Target ranges of oxygen saturation in extremely preterm infants

Waldemar A Carlo; Neil N Finer; Michele C Walsh; Wade Rich; Marie G Gantz; Abbot R Laptook; Bradley A Yoder; Roger G Faix; Abhik Das; W Kenneth Poole; Kurt Schibler; Nancy S Newman; Namasivayam Ambalavanan; Ivan D Frantz III; Anthony J Piazza; Pablo J Sánchez; Brenda H Morris; Nirupama Laroia; Dale L Phelps; Brenda B Poindexter; C Michael Cotten; Krisa P Van Meurs; Shahnaz Duara; Vivek Narendran; Beena G Sood; T Michael O'Shea; Edward F Bell; Richard A Ehrenkranz; Kristi L Watterberg; Rosemary D Higgins; SUPPORT Study Group of the Eunice Kennedy Shriver NICHD Neonatal Research Network

doi:10.1056/NEJMoa0911781

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Target ranges of oxygen saturation in extremely preterm infants

Journal article

Open access

Peer reviewed

Target ranges of oxygen saturation in extremely preterm infants

Waldemar A Carlo, Neil N Finer, Michele C Walsh, Wade Rich, Marie G Gantz, Abbot R Laptook, Bradley A Yoder, Roger G Faix, Abhik Das, W Kenneth Poole, …

The New England journal of medicine, Vol.362(21), pp.1959-1969

05/27/2010

DOI: 10.1056/NEJMoa0911781

PMCID: PMC2891970

PMID: 20472937

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Abstract

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. 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. 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. 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.)

