Prophylactic or early selective surfactant combined with nCPAP in very preterm infants

Respiratory distress syndrome (RDS) and mechanical ventilation (MV) are major determinants of bronchopulmonary dysplasia (BPD). Surfactant treatment has changed the natural history of RDS, resulting in a 30% to 65% relative reduction in risk for pneumothorax and up to a 40% relative reduction in neonatal mortality, with a favourable tolerability profile. However, the results of randomized, controlled trials have demonstrated that prophylactic or early surfactant therapy improves clinical outcomes for preterm infants at high risk when compared with delayed rescue surfactant treatment.
Nasal continuous positive airway pressure (nCPAP) is an important respiratory support in newborns. nCPAP followed by intubation and surfactant administration may reduce the need for MV and the incidence of BPD. The intubation-surfactant-extubation (InSurE) method consists in a brief intubation for surfactant administration followed by quick extubation to nCPAP. This approach has been investigated and resulted in a reduced need for MV in the first week of life when used early in RDS. Prophylactic surfactant and delivery room nCPAP to maintain functional residual volume have been identified as potentially beneficial practices that, if adopted for extremely preterm infants, could reduce lung injury. However, no randomized clinical trials have yet compared prophylactic surfactant with early nCPAP, especially in extremely preterm infants at high risk for developing RDS.
On this basis, an international randomized controlled trial was designed to compare the administration of prophylactic surfactant followed by nCPAP with early nCPAP followed by early selective surfactant and assess the need for MV in the first 5 days of life.
A total of 208 preterm infants ( 25 to 28 weeks’ GA) who were not intubated at birth were randomly assigned to prophylactic surfactant or nCPAP within 30 minutes of birth. Surfactant administration in both arms was followed by extubation to nCPAP as soon as possible (within 1 hour).
Overall, 33 (31.4%) infants in the prophylactic surfactant group needed MV in the first 5 days of life, compared with 34 (33.0%) in the nCPAP group (risk ratio (RR): 0.95 [95% confidence interval, 95% CI: 0.64 –1.41]; P=0.80). Death and type of survival at 28 days of life and 36 weeks’ postmenstrual age and incidence of main morbidities of prematurity (secondary outcomes) were similar in the 2 groups. A total of 78.1% of infants in the prophylactic surfactant group and 78.6% in the nCPAP group survived in room air at 36 weeks’ postmenstrual age.
This study underlines that nCPAP should be started soon after birth in spontaneously breathing infants of 25 to 28 weeks’ GA and early selective surfactant should be given once signs of respiratory distress have developed. With this strategy, >50% of infants will need only nCPAP, 48.5% will need intubation and surfactant, and nearly one-third will need MV in the first 5 days of life. In addition, this approach resulted in a low incidence of moderate-to-severe BDP (12 to 14%) and in a low need for a second dose of surfactant (11 to 13%).

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