In a randomised, multicentre trial of 1316 infants born between 24 weeks 0 days and 27 weeks 6 days of gestation, infants were randomly assigned to intubation and surfactant treatment (within 1 hour after birth) or to CPAP treatment initiated in the delivery room, with subsequent use of a protocol-driven limited ventilation strategy. The primary outcome was death or bronchopulmonary dysplasia as defined by the requirement for supplemental oxygen at 36 weeks.
Infants who received CPAP treatment, as compared with infants who received surfactant treatment, less frequently required intubation or postnatal corticosteroids for bronchopulmonary dysplasia (P<0.001), required fewer days of mechanical ventilation (P=0.03), and were more likely to be alive and free from the need for mechanical ventilation by day 7 (P=0.01). However the rates of the primary outcome did not differ significantly between the CPAP group and the surfactant group (47.8% and 51.0%, respectively; relative risk with CPAP, 0.95; 95% confidence interval [CI], 0.85 to 1.05).
The infants randomised to CPAP could receive limited invasive ventilation if necessary; 83.1% of the infants in the CPAP group were intubated. They did not include infants who were born at a gestational age of less than 24 weeks, since the results of a pilot trial showed that 100% of such infants required intubation in the delivery room.
This study had a 2-by-2 factorial design in which infants were also randomly assigned to one of two target ranges of oxygen saturation.
Early CPAP versus Surfactant in Extremely Preterm Infants
N Engl J Med. 2010 May 16. [Epub ahead of print]