Sildenafil Exposure in the Neonatal Intensive Care Unit.

Journal Article (Journal Article)

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.

Full Text

Duke Authors

Cited Authors

  • Thompson, EJ; Perez, K; Hornik, CP; Smith, PB; Clark, RH; Laughon, M; Best Pharmaceuticals for Children Act—Pediatric Trials Network Steering Committee,

Published Date

  • February 2019

Published In

Volume / Issue

  • 36 / 3

Start / End Page

  • 262 - 267

PubMed ID

  • 30081404

Pubmed Central ID

  • PMC6996478

Electronic International Standard Serial Number (EISSN)

  • 1098-8785

Digital Object Identifier (DOI)

  • 10.1055/s-0038-1667378


  • eng

Conference Location

  • United States