Oxygen saturation and outcomes in preterm infants

The BOOST II United Kingdom, Australia, and New Zealand Collaborative Groups, Colditz, P., Pritchard, M., Gray, P., Shearman, A. and Poulson, L. (2013) Oxygen saturation and outcomes in preterm infants. New England Journal of Medicine, 368 22: 2094-2104. doi:10.1056/NEJMoa1302298

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Author The BOOST II United Kingdom, Australia, and New Zealand Collaborative Groups
Colditz, P.
Pritchard, M.
Gray, P.
Shearman, A.
Poulson, L.
Total Author Count Override 190
Title Oxygen saturation and outcomes in preterm infants
Journal name New England Journal of Medicine   Check publisher's open access policy
ISSN 0028-4793
1533-4406
Publication date 2013-05-30
Sub-type Article (original research)
DOI 10.1056/NEJMoa1302298
Open Access Status File (Publisher version)
Volume 368
Issue 22
Start page 2094
End page 2104
Total pages 11
Place of publication Boston, MA, United States
Publisher Massachusetts Medical Society
Collection year 2014
Language eng
Formatted abstract
Background The clinically appropriate range for oxygen saturation in preterm infants is unknown. Previous studies have shown that infants had reduced rates of retinopathy of prematurity when lower targets of oxygen saturation were used.

Methods In three international randomized, controlled trials, we evaluated the effects of targeting an oxygen saturation of 85 to 89%, as compared with a range of 91 to 95%, on disability-free survival at 2 years in infants born before 28 weeks' gestation. Halfway through the trials, the oximeter-calibration algorithm was revised. Recruitment was stopped early when an interim analysis showed an increased rate of death at 36 weeks in the group with a lower oxygen saturation. We analyzed pooled data from patients and now report hospital-discharge outcomes.

Results A total of 2448 infants were recruited. Among the 1187 infants whose treatment used the revised oximeter-calibration algorithm, the rate of death was significantly higher in the lower-target group than in the higher-target group (23.1% vs. 15.9%; relative risk in the lower-target group, 1.45; 95% confidence interval [CI], 1.15 to 1.84; P=0.002). There was heterogeneity for mortality between the original algorithm and the revised algorithm (P=0.006) but not for other outcomes. In all 2448 infants, those in the lower-target group for oxygen saturation had a reduced rate of retinopathy of prematurity (10.6% vs. 13.5%; relative risk, 0.79; 95% CI, 0.63 to 1.00; P=0.045) and an increased rate of necrotizing enterocolitis (10.4% vs. 8.0%; relative risk, 1.31; 95% CI, 1.02 to 1.68; P=0.04). There were no significant between-group differences in rates of other outcomes or adverse events.

Conclusions Targeting an oxygen saturation below 90% with the use of current oximeters in extremely preterm infants was associated with an increased risk of death. (Funded by the Australian National Health and Medical Research Council and others; BOOST II Current Controlled Trials number, ISRCTN00842661, and Australian New Zealand Clinical Trials Registry numbers, ACTRN12605000055606 and ACTRN12605000253606.)
Keyword Severe retinopathy
Pulse oximetry
Target ranges
Prematurity
Gestation
Crossover
Trial
Q-Index Code CX
Q-Index Status Confirmed Code
Institutional Status Non-UQ

Document type: Journal Article
Sub-type: Article (original research)
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Created: Mon, 16 Dec 2013, 09:52:09 EST by Roheen Gill on behalf of School of Medicine