Aerosolized Beractant in neonatal respiratory distress syndrome: A randomized fixed-dose parallel-arm phase II trial

• Published in: Pulmonary pharmacology & therapeutics 2021-02, Vol.66, p.101986-101986, Article 101986
• Main Authors: Sood, Beena G., Thomas, Ronald, Delaney-Black, Virginia, Xin, Yuemin, Sharma, Amit, Chen, Xinguang
• Format: Article
• Language: English
• Subjects: Aerosol; Nebulizer; Non-invasive respiratory support; Prematurity; Respiratory distress syndrome; Surfactant
• ISSN: 1094-5539; 1522-9629
• DOI: 10.1016/j.pupt.2020.101986

There is increasing research into novel techniques of administering surfactant to preterm infants (PTIs) with respiratory distress syndrome (RDS) receiving non-invasive respiratory support (NIRS). Although aerosolized surfactant (AS) is promising in PTIs receiving NIRS, the optimal surfactant dose and formulation, drug-device combination and patient profile is not known. The objective of this randomized clinical trial was to investigate the feasibility, safety, efficacy and impact of four dosing schedules of AS using two nebulizers in PTIs with RDS stratified by gestational age (GA). PTIs with RDS receiving pre-defined NIRS for ≤8 h were assigned to 4 A S dosing schedules and 2 nebulizers within three GA strata (I = 240/7-286/7, II = 290/7-326/7, III = 330/7-366/7 weeks). There was no contemporaneous control group; at the recommendation of the Data Monitoring Committee, data was collected retrospectively for control infants. Of 149 subjects that received AS, the median age at initiation of the 1st dose and duration was 5.5 and 2.4 h respectively. There were 29 infants in stratum I, and 60 each in strata II and III. Of infants