In preterm babies with confirmed respiratory distress syndrome, the effectiveness, and safety of nebulized poractant alfa (at 200 and 400 mg/kg dosages) administered in conjunction with nasal continuous positive airway pressure were compared to nasal continuous positive airway pressure alone.

The newborns in this randomized, controlled, international trial ranged in gestational age from 280/7 to 326/7 weeks. The primary outcome was the occurrence of respiratory failure within the first 72 hours of birth, defined as the necessity for endotracheal surfactant and/or mechanical ventilation due to predefined criteria. The time to respiratory failure in the first 72 hours, the length of ventilation, death, the incidence of bronchopulmonary dysplasia, and significant related newborn comorbidities were all secondary outcomes.

Furthermore, the therapies’ safety and tolerability were evaluated by reporting the number and percentage of babies who experienced treatment-emergent adverse events and adverse drug responses during nebulization.

A total of 129 newborns were randomly assigned. The primary outcome showed no significant differences: 24 (57%), 20 (49%), and 25 (58%) infants received endotracheal surfactant and/or mechanical ventilation within 72 hours in the poractant alfa 200 mg/kg, poractant alfa 400 mg/kg, and nasal continuous positive airway pressure groups, respectively. Similarly, there were no differences in secondary respiratory outcomes across groups. Enrollment was ended early due to a shift in the intervention’s benefit-risk balance. The trial therapy, nebulized poractant alfa, was well-tolerated and safe, with no significant side effects.

The intervention had no effect on the risk of developing respiratory failure within the first 72 hours of life.

Reference: jpeds.com/article/S0022-3476(22)00175-5/fulltext