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A Model to Simulate Clinically Relevant Hypoxia in Humans
Published on: December 22, 2016
Target ranges of oxygen saturation in extremely preterm infants
Insights
A lower oxygen saturation range (85-89%) for preterm infants did not reduce the combined risk of severe retinopathy or death. However, it increased mortality while significantly decreasing severe retinopathy in survivors.
Area of Science:
- Neonatal Medicine
- Ophthalmology
- Clinical Trials
Background:
- Previous research suggests lower oxygenation may reduce retinopathy in preterm infants.
- Optimal oxygen saturation levels to prevent retinopathy without adverse effects remain unclear.
Purpose of the Study:
- To compare the effects of two target oxygen saturation ranges (85-89% vs. 91-95%) on severe retinopathy of prematurity and mortality in extremely preterm infants.
Main Methods:
- A randomized 2x2 factorial trial involving 1316 infants born between 24 and 27 weeks gestation.
- Primary outcome: composite of severe retinopathy of prematurity, death before discharge, or both.
- Infants were randomized to either a lower (85-89%) or higher (91-95%) oxygen saturation target range.
Main Results:
- No significant difference in the composite outcome of severe retinopathy or death between the two groups (28.3% vs. 32.1%).
- Higher mortality observed in the lower oxygen saturation group (19.9% vs. 16.2%).
- Significantly lower rates of severe retinopathy among survivors in the lower oxygen saturation group (8.6% vs. 17.9%).
Conclusions:
- A lower target oxygen saturation range (85-89%) did not significantly reduce the composite outcome of severe retinopathy or death.
- This lower range led to increased mortality but substantially decreased severe retinopathy in surviving infants.
- The observed increase in mortality raises concerns regarding the widespread adoption of lower oxygen saturation targets for preventing retinopathy of prematurity.
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.)
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