Target ranges of oxygen saturation in extremely preterm infants.
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.)
Carlo
Waldemar A
WA
Finer
Neil N
NN
Walsh
Michele C
MC
Rich
Wade
W
Gantz
Marie G
MG
Laptook
Abbot R
AR
Yoder
Bradley A
BA
Faix
Roger G
RG
Das
Abhik
A
Poole
W Kenneth
WK
Schibler
Kurt
K
Newman
Nancy S
NS
Ambalavanan
Namasivayam
N
Frantz
Ivan D
ID
Piazza
Anthony J
AJ
Sánchez
Pablo J
PJ
Morris
Brenda H
BH
Laroia
Nirupama
N
Phelps
Dale L
DL
Poindexter
Brenda B
BB
Cotten
C Michael
CM
Van Meurs
Krisa P
KP
Duara
Shahnaz
S
Narendran
Vivek
V
Sood
Beena G
BG
O'Shea
T Michael
TM
Bell
Edward F
EF
Ehrenkranz
Richard A
RA
Watterberg
Kristi L
KL
Higgins
Rosemary D
RD
D045422:Continuous Positive Airway Pressure; D005260:Female; D017052:Hospital Mortality; D006801:Humans; D007226:Infant Mortality; D007231:Infant, Newborn; D007234:Infant, Premature / Q000097:blood*; D007442:Intubation, Intratracheal; D053208:Kaplan-Meier Estimate; D008297:Male; D010092:Oximetry; D010100:Oxygen / Q000008:administration & dosage / Q000097:blood*; D010102:Oxygen Inhalation Therapy / Q000009:adverse effects / Q000379:methods*; D016016:Proportional Hazards Models; D011663:Pulmonary Surfactants / Q000627:therapeutic use; D012016:Reference Values; D012178:Retinopathy of Prematurity / Q000453:epidemiology / Q000517:prevention & control*
D011663:Pulmonary Surfactants; D010100:Oxygen
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