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Am J Perinatol 2019; 36(03): 262-267
DOI: 10.1055/s-0038-1667378
Original Article
Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.

Sildenafil Exposure in the Neonatal Intensive Care Unit

Elizabeth J. Thompson
1   Department of Pediatrics, Duke University Medical Center, Durham, North Carolina
,
Krystle Perez
2   Department of Pediatrics, University of Washington, Seattle, Washington
,
Christoph P. Hornik
3   Department of Pediatrics, Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina
,
P. Brian Smith
3   Department of Pediatrics, Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina
,
Reese H. Clark
4   Pediatrix-Obstetrix Center for Research and Education, Sunrise, Florida
,
Matthew Laughon
2   Department of Pediatrics, University of Washington, Seattle, Washington
5   Division of Neonatal-Perinatal Medicine, UNC Hospital, Chapel Hill, North Carolina
,
on behalf of the Best Pharmaceuticals for Children Act—Pediatric Trials Network Steering Committee› Author Affiliations
Funding This work was funded under the National Institute of Child Health and Human Development contract HHSN2752010000031 for the Pediatric Trials Network. Research reported in this publication was also supported by the National Center for Advancing Translational Sciences of the National Institutes of Health under award number UL1TR001117. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. Dr. Hornik receives salary support for research from the National Center for Advancing Translational Sciences of the National Institutes of Health (UL1TR001117). Dr. Smith receives salary support for research from the National Institutes of Health and the National Center for Advancing Translational Sciences of the National Institutes of Health (UL1TR001117), the National Institute of Child Health and Human Development (HHSN275201000003I and 1R01-HD081044–01), and the Food and Drug Administration (1R18-FD005292–01); he also receives research support from Cempra Pharmaceuticals (subaward to HHS0100201300009C) and industry for neonatal and pediatric drug development (www.dcri.duke.edu/research/coi.jsp). Dr. Laughon receives support from the U.S. government for his work in pediatric and neonatal clinical pharmacology (NHLBI R34 HL124038, PI: Laughon and Government Contract HHSN267200700051C, PI: Benjamin under the Best Pharmaceuticals for Children Act) and from the National Institute of Child Health and Human Development (K23HD068497). The other authors have nothing to disclose.
Further Information

Publication History

02 May 2018

02 July 2018

Publication Date:
06 August 2018 (online)

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Abstract

Objective Pulmonary hypertension causes substantial morbidity and mortality in infants. Although Food and Drug Administration approved to treat pulmonary arterial hypertension in adults, sildenafil is not approved for infants. We sought to describe sildenafil exposure and associated diagnoses and outcomes in infants.

Study Design Retrospective cohort of neonates discharged from more than 300 neonatal intensive care units from 2001 to 2016.

Results Sildenafil was administered to 1,336/1,161,808 infants (0.11%; 1.1 per 1,000 infants); 0/35,977 received sildenafil in 2001 versus 151/90,544 (0.17%; 1.7 per 1,000 infants) in 2016. Among infants <32 weeks' gestational age (GA) with enough data to determine respiratory outcome, 666/704 (95%) had bronchopulmonary dysplasia (BPD). Among infants ≥32 weeks GA, 248/455 (55%) had BPD and 76/552 (14%) were diagnosed with meconium aspiration. Overall, 209/921 (23%) died prior to discharge.

Conclusion The use of sildenafil has increased since 2001. Exposed infants were commonly diagnosed with BPD. Further studies evaluating dosing, safety, and efficacy of sildenafil are needed.

Keywords

premature infant - sildenafil - pulmonary hypertension - bronchopulmonary dysplasia - neonate