y., Lui, K., Wright, I. M., de Waal, K., Travadi, J., Smyth, J. P., Craven, P., McMullan, R., Coates, E., Ward, M., Mishra, P., See, K. Ching., Cheah, I. G. S., Lim, C. Theam., Choo, Y. Mun., Kamar, A. Ahmad., Cheah, F. Choe., Masoud, A. & Oei, J. (2018). Preterm Infant Outcomes after Randomization to Initial Resuscitation with FiO(2) 0.21 or 1.0. Journal of Pediatrics, 201 55-61.e1.

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outcomes at age 2 years were available, 1 child had a lethal congenital anomaly, 1 child had consent for follow-up withdrawn, and 23 children died.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

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Link to publisher version (DOI)

http://dx.doi.org/10.1016/j.jpeds.2018.05.053