Continuous Positive Airway Pressure

Hospital Mortality

Infant Mortality

Humans

Oximetry

Kaplan-Meier Estimate

Proportional Hazards Models

Male

Reference Values

Retinopathy of Prematurity - epidemiology

Pulmonary Surfactants - therapeutic use

Oxygen - blood

Oxygen - administration & dosage

Infant, Premature - blood

Oxygen Inhalation Therapy - adverse effects

Female

Retinopathy of Prematurity - prevention & control

Oxygen Inhalation Therapy - methods

Intubation, Intratracheal

Infant, Newborn

Details

Title: Subtitle: Target ranges of oxygen saturation in extremely preterm infants
Creators: Waldemar A Carlo
Neil N Finer
Michele C Walsh
Wade Rich
Marie G Gantz
Abbot R Laptook
Bradley A Yoder
Roger G Faix
Abhik Das
W Kenneth Poole
Kurt Schibler
Nancy S Newman
Namasivayam Ambalavanan
Ivan D Frantz III
Anthony J Piazza
Pablo J Sánchez
Brenda H Morris
Nirupama Laroia
Dale L Phelps
Brenda B Poindexter
C Michael Cotten
Krisa P Van Meurs
Shahnaz Duara
Vivek Narendran
Beena G Sood
T Michael O'Shea
Edward F Bell
Richard A Ehrenkranz
Kristi L Watterberg
Rosemary D Higgins
SUPPORT Study Group of the Eunice Kennedy Shriver NICHD Neonatal Research Network
Resource Type: Journal article
Publication Details: The New England journal of medicine, Vol.362(21), pp.1959-1969
DOI: 10.1056/NEJMoa0911781
PMID: 20472937
PMCID: PMC2891970
ISSN: 0028-4793
eISSN: 1533-4406
Grant note: UG1 HD053089 / NICHD NIH HHS UG1 HD040492 / NICHD NIH HHS U10 HD53089 / NICHD NIH HHS U10 HD027871 / NICHD NIH HHS U10 HD040498 / NICHD NIH HHS U10 HD021373 / NICHD NIH HHS U10 HD040492 / NICHD NIH HHS M01 RR39 / NCRR NIH HHS U10 HD053124-03 / NICHD NIH HHS U10 HD040521 / NICHD NIH HHS U10 HD053089 / NICHD NIH HHS M01 RR70 / NCRR NIH HHS U10 HD040689 / NICHD NIH HHS U10 HD36790 / NICHD NIH HHS M01 RR8084 / NCRR NIH HHS UL1 TR001449 / NCATS NIH HHS U10 HD40498 / NICHD NIH HHS UL1 TR000454 / NCATS NIH HHS U10 HD021373-24 / NICHD NIH HHS UL1 RR25008 / NCRR NIH HHS U10 HD40492 / NICHD NIH HHS M01 RR007122 / NCRR NIH HHS U10 HD027880-18 / NICHD NIH HHS UG1 HD027851 / NICHD NIH HHS U10 HD34216 / NICHD NIH HHS U10 HD27851 / NICHD NIH HHS U10 HD053119 / NICHD NIH HHS M01 RR125 / NCRR NIH HHS M01 RR006022 / NCRR NIH HHS UG1 HD053109 / NICHD NIH HHS K23 HD041423 / NICHD NIH HHS U10 HD053119-04 / NICHD NIH HHS U10 HD053109 / NICHD NIH HHS U10 HD027856 / NICHD NIH HHS U10 HD27871 / NICHD NIH HHS U10 HD027880 / NICHD NIH HHS U10 HD034216-13 / NICHD NIH HHS U10 HD40689 / NICHD NIH HHS U10 HD021364 / NICHD NIH HHS U10 HD027851 / NICHD NIH HHS U10 HD21385 / NICHD NIH HHS U10 HD40461 / NICHD NIH HHS M01 RR633 / NCRR NIH HHS M01 RR6022 / NCRR NIH HHS U10 HD040492-08 / NICHD NIH HHS M01 RR54 / NCRR NIH HHS U10 HD53124 / NICHD NIH HHS U10 HD27856 / NICHD NIH HHS M01 RR997 / NCRR NIH HHS U10 HD040498-05 / NICHD NIH HHS UL1 TR000041 / NCATS NIH HHS M01 RR16587 / NCRR NIH HHS U10 HD27880 / NICHD NIH HHS M01 RR008084 / NCRR NIH HHS UL1 RR24979 / NCRR NIH HHS UL1 RR25744 / NCRR NIH HHS M01 RR016587 / NCRR NIH HHS U10 HD27904 / NICHD NIH HHS U10 HD027856-18 / NICHD NIH HHS M01 RR32 / NCRR NIH HHS U10 HD027851-18 / NICHD NIH HHS M01 RR7122 / NCRR NIH HHS U10 HD027853-18 / NICHD NIH HHS U10 HD27853 / NICHD NIH HHS U10 HD021385-23 / NICHD NIH HHS U10 HD027904 / NICHD NIH HHS M01 RR64 / NCRR NIH HHS U10 HD021364-23 / NICHD NIH HHS M01 RR44 / NCRR NIH HHS UL1 RR24139 / NCRR NIH HHS U10 HD040521-05 / NICHD NIH HHS U10 HD021385 / NICHD NIH HHS UG1 HD034216 / NICHD NIH HHS U10 HD053109-04 / NICHD NIH HHS U10 HD040461 / NICHD NIH HHS UL1 RR024979 / NCRR NIH HHS U10 HD53119 / NICHD NIH HHS U10 HD053124 / NICHD NIH HHS M01 RR80 / NCRR NIH HHS M01 RR59 / NCRR NIH HHS M01 RR000030-45 / NCRR NIH HHS U10 HD53109 / NICHD NIH HHS U10 HD21397 / NICHD NIH HHS U10 HD021397 / NICHD NIH HHS U10 HD036790 / NICHD NIH HHS UL1 RR024139 / NCRR NIH HHS UL1 RR025008 / NCRR NIH HHS U10 HD21364 / NICHD NIH HHS U10 HD027871-18 / NICHD NIH HHS U10 HD027853 / NICHD NIH HHS U10 HD040689-08 / NICHD NIH HHS U10 HD053089-04 / NICHD NIH HHS M01 RR750 / NCRR NIH HHS U10 HD034216 / NICHD NIH HHS U10 HD40521 / NICHD NIH HHS U10 HD040461-05 / NICHD NIH HHS UL1 RR025744 / NCRR NIH HHS U10 HD21373 / NICHD NIH HHS U10 HD027904-18 / NICHD NIH HHS U10 HD036790-12 / NICHD NIH HHS M01 RR30 / NCRR NIH HHS
Language: English
Date published: 05/27/2010
Academic Unit: Stead Family Department of Pediatrics; Neonatology
Record Identifier: 9984093473402771

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