Trial reportThe New England journal of medicine2013
Oxygen saturation and outcomes in preterm infants.
Trial report in The New England journal of medicine, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 4 registered trials, which are not on this map. Cited by 179 papers, 13 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Monitoring of Cerebral and Abdominal Tissue Oxygen Saturation in Neonates
Strategy to Avoid Excessive Oxygen for Critically Ill Trauma Patients (SAVE-O2)
Strategy to Avoid Excessive Oxygen in Major Burn Patients (SAVE-O2)
Iron, Transferrin and Retinopathy of Prematurity (ROP): Towards New Pathophysiological Mechanisms.
Who cites it
179 citing papers in PubMed, 13 syntheses or guidelines pooled it, 502 citations in OpenAlex.
- Automated oxygen delivery for preterm infants with respiratory dysfunction.The Cochrane database of systematic reviews · 2023Pooled it
- Interventions to Reduce Severe Brain Injury Risk in Preterm Neonates: A Systematic Review and Meta-analysis.JAMA network open · 2023Pooled it
- Eligibility Criteria and Representativeness of Randomized Clinical Trials That Include Infants Born Extremely Premature: A Systematic Review.The Journal of pediatrics · 2021Pooled it
- Lung recruitment manoeuvres for reducing mortality and respiratory morbidity in mechanically ventilated neonates.The Cochrane database of systematic reviews · 2021Pooled it
- Pooled it
- Pooled it
- Effects of targeting lower versus higher arterial oxygen saturations on death or disability in preterm infants.The Cochrane database of systematic reviews · 2017Pooled it
- Oxygen saturation targeting by pulse oximetry in the extremely low gestational age neonate: a quixotic quest.Current opinion in pediatrics · 2017Pooled it
- Oxygen Saturation Targets in Preterm Infants and Outcomes at 18-24 Months: A Systematic Review.Pediatrics · 2017Pooled it
- Usual Care and Informed Consent in Clinical Trials of Oxygen Management in Extremely Premature Infants.PloS one · 2016Pooled it
- Compliance in oxygen saturation targeting in preterm infants: a systematic review.European journal of pediatrics · 2015Pooled it
- Oxygen saturation target range for extremely preterm infants: a systematic review and meta-analysis.JAMA pediatrics · 2015Pooled it
- Preterm-associated visual impairment and estimates of retinopathy of prematurity at regional and global levels for 2010.Pediatric research · 2013Pooled it
- Conservative versus liberal oxygenation targets in critically ill children: the Oxy-PICU RCT.Health technology assessment (Winchester, England) · 2026Trial
- Comparison of two devices for automated oxygen control in preterm infants: a randomised crossover trial.Archives of disease in childhood. Fetal and neonatal edition · 2022Trial
- Two speeds of increasing milk feeds for very preterm or very low-birthweight infants: the SIFT RCT.Health technology assessment (Winchester, England) · 2020Trial
- rhIGF-1/rhIGFBP-3 in Preterm Infants: A Phase 2 Randomized Controlled Trial.The Journal of pediatrics · 2019Trial
- An international comparison of retinopathy of prematurity grading performance within the Benefits of Oxygen Saturation Targeting II trials.Eye (London, England) · 2018Trial
- Patterns of Oxygenation, Mortality, and Growth Status in the Surfactant Positive Pressure and Oxygen Trial Cohort.The Journal of pediatrics · 2017Trial
- Early Cumulative Supplemental Oxygen Predicts Bronchopulmonary Dysplasia in High Risk Extremely Low Gestational Age Newborns.The Journal of pediatrics · 2016Trial
119 more citing papers are in PubMed but not listed here.
Corrections and comments
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Authors and funding
31 authors at 1 institution in 1 country.
Funding
Abstract
backgroundThe 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.
methodsIn 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.
resultsA 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.
conclusionsTargeting 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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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.