Neurodevelopmental Outcomes in the Early CPAP and Pulse Oximetry Trial

Abstract

BACKGROUND Previous results from our trial of early treatment with continuous positive airway pressure (CPAP) versus early surfactant treatment in infants showed no significant difference in the outcome of death or bronchopulmonary dysplasia. A lower (vs. higher) target range of oxygen saturation was associated with a lower rate of severe retinopathy but higher mortality. We now report longer-term results from our prespecified hypotheses. METHODS Using a 2-by-2 factorial design, we randomly assigned infants born between 24 weeks 0 days and 27 weeks 6 days of gestation to early CPAP with a limited ventilation strategy or early surfactant administration and to lower or higher target ranges of oxygen saturation (85 to 89% or 91 to 95%). The primary composite outcome for the longer-term analysis was death before assessment at 18 to 22 months or neurodevelopmental impairment at 18 to 22 months of corrected age. RESULTS The primary outcome was determined for 1234 of 1316 enrolled infants (93.8%); 990 of the 1058 surviving infants (93.6%) were evaluated at 18 to 22 months of corrected age. Death or neurodevelopmental impairment occurred in 27.9% of the infants in the CPAP group (173 of 621 infants), versus 29.9% of those in the surfactant group (183 of 613) (relative risk, 0.93; 95% confidence interval [CI], 0.78 to 1.10; P = 0.38), and in 30.2% of the infants in the lower-oxygen-saturation group (185 of 612), versus 27.5% of those in the higher-oxygen-saturation group (171 of 622) (relative risk, 1.12; 95% CI, 0.94 to 1.32; P = 0.21). Mortality was increased with the lower-oxygen-saturation target (22.1%, vs. 18.2% with the higher-oxygen-saturation target; relative risk, 1.25; 95% CI, 1.00 to 1.55; P = 0.046). CONCLUSIONS We found no significant differences in the composite outcome of death or neurodevelopmental impairment among extremely premature infants randomly assigned to early CPAP or early surfactant administration and to a lower or higher target range of oxygen saturation. (Funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development and the National Heart, Lung, and Blood Institute; SUPPORT ClinicalTrials.gov number, NCT00233324.)

Improving Delivery Room Management for Very Preterm Infants

“…24 Increasing evidence suggests that outcomes of infants who are managed with delivery room CPAP are at least equal to, and potentially better than, outcomes of those who are immediately intubated. 27,31,33,34 Despite the lack of a statistically significant decrease in delivery room intubations, our results are similar to previous studies that demonstrated associations between increased use of delivery room CPAP and decreased duration of mechanical ventilation or oxygen dependence. 27,31 One explanation for these results could be that the QI intervention was associated with a culture shift toward decreased dependence on endotracheal intubation and increased use of noninvasive support throughout the hospitalization.…”

“…This is consistent with the SUPPORT Trial, in which the rate of epinephrine use was 4.1% in the intubation/surfactant group and only 2.0% in the CPAP group, and could have led to improved patient outcomes. 33 There are several potential reasons that we have not yet observed a statistically significant decrease in the number of infants intubated in the delivery room, despite the increased use of CPAP. It is possible that our sample size was too small to detect differences in this outcome.…”

Respiratory support for premature neonates in the delivery room: effects on cardiovascular function and the development of brain injury

“…showed that very-lowbirth-weight infants who received cardiopulmonary resuscitation had increased mortality and higher rates of IVH compared with infants who did not require resuscitation. Trials that have compared early continuous positive airway pressure vs. early surfactant and intubation treatment have shown trends for higher rates of bronchopulmonary dysplasia or death in the intubated groups (76,77) but have failed to find differences in neurodevelopmental outcomes (78). Indeed, studies in preterm lambs have also found no difference in terms of lung and systemic inflammation and injury between continuous positive airway pressure and PPV (79); therefore, the findings from these trials are not surprising.…”

Oxygen Saturation Targets in Preterm Infants and Outcomes at 18–24 Months: A Systematic Review

“…10 The 18-to 24-month results for the outcome of death/ NDI in SUPPORT were published in 2012. 22 The 2-year outcome for the composite of death/disability was published for BOOST-II New Zealand in 2014 23 and for the United Kingdom/Australia in 2016. 15 …”