Title

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

RIS ID

111797

Publication Details

Oei, J., Saugstad, O., Lui, K., Wright, I., Smyth, J. P., Craven, P., Wang, Y. Alex., McMullan, R., Coates, E., Ward, M., Mishra, P., De Waal, K., Travadi, J., See, K. Ching., Cheah, I. G.S., Lim, C. Theam., Choo, Y. Mun., Kamar, A. Ahmad., Cheah, F. Choe., Masoud, A. & Tarnow-Mordi, W. (2017). Targeted Oxygen in the Resuscitation of Preterm Infants, a Randomized Clinical Trial. Pediatrics, 139 (1), 1-11.

Abstract

BACKGROUND AND OBJECTIVES: Lower concentrations of oxygen (O2) (≤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 (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.

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Link to publisher version (DOI)

http://dx.doi.org/10.1542/peds.2016-1452