Preterm Infant Outcomes after Randomization to Initial Resuscitation with FiO <inf>2</inf> 0.21 or 1.0

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; Oei, JL

Preterm Infant Outcomes after Randomization to Initial Resuscitation with FiO <inf>2</inf> 0.21 or 1.0

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 Oei, JL

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Publication Type:: Journal Article
Citation:: Journal of Pediatrics, 2018, 201 pp. 55 - 61.e1
Issue Date:: 2018-10-01

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Field	Value	Language
dc.contributor.author	Thamrin, V	en_US
dc.contributor.author	Saugstad, OD	en_US
dc.contributor.author	Tarnow-Mordi, W	en_US
dc.contributor.author	Wang, YA https://orcid.org/0000-0002-3656-4284	en_US
dc.contributor.author	Lui, K	en_US
dc.contributor.author	Wright, IM	en_US
dc.contributor.author	De Waal, K	en_US
dc.contributor.author	Travadi, J	en_US
dc.contributor.author	Smyth, JP	en_US
dc.contributor.author	Craven, P	en_US
dc.contributor.author	McMullan, R	en_US
dc.contributor.author	Coates, E	en_US
dc.contributor.author	Ward, M	en_US
dc.contributor.author	Mishra, P	en_US
dc.contributor.author	See, KC	en_US
dc.contributor.author	Cheah, IGS	en_US
dc.contributor.author	Lim, CT	en_US
dc.contributor.author	Choo, YM	en_US
dc.contributor.author	Kamar, AA	en_US
dc.contributor.author	Cheah, FC	en_US
dc.contributor.author	Masoud, A	en_US
dc.contributor.author	Oei, JL	en_US
dc.date.available	2018-05-31	en_US
dc.date.issued	2018-10-01	en_US
dc.identifier.citation	Journal of Pediatrics, 2018, 201 pp. 55 - 61.e1	en_US
dc.identifier.issn	0022-3476	en_US
dc.identifier.uri	http://hdl.handle.net/10453/129589
dc.description.abstract	© 2018 Elsevier Inc. 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.	en_US
dc.relation.ispartof	Journal of Pediatrics	en_US
dc.relation.isbasedon	10.1016/j.jpeds.2018.05.053	en_US
dc.subject.classification	Pediatrics	en_US
dc.subject.mesh	Humans	en_US
dc.subject.mesh	Oxygen	en_US
dc.subject.mesh	Resuscitation	en_US
dc.subject.mesh	Oxygen Inhalation Therapy	en_US
dc.subject.mesh	Follow-Up Studies	en_US
dc.subject.mesh	Aptitude Tests	en_US
dc.subject.mesh	Gestational Age	en_US
dc.subject.mesh	Child, Preschool	en_US
dc.subject.mesh	Infant, Newborn	en_US
dc.subject.mesh	Infant, Premature	en_US
dc.subject.mesh	Female	en_US
dc.subject.mesh	Male	en_US
dc.subject.mesh	Neurodevelopmental Disorders	en_US
dc.title	Preterm Infant Outcomes after Randomization to Initial Resuscitation with FiO <inf>2</inf> 0.21 or 1.0	en_US
dc.type	Journal Article
utslib.citation.volume	201	en_US
utslib.for	1114 Paediatrics and Reproductive Medicine	en_US
utslib.for	1106 Human Movement and Sports Sciences	en_US
pubs.embargo.period	Not known	en_US
pubs.organisational-group	/University of Technology Sydney
pubs.organisational-group	/University of Technology Sydney/Faculty of Health
pubs.organisational-group	/University of Technology Sydney/Faculty of Health/Public Health
pubs.organisational-group	/University of Technology Sydney/Strength - CHSP - Health Services and Practice
utslib.copyright.status	closed_access
pubs.publication-status	Published	en_US
pubs.volume	201	en_US

Abstract:

© 2018 Elsevier Inc. 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.

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http://hdl.handle.net/10453/129589