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

Authors

Valerie Thamrin, University of New South Wales
Ola Saugstad, University of Oslo
William O. Tarnow-Mordi, Westmead Hospital, University of Sydney
Yueping Wang, University of Technology Sydney
Kei Lui, University of New South Wales, Royal Hospital for Women
Ian M. R Wright, University of Wollongong, University of NewcastleFollow
Koert de Waal, University of Newcastle, John Hunter Children's Hospital
Javeed Travadi, University of Newcastle, Hunter Medical Research Institute
John Smyth, University of New South Wales, University of Oslo
Paul D. Craven, University of Newcastle, John Hunter Children's Hospital
Rowena McMullan, Royal Prince Alfred Hospital
Elisabeth Coates, University of Sydney
Meredith Ward, University of New South Wales, Royal Hospital for Women
Parag Mishra, University of New South Wales, Royal Hospital for Women
Kwee See, Hospital Sungai Buloh
Irene Cheah, Kuala Lumpur Hospital
Chin Lim, University of Malaya Medical Centre
Yao Choo, University of Malaya Medical Centre
Azanna Kamar, University of Malaya Medical Centre
Fook Cheah, National University of Malaysia
Ahmed Masoud, Hamad Medical Corporation
Ju Lee Oei, University of New South Wales, Royal Hospital For Women, University of Sydney

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.