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N Engl J Med. 2010 May 27;362(21):1959-69. doi: 10.1056/NEJMoa0911781. Epub 2010 May 16.

Target ranges of oxygen saturation in extremely preterm infants.

Collaborators (133)

Jobe AH, Caplan MS, Oh W, Hensman AM, Gingras D, Barnett S, Lillie S, Francis K, Andrews D, Angela K, Fanaroff AA, Siner BS, Zadell A, DiFiore J, Donovan EF, Bridges K, Alexander B, Grisby C, Mersmann MW, Mincey HL, Hessling J, Goldberg RN, Auten KJ, Fisher KA, Foy KA, Siaw G, Stoll BJ, Buchter S, Carlton DP, Hale EC, Hutchinson AK, Archer SW, Lemons JA, Hamer F, Herron DE, Miller LC, Wilson LD, Berberich MA, Blaisdell CJ, Gail DB, Kiley JP, Cunningham M, Hastings BK, Irene AR, Auman JO, Huitema CP, Pickett JW 2nd, Wallace D, Zaterka-Baxter KM, Stevenson DK, Ball MB, Proud MS, Fiascone JM, Furey A, MacKinnon BL, Nylen E, Collins MV, Cosby SS, Phillips VA, Rasmussen MR, Wozniak PR, Arnell K, Bridge R, Demetrio C, Widness JA, Klein JM, Johnson KJ, Everett-Thomas R, Ohls RK, Rohr J, Lacy CB, Markowitz GD, Reubens LJ, Burnell E, Rosenfeld CR, Salhab WA, Guzman A, Hensley G, Lepps MH, Miller NA, Allen J, Grau L, Martin M, Solis A, Vasil DM, Wilder K, Kennedy KA, Tyson JE, Harris BF, Lis AE, Martin S, McDavid G, Tate PL, Wright SL, Burnett J, Jensen JJ, Osborne KA, Spencer C, Weaver-Lewis K, Peters NJ, Shankaran S, Bara R, Billian E, Johnson M, Bhandari V, Jacobs HC, Cervone P, Gettner P, Konstantino M, Poulsen J, Taft J, Avery G, Gleason CA, Allen MC, Bangdiwala SI, Blaisdell CJ, Boyle RJ, Clemons T, D'Alton ME, Das A, Gail DB, Hunt C, Keszler M, Poole WK, Redmond CK, Ross MG, Thomson MA, Weiner SJ, Willinger M, Markowitz GD, Hutchinson AK, Wallace DK, Freedman SF.

Abstract

BACKGROUND:

Previous studies have suggested that the incidence of retinopathy is lower in preterm infants with exposure to reduced levels of oxygenation than in those exposed to higher levels of oxygenation. However, it is unclear what range of oxygen saturation is appropriate to minimize retinopathy without increasing adverse outcomes.

METHODS:

We performed a randomized trial with a 2-by-2 factorial design to compare target ranges of oxygen saturation of 85 to 89% or 91 to 95% among 1316 infants who were born between 24 weeks 0 days and 27 weeks 6 days of gestation. The primary outcome was a composite of severe retinopathy of prematurity (defined as the presence of threshold retinopathy, the need for surgical ophthalmologic intervention, or the use of bevacizumab), death before discharge from the hospital, or both. All infants were also randomly assigned to continuous positive airway pressure or intubation and surfactant.

RESULTS:

The rates of severe retinopathy or death did not differ significantly between the lower-oxygen-saturation group and the higher-oxygen-saturation group (28.3% and 32.1%, respectively; relative risk with lower oxygen saturation, 0.90; 95% confidence interval [CI], 0.76 to 1.06; P=0.21). Death before discharge occurred more frequently in the lower-oxygen-saturation group (in 19.9% of infants vs. 16.2%; relative risk, 1.27; 95% CI, 1.01 to 1.60; P=0.04), whereas severe retinopathy among survivors occurred less often in this group (8.6% vs. 17.9%; relative risk, 0.52; 95% CI, 0.37 to 0.73; P<0.001). There were no significant differences in the rates of other adverse events.

CONCLUSIONS:

A lower target range of oxygenation (85 to 89%), as compared with a higher range (91 to 95%), did not significantly decrease the composite outcome of severe retinopathy or death, but it resulted in an increase in mortality and a substantial decrease in severe retinopathy among survivors. The increase in mortality is a major concern, since a lower target range of oxygen saturation is increasingly being advocated to prevent retinopathy of prematurity. (ClinicalTrials.gov number, NCT00233324.)

PMID:
20472937
PMCID:
PMC2891970
DOI:
10.1056/NEJMoa0911781
[Indexed for MEDLINE]
Free PMC Article

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