Targeted Oxygen in the Resuscitation of Preterm Infants, a Randomized Clinical Trial

Oei, JL; Saugstad, OD; Lui, K; Wright, IM; Smyth, JP; Craven, P; Wang, YA; McMullan, R; Coates, E; Ward, M; Mishra, P; De Waal, K; Travadi, J; See, KC; Cheah, IGS; Lim, CT; Choo, YM; Kamar, AA; Cheah, FC; Masoud, A; Tarnow-Mordi, W

Targeted Oxygen in the Resuscitation of Preterm Infants, a Randomized Clinical Trial

Oei, JL Saugstad, OD Lui, K Wright, IM Smyth, JP Craven, P Wang, YA

McMullan, R Coates, E Ward, M Mishra, P De Waal, K Travadi, J See, KC Cheah, IGS Lim, CT Choo, YM Kamar, AA Cheah, FC Masoud, A Tarnow-Mordi, W

Permalink

Publication Type:: Journal Article
Citation:: Pediatrics, 2017, 139 (1)
Issue Date:: 2017-01-01

Closed Access

	Filename	Description	Size
	e20161452.full.pdf	Published Version	1.41 MB	Adobe PDF	View/Open

Copyright Clearance Process

Recently Added
In Progress
Closed Access

This item is closed access and not available.

Full metadata record

Field	Value	Language
dc.contributor.author	Oei, JL	en_US
dc.contributor.author	Saugstad, OD	en_US
dc.contributor.author	Lui, K	en_US
dc.contributor.author	Wright, IM	en_US
dc.contributor.author	Smyth, JP	en_US
dc.contributor.author	Craven, P	en_US
dc.contributor.author	Wang, YA https://orcid.org/0000-0002-3656-4284	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	De Waal, K	en_US
dc.contributor.author	Travadi, J	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	Tarnow-Mordi, W	en_US
dc.date.available	2016-10-14	en_US
dc.date.issued	2017-01-01	en_US
dc.identifier.citation	Pediatrics, 2017, 139 (1)	en_US
dc.identifier.issn	0031-4005	en_US
dc.identifier.uri	http://hdl.handle.net/10453/125076
dc.description.abstract	Copyright © 2017 by the American Academy of Pediatrics. BACKGROUND AND OBJECTIVES: Lower concentrations of oxygen (O abstract 2) (≤30%) are recommended for preterm resuscitation to avoid oxidative injury and cerebral ischemia. Effects on long-term outcomes are uncertain. We aimed to determine the effects of using room air (RA) or 100% O2 on the combined risk of death and disability at 2 years in infants <32 weeks' gestation. METHODS: A randomized, unmasked study designed to determine major disability and death at 2 years in infants <32 weeks' gestation after delivery room resuscitation was initiated with either RA or 100% O2 and which were adjusted to target pulse oximetry of 65% to 95% at 5 minutes and 85% to 95% until NICU admission. RESULTS: Of 6291 eligible patients, 292 were recruited and 287 (mean gestation: 28.9 weeks) were included in the analysis (RA: n = 144; 100% O2: n = 143). Recruitment ceased in June 2014, per the recommendations of the Data and Safety Monitoring Committee owing to loss of equipoise for the use of 100% O2. In non-prespecified analyses, infants <28 weeks who received RA resuscitation had higher hospital mortality (RA: 10 of 46 [22%]; than those given 100% O2: 3 of 54 [6%]; risk ratio: 3.9 [95% confidence interval: 1.1-13.4]; P = .01). Respiratory failure was the most common cause of death (n = 13). CONCLUSIONS: Using RA to initiate resuscitation was associated with an increased risk of death in infants <28 weeks' gestation. This study was not a prespecified analysis, and it was underpowered to address this post hoc hypothesis reliably. Additional data are needed.	en_US
dc.relation.ispartof	Pediatrics	en_US
dc.relation.isbasedon	10.1542/peds.2016-1452	en_US
dc.subject.classification	Pediatrics	en_US
dc.subject.mesh	Humans	en_US
dc.subject.mesh	Oximetry	en_US
dc.subject.mesh	Resuscitation	en_US
dc.subject.mesh	Oxygen Inhalation Therapy	en_US
dc.subject.mesh	Hospital Mortality	en_US
dc.subject.mesh	Risk	en_US
dc.subject.mesh	Follow-Up Studies	en_US
dc.subject.mesh	Air	en_US
dc.subject.mesh	Gestational Age	en_US
dc.subject.mesh	Child, Preschool	en_US
dc.subject.mesh	Infant	en_US
dc.subject.mesh	Infant, Newborn	en_US
dc.subject.mesh	Infant, Premature	en_US
dc.subject.mesh	Disabled Children	en_US
dc.subject.mesh	Intensive Care Units, Neonatal	en_US
dc.subject.mesh	Female	en_US
dc.subject.mesh	Male	en_US
dc.title	Targeted Oxygen in the Resuscitation of Preterm Infants, a Randomized Clinical Trial	en_US
dc.type	Journal Article
utslib.citation.volume	1	en_US
utslib.citation.volume	139	en_US
utslib.for	1103 Clinical Sciences	en_US
utslib.for	1114 Paediatrics and Reproductive Medicine	en_US
utslib.for	1110 Nursing	en_US
utslib.for	11 Medical and Health Sciences	en_US
utslib.for	17 Psychology and Cognitive 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.issue	1	en_US
pubs.publication-status	Published	en_US
pubs.volume	139	en_US

Abstract:

Copyright © 2017 by the American Academy of Pediatrics. BACKGROUND AND OBJECTIVES: Lower concentrations of oxygen (O abstract 2) (≤30%) are recommended for preterm resuscitation to avoid oxidative injury and cerebral ischemia. Effects on long-term outcomes are uncertain. We aimed to determine the effects of using room air (RA) or 100% O2 on the combined risk of death and disability at 2 years in infants <32 weeks' gestation. METHODS: A randomized, unmasked study designed to determine major disability and death at 2 years in infants <32 weeks' gestation after delivery room resuscitation was initiated with either RA or 100% O2 and which were adjusted to target pulse oximetry of 65% to 95% at 5 minutes and 85% to 95% until NICU admission. RESULTS: Of 6291 eligible patients, 292 were recruited and 287 (mean gestation: 28.9 weeks) were included in the analysis (RA: n = 144; 100% O2: n = 143). Recruitment ceased in June 2014, per the recommendations of the Data and Safety Monitoring Committee owing to loss of equipoise for the use of 100% O2. In non-prespecified analyses, infants <28 weeks who received RA resuscitation had higher hospital mortality (RA: 10 of 46 [22%]; than those given 100% O2: 3 of 54 [6%]; risk ratio: 3.9 [95% confidence interval: 1.1-13.4]; P = .01). Respiratory failure was the most common cause of death (n = 13). CONCLUSIONS: Using RA to initiate resuscitation was associated with an increased risk of death in infants <28 weeks' gestation. This study was not a prespecified analysis, and it was underpowered to address this post hoc hypothesis reliably. Additional data are needed.

Please use this identifier to cite or link to this item:

http://hdl.handle.net/10453/125076