Surfactant Administration in Preterm Infants: Drug Development Opportunities.

ABSTRACT:

Objective

To evaluate how frequently surfactant is used off-label in preterm infants.

Study design

We conducted a retrospective cohort analysis of prospectively collected administrative data for 2005-2015 from 348 neonatal intensive care units in the US. We quantified off-label administration of poractant alfa, calfactant, or beractant in inborn infants born at <37 weeks of gestational age (GA). Off-label surfactant administration was defined according to the Food and Drug Administration (FDA) label.

Results

Of a total of 110 822 preterm infants who received surfactant, 68 226 (62%) received the surfactant off-label. The majority of infants who received surfactant off-label had a higher birth weight than those who received surfactant on-label (40 716 [37%]), had an ol

SUBMITTER: Taylor G 

PROVIDER: S-EPMC6486873 | biostudies-literature | 2019 May

REPOSITORIES: biostudies-literature