Target Ranges of Oxygen Saturation in Extremely Preterm Infants

Abstract

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 loweroxygen-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.) Retinopathy of prematurity is an important cause of blindness and other visual disabilities in preterm infants. The incidence of retinopathy of prematurity was increased with exposure to unrestricted oxygen supplementation in preterm infants in randomized, controlled trials NIH-PA Author ManuscriptNIH-PA Author Manuscript NIH-PA Author Manuscript performed in the 1950s. 1 In the 1960s, this increase resulted in the practice of restricting the fraction of inspired oxygen (FiO 2 ) to no more than 0.50, which was estimated to result in an excess of 16 deaths per case of blindness prevented. 2 More recent data suggest that levels of oxygen saturation previously thought to be at the upper end of the normal range may increase the risk of retinopathy of prematurity as compared with levels at the lower end of the normal range. [3][4][5] Oxygen toxicity may also increase the risk of death, 6,7 bronchopulmonary dysplasia, 8-...

Pulse oximetry values of neonates admitted for care and receiving routine oxygen therapy at a resource‐limited hospital in Kenya

“…Despite several large randomised trials,32, 33, 34 the optimal SpO 2 range to reduce risk of ROP, while optimising survival, remains unclear. A recent post‐hoc analysis of data from two trials found that a target range of 85–89%, versus 91–95%, resulted in significantly increased risks of death or disability at 2 years and death alone 37.…”

“…Based on the best available evidence to balance risks of ROP and mortality at the time of this study,32, 33, 34 target ranges for term and preterm neonates were established in collaboration with Kenyan paediatricians and nurses, which advised values of SpO 2  ≥ 92% for neonates ≥34 weeks and SpO 2 89–93% for neonates <34 weeks. A training package was provided to staff prior to study implementation, which covered the use of the Lifebox and neonatal probe,29, 30 target ranges and oxygen management using available resources.…”

The SafeBoosC Phase II Randomised Clinical Trial: A Treatment Guideline for Targeted Near-Infrared-Derived Cerebral Tissue Oxygenation versus Standard Treatment in Extremely Preterm Infants

“…In drawing up the treatment guideline we used the premise that hypoxia and hyperoxia are risk factors for an adverse outcome in the preterm infant and should be avoided [10,11,12,13,14,15]. In addition to NIRS assessment of the cerebral circulation, a number of other techniques, particularly echocardiography, are used to assess the neonatal transitional circulation and related outcomes [1,16,17,18,19,20,21,22,23,24,25,26,27].…”

“…The first step would be decrease Fi O 2 in case Sa O 2 is above the normal range or high, even in the normal range [11,12,13,14,15]. Additional interventions would be to decrease mean airway pressure [26,75].…”

Effects of Intravitreal Anti-VEGF Therapy on the Clinical Course of Bronchopulmonary Dysplasia

“…A National Institute of Child Health and Development (NICHD) Neonatal Research Network trial (8), as well as a study by Vento et al (9), previously demonstrated a possible pathogenic interaction between ROP and BPD, at least by means of oxygen exposure.…”