Comparative efficacy and safety of late surfactant preparations: a retrospective study.

OBJECTIVE

Characterize the use, efficacy, and safety of poractant alfa and calfactant surfactants compared to beractant in preterm infants receiving late surfactant.

STUDY

DESIGN

We included infants <37 weeks gestational age (GA) discharged from Pediatrix Medical Group-managed neonatal intensive care units (1997-2017). Efficacy and safety outcomes of interest were analyzed.

RESULTS

Of 184,770 infants administered surfactant at any time, 7846 (4.23%) received late surfactant at a median (25th, 75th percentile) PNA of 8 days (3, 22); specifically, 2976 received poractant alfa (38%), 2890 beractant (37%), and 1936 calfactant (25%). We identified no significant differences in composite efficacy or safety outcomes between surfactants in the primary analysis, but 33-36 week GA infants administered poractant alfa had significantly greater odds of developing a safety event.

CONCLUSIONS

Compared to beractant, there is no evidence of overall superior efficacy or safety of poractant alfa.