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Targeted Oxygen in the Resuscitation of Preterm Infants, a Randomized Clinical Trial.
- Source :
-
Pediatrics [Pediatrics] 2017 Jan; Vol. 139 (1). - Publication Year :
- 2017
-
Abstract
- Background and Objectives: Lower concentrations of oxygen (O <subscript>2</subscript> ) (≤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% O <subscript>2</subscript> on the combined risk of death and disability at 2 years in infants <32 weeks' gestation.<br />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% O <subscript>2</subscript> and which were adjusted to target pulse oximetry of 65% to 95% at 5 minutes and 85% to 95% until NICU admission.<br />Results: Of 6291 eligible patients, 292 were recruited and 287 (mean gestation: 28.9 weeks) were included in the analysis (RA: n = 144; 100% O <subscript>2</subscript> : 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% O <subscript>2</subscript> . In non-prespecified analyses, infants <28 weeks who received RA resuscitation had higher hospital mortality (RA: 10 of 46 [22%]; than those given 100% O <subscript>2</subscript> : 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).<br />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.<br /> (Copyright © 2017 by the American Academy of Pediatrics.)
- Subjects :
- Air
Child, Preschool
Disabled Children
Female
Follow-Up Studies
Gestational Age
Hospital Mortality
Humans
Infant
Infant, Newborn
Intensive Care Units, Neonatal
Male
Oximetry methods
Oxygen Inhalation Therapy adverse effects
Resuscitation mortality
Risk
Infant, Premature
Oxygen Inhalation Therapy methods
Resuscitation methods
Subjects
Details
- Language :
- English
- ISSN :
- 1098-4275
- Volume :
- 139
- Issue :
- 1
- Database :
- MEDLINE
- Journal :
- Pediatrics
- Publication Type :
- Academic Journal
- Accession number :
- 28034908
- Full Text :
- https://doi.org/10.1542/peds.2016-1452