The CURPAP study

The use of surfactant for the treatment or prophylaxis of neonatal respiratory distress syndrome (RDS) determines a 30-65% reduction in the risk of pneumothorax and up to a 40% reduction in the risk of mortality, with a good tolerability profile. Evidence from randomized, controlled trials suggests that prophylactic or early surfactant administration results in improved outcomes for high-risk preterm infants as compared with delayed rescue treatment. Prophylactic administration of surfactant may be preferable than rescue treatment, especially in infants <30 weeks of gestation age (GA), since it decreases the risk of pneumothorax, pulmonary interstitial emphysema and neonatal mortality. However, clinical trials have not provided definitive evidence on best timing of surfactant replacement therapy. Moreover, these trials have been conducted in the early 1990s when prenatal steroids were not widespread and noninvasive nasal continuous positive airway pressure (nCPAP) was poorly adopted.
nCPAP is at present time a first-line respiratory support in newborns. Results of several observational studies have shown that nCPAP can reduce the need for mechanical ventilation and the incidence of various adverse outcomes, such as bronchopulmonary dysplasia (BPD), with no increase in mortality. Few randomized trials compared intubation and mechanical ventilation versus early nCPAP (with surfactant administration at various stages of RDS) or different procedures of nasal CPAP application.
Overall, results of these studies did not highlight significant differences.
It has been reported that a newborn assisted by nCPAP could be intubated for a very short time to administer surfactant. The application of this method, named 'INSURE' (Intubation-Surfactant-Extubation), in the early phase of RDS reduces the need for mechanical ventilation in the first week of life. However, its impact on mortality or morbidity in very-low-birth-weight infants (VLBWI) is still unproven.
On the basis of these evidences, it may be suggested that both surfactant administration within the first 30 min of life and nCPAP application can be strongly recommended in VLBWI at high risk of RDS. The CURPAP multinational study has been designed to compare two different approaches in this population: early stabilization on nasal CPAP and rescue surfactant versus intubation, prophylactic surfactant administration shortly after delivery, followed by rapid extubation to nasal CPAP. CURPAP will include preterm neonates at 25+0 -28+6 GA and with no need for endotracheal intubation. The primary endpoint of this study is the incidence of preterm babies who need mechanical ventilation within the first 5 days of life. The secondary objectives are the safety and overall clinical outcome in terms of mortality rate, incidence of pneumothorax and BPD at 36 weeks, and incidence of other complications related to prematurity and RDS. CURPAP is currently ongoing, and 208 newborns are planned to be randomized within the first quarter of 2008. The results of CURPAP will give useful indications about the optimal respiratory strategy to adopt in high-risk, extremely low-gestational-age neonates.

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