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

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

Morgan D Lane  1 , Sujata Kishnani  1 , Obianuju Udemadu  1 , Samuel Eshun Danquah  1 , Robert M Treadway 3rd  1 , Aaliyah Langman  1 , Stephen Balevic  1   2 , Wesley M Jackson  3 , Matthew Laughon  3 , Christoph P Hornik  1   2 , Rachel G Greenberg  1   2 , Reese H Clark  4 , Kanecia O Zimmerman  5   6
Affiliations

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

Morgan D Lane et al. J Perinatol. 2021 Nov.

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.

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Conflict of interest statement

MDL: research support from Duke BIGGER Program. SB: support from the National Institutes of Health, FDA, PCORI, the Rheumatology Research Foundation’s Scientist Development Award, the Thrasher Research Fund, the Childhood Arthritis and Rheumatology Research Alliance, and consulting for UCB. KOZ: support from the National Institutes of Health (National Institute of Child Health and Human Development (K23 HD091398, HHSN275201000003I), the US FDA (UG3/UH3 FD 006797), the Duke Clinical and Translational Science Award (KL2TR001115-03), and industry for neonatal and pediatric drug development (www.dcri.duke.edu/research/coi.jsp). All other authors report no competing interests relevant to this paper.

Figures

Fig. 1
Fig. 1. Surfactant trends.
Overall and late surfactant trends.
Fig. 2
Fig. 2. Administration trend over time.
Late surfactant administration trend over time.
Fig. 3
Fig. 3. Administration by site.
Late surfactant administration by site.
See this image and copyright information in PMC

References

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