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. 2019 May:208:163-168.
doi: 10.1016/j.jpeds.2018.11.041. Epub 2018 Dec 21.

Surfactant Administration in Preterm Infants: Drug Development Opportunities

Genevieve Taylor  1 , Wesley Jackson  2 , Christoph P Hornik  3 , Alec Koss  4 , Sreekar Mantena  4 , Kenya Homsley  4 , Blair Gattis  4 , Menefese Kudumu-Clavell  4 , Reese Clark  5 , P Brian Smith  3 , Matthew M Laughon  2
Affiliations

Surfactant Administration in Preterm Infants: Drug Development Opportunities

Genevieve Taylor et al. J Pediatr. 2019 May.

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 older GA than those who received surfactant on-label (35 191 [32%]), or were treated with intubation and surfactant administration followed by immediate extubation (INSURE) (32 310 [29%]). Poractant alfa was administered via INSURE more frequently than beractant or calfactant (16 688 [38%], 7137 [20%], and 8485 [27%], respectively). An increasing number of infants received surfactant via INSURE from 2005 to 2015 (from 1697 [19%] to 3368 [36%]).

Conclusions: The majority of surfactant given to preterm infants is administered off-label. The uptrend in administration via INSURE coincides with increased supporting evidence. The gap between FDA labeling and current clinic practice exemplifies an opportunity for label expansion, which may require additional prospective or retrospective safety and/or effectiveness data for infants of older GA and higher birth weight.

Keywords: drug development; surfactant.

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Figures

FIGURE:
FIGURE:
Percentage Surfactant Administered Off-label to Preterm Infants by Year *Poractant alfa label does not specify gestational age
See this image and copyright information in PMC

Comment in

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