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Oxygen saturation and outcomes in preterm infants
Insights
Targeting lower oxygen saturation (85-89%) in extremely preterm infants increased mortality risk. While it reduced retinopathy of prematurity, it also raised necrotizing enterocolitis rates, indicating a complex risk-benefit balance.
Area of Science:
- Neonatalogy
- Clinical Trials
- Pediatric Critical Care
Background:
- The optimal oxygen saturation range for preterm infants remains undefined.
- Previous research suggested lower oxygen saturation targets may decrease retinopathy of prematurity rates.
Purpose of the Study:
- To evaluate the impact of targeting lower oxygen saturation (85-89%) versus higher saturation (91-95%) on disability-free survival in extremely preterm infants.
- To analyze hospital discharge outcomes in infants born before 28 weeks' gestation.
Main Methods:
- Three international randomized controlled trials involving 2448 preterm infants were analyzed.
- Oxygen saturation targeting groups were 85-89% versus 91-95%.
- Oximeter-calibration algorithm was revised mid-study, and data were pooled for analysis.
Main Results:
- With a revised oximeter algorithm, the lower oxygen saturation target group had a significantly higher mortality rate (23.1% vs. 15.9%).
- Overall, lower oxygen saturation targets reduced retinopathy of prematurity (10.6% vs. 13.5%) but increased necrotizing enterocolitis (10.4% vs. 8.0%).
- Mortality showed heterogeneity between original and revised oximeter algorithms (P=0.006).
Conclusions:
- Targeting oxygen saturation below 90% in extremely preterm infants using current oximeters is linked to an increased risk of death.
- The findings highlight a critical trade-off between reducing retinopathy of prematurity and increasing risks of mortality and necrotizing enterocolitis.
Background:
The clinically appropriate range for oxygen saturation in preterm infants is unknown. Previous studies have shown that infants had reduced rates of retinopathy of prematurity when lower targets of oxygen saturation were used.
Methods:
In three international randomized, controlled trials, we evaluated the effects of targeting an oxygen saturation of 85 to 89%, as compared with a range of 91 to 95%, on disability-free survival at 2 years in infants born before 28 weeks' gestation. Halfway through the trials, the oximeter-calibration algorithm was revised. Recruitment was stopped early when an interim analysis showed an increased rate of death at 36 weeks in the group with a lower oxygen saturation. We analyzed pooled data from patients and now report hospital-discharge outcomes.
Results:
A total of 2448 infants were recruited. Among the 1187 infants whose treatment used the revised oximeter-calibration algorithm, the rate of death was significantly higher in the lower-target group than in the higher-target group (23.1% vs. 15.9%; relative risk in the lower-target group, 1.45; 95% confidence interval [CI], 1.15 to 1.84; P=0.002). There was heterogeneity for mortality between the original algorithm and the revised algorithm (P=0.006) but not for other outcomes. In all 2448 infants, those in the lower-target group for oxygen saturation had a reduced rate of retinopathy of prematurity (10.6% vs. 13.5%; relative risk, 0.79; 95% CI, 0.63 to 1.00; P=0.045) and an increased rate of necrotizing enterocolitis (10.4% vs. 8.0%; relative risk, 1.31; 95% CI, 1.02 to 1.68; P=0.04). There were no significant between-group differences in rates of other outcomes or adverse events.
Conclusions:
Targeting an oxygen saturation below 90% with the use of current oximeters in extremely preterm infants was associated with an increased risk of death. (Funded by the Australian National Health and Medical Research Council and others; BOOST II Current Controlled Trials number, ISRCTN00842661, and Australian New Zealand Clinical Trials Registry numbers, ACTRN12605000055606 and ACTRN12605000253606.).
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