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

Journal of Perinatology volume 41, pages 2639–2644 (2021)Cite this article

Subjects

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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Fig. 1: Surfactant trends.
Fig. 2: Administration trend over time.
Fig. 3: Administration by site.

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Funding

Supported by DCRI’s R25 STAR Program (grant #5R25HD076475-07).

Author information

Authors and Affiliations

  1. Duke Clinical Research Institute, Duke University, Durham, NC, USA

    Morgan D. Lane, Sujata Kishnani, Obianuju Udemadu, Samuel Eshun Danquah, Robert M. Treadway III, Aaliyah Langman, Stephen Balevic, Christoph P. Hornik, Rachel G. Greenberg & Kanecia O. Zimmerman

  2. Department of Pediatrics, Duke University, Durham, NC, USA

    Stephen Balevic, Christoph P. Hornik, Rachel G. Greenberg & Kanecia O. Zimmerman

  3. Neonatal-Perinatal Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA

    Wesley M. Jackson & Matthew Laughon

  4. CREQS, MEDNAX, Sunrise, FL, USA

    Reese H. Clark

Authors
  1. Morgan D. Lane
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  2. Sujata Kishnani
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Contributions

Drafting, revising, and final paper preparation: MDL, CPH, and KOZ. Oversight, funding: KOZ. Drafting, review: SK, OU, SED, RMT, AL, SB, and RHC. Initial concept, revising: WMJ, ML, CPH, and KOZ. Statistical analysis: CPH, RGG. Provided data: RHC.

Corresponding author

Correspondence to Kanecia O. Zimmerman.

Ethics declarations

Competing interests

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.

Ethical approval

The Duke IRB approved this study with a waiver of consent.

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SK, OU, SED, RMT, AL: High school or college student affiliated with the Duke Clinical Research Institute’s R25 Summer Training in Academic Research (STAR) Program.

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Lane, M.D., Kishnani, S., Udemadu, O. et al. Comparative efficacy and safety of late surfactant preparations: a retrospective study. J Perinatol 41, 2639–2644 (2021). https://doi.org/10.1038/s41372-021-01142-2

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