Nebulized Poractant alfa fails to prevent respiratory failure in RDS infants

Nebulized Poractant alfa, combined with nasal continuous positive airway pressure (nCPAP), does not seem to significantly protect against respiratory failure in premature infants diagnosed with respiratory distress syndrome (RDS), a new study suggests.

Researchers conducted a randomized, controlled, multinational study including 129 RDS infants who were assigned to one of three parallel arms: Poractant alfa 200 mg/kg with nCPAP (n=43), Poractant alfa 400 mg/kg with nCPAP (n=43), or nCPAP alone (n=43). The primary outcome of interest was the incidence of respiratory failure during the first 72 hours of life.

In the intention-to-treat analysis, neither the 200-mg/kg dose (relative risk [RR] ratio, 0.98, 95 percent confidence interval [CI], 0.68–1.42) nor 400-mg/kg dose (RR ratio, 0.84, 95 percent CI, 0.56–1.26) of Poractant alfa resulted in a significant reduction of respiratory failure risk relative to nCPAP alone.

However, post hoc analyses showed that in the subgroup of infants with gestational age ≥31 weeks, the 400-mg/kg dose of Poractant alfa significantly suppressed the risk of respiratory failure within the first 72 hours of life (RR ratio, 0.46, 95 percent CI, 0.22–0.99). A similar effect was reported for the 200-mg/kg dose but failed to reach significance (RR ratio, 0.64, 95 percent CI, 0.30–1.37).

Moreover, Kaplan-Meier analysis revealed that both Poractant alfa doses might have delayed respiratory failure in the participants, though log-rank tests showed that these differences in timing were not statistically significant.