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Outcomes of Two Trials of Oxygen-Saturation Targets in Preterm Infants

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posted on 2023-05-19, 05:26 authored by Tarnow-Mordi, W, Stenson, B, Kirby, A, Juszczak, E, Donoghoe, M, Deshpande, S, Morley, C, King, A, Doyle, LW, Fleck, BW, Davis, PG, Halliday, HL, Hague, W, Cairns, P, Darlow, BA, Fielder, AR, Gebski, V, Marlow, N, Simmer, K, Tin, W, Ghadge, A, Williams, C, Keech, A, Wardle, SP, Kecskes, Z, Kluckow, M, Gole, G, Evans, N, Malcolm, G, Luig, M, Wright, I, Stack, J, Tan, K, Pritchard, M, Gray, PH, Morris, S, Headley, B, Peter DargavillePeter Dargaville, Simes, RJ, Brocklehurst, P
BACKGROUND: The safest ranges of oxygen saturation in preterm infants have been the subject of debate.

METHODS: In two trials, conducted in Australia and the United Kingdom, infants born before 28 weeks' gestation were randomly assigned to either a lower (85 to 89%) or a higher (91 to 95%) oxygen-saturation range. During enrollment, the oximeters were revised to correct a calibration-algorithm artifact. The primary outcome was death or disability at a corrected gestational age of 2 years; this outcome was evaluated among infants whose oxygen saturation was measured with any study oximeter in the Australian trial and those whose oxygen saturation was measured with a revised oximeter in the U.K. trial.

RESULTS: After 1135 infants in Australia and 973 infants in the United Kingdom had been enrolled in the trial, an interim analysis showed increased mortality at a corrected gestational age of 36 weeks, and enrollment was stopped. Death or disability in the Australian trial (with all oximeters included) occurred in 247 of 549 infants (45.0%) in the lower-target group versus 217 of 545 infants (39.8%) in the higher-target group (adjusted relative risk, 1.12; 95% confidence interval [CI], 0.98 to 1.27; P=0.10); death or disability in the U.K. trial (with only revised oximeters included) occurred in 185 of 366 infants (50.5%) in the lower-target group versus 164 of 357 infants (45.9%) in the higher-target group (adjusted relative risk, 1.10; 95% CI, 0.97 to 1.24; P=0.15). In post hoc combined, unadjusted analyses that included all oximeters, death or disability occurred in 492 of 1022 infants (48.1%) in the lower-target group versus 437 of 1013 infants (43.1%) in the higher-target group (relative risk, 1.11; 95% CI, 1.01 to 1.23; P=0.02), and death occurred in 222 of 1045 infants (21.2%) in the lower-target group versus 185 of 1045 infants (17.7%) in the higher-target group (relative risk, 1.20; 95% CI, 1.01 to 1.43; P=0.04). In the group in which revised oximeters were used, death or disability occurred in 287 of 580 infants (49.5%) in the lower-target group versus 248 of 563 infants (44.0%) in the higher-target group (relative risk, 1.12; 95% CI, 0.99 to 1.27; P=0.07), and death occurred in 144 of 587 infants (24.5%) versus 99 of 586 infants (16.9%) (relative risk, 1.45; 95% CI, 1.16 to 1.82; P=0.001).

CONCLUSIONS: Use of an oxygen-saturation target range of 85 to 89% versus 91 to 95% resulted in nonsignificantly higher rates of death or disability at 2 years in each trial but in significantly increased risks of this combined outcome and of death alone in post hoc combined analyses.

History

Publication title

New England Journal of Medicine

Volume

374

Issue

8

Pagination

749-760

ISSN

0028-4793

Department/School

Menzies Institute for Medical Research

Publisher

Massachusetts Medical Society

Place of publication

United States

Rights statement

© 2016 Massachusetts Medical Society. All rights reserved.

Repository Status

  • Open

Socio-economic Objectives

Neonatal and child health

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