Aerosolized Calfactant for Newborns With Respiratory Distress: A Randomized Trial

Area of Science:

• Neonatal Medicine
• Pulmonology
• Pharmacology

Background:

• Current exogenous surfactant treatments for respiratory distress syndrome (RDS) require tracheal instillation, necessitating intubation and positive pressure ventilation.
• Aerosol delivery of surfactants presents a potentially safer alternative, but clinical evidence has been inconsistent.
• This study investigated the efficacy of aerosolized calfactant for early RDS management.

Purpose of the Study:

• To evaluate if aerosolized calfactant could decrease the requirement for intubation and liquid surfactant instillation in newborns with early signs of RDS.
• To compare the rates of intubation and surfactant instillation between infants receiving aerosolized calfactant and those receiving usual care.

Main Methods:

• A prospective, multicenter, randomized trial involving newborns with RDS requiring noninvasive support.
• Calfactant was administered via aerosol using a modified nebulizer with a pacifier adapter (6 mL/kg).
• Infants received up to 3 aerosol treatments, with controls receiving standard care; intubation decisions were provider-dependent.

Main Results:

• 457 infants were enrolled; 230 were assigned to the aerosol group.
• Intubation rates for surfactant instillation were 26% in the aerosol group versus 50% in the usual care group (P < .0001).
• No significant differences in respiratory outcomes up to 28 days of age were observed between groups.

Conclusions:

• Aerosolized calfactant administration significantly reduced the need for intubation and surfactant instillation in newborns with early, mild to moderate RDS.
• This approach nearly halved the rate of intubation and instillation compared to usual care.
• Aerosol delivery of calfactant shows promise as a less invasive treatment strategy for neonatal respiratory distress.