- Title
- Preterm Infant Outcomes after Randomization to Initial Resuscitation with FiO
2 0.21 or 1.0 - Creator
- Thamrin, Valerie; Saugstad, Ola D.; 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; Tarnow-Mordi, William; Masoud, Ahmed; Oei, JL; Wang, Yueping Alex; Lui, Kei; Wright, Ian M.; De Waal, Koert; Travadi, Javeed; Smyth, John P.; Craven, Paul
- Relation
- Journal of Pediatrics Vol. 201, Issue 1 October 2018, p. 55-61.e1
- Publisher Link
- http://dx.doi.org/10.1016/j.jpeds.2018.05.053
- Publisher
- Elsevier
- Resource Type
- journal article
- Date
- 2018
- Description
- 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whom outcomes at age 2 years were available, 1 child had a lethal congenital anomaly, 1 child had consent for follow-up withdrawn, and 23 children died.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.
- Subject
- oxygen; preterm; resuscitation; neurodevelopmental injury; death
- Identifier
- http://hdl.handle.net/1959.13/1440874
- Identifier
- uon:41245
- Identifier
- ISSN:0022-3476
- Language
- eng
- Reviewed
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