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

J Perinatol. 2021 Nov;41(11):2639-2644. doi: 10.1038/s41372-021-01142-2. Epub 2021 Jul 20.

Abstract

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.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Biological Products* / adverse effects
  • Humans
  • Infant, Newborn
  • Infant, Premature
  • Phospholipids
  • Pulmonary Surfactants* / adverse effects
  • Respiratory Distress Syndrome, Newborn* / drug therapy
  • Retrospective Studies
  • Surface-Active Agents / adverse effects

Substances

  • Biological Products
  • Phospholipids
  • Pulmonary Surfactants
  • Surface-Active Agents