Safety of Enalapril in Infants Admitted to the Neonatal Intensive Care Unit.

Journal Article (Journal Article)

Enalapril is used to treat hypertension and congestive heart failure in infants. However, enalapril is not labeled for neonates, and safety data in infants are sparse. To evaluate the safety of enalapril in young infants, we conducted a retrospective cohort study of infants who were exposed to enalapril in the first 120 days of life and were cared for in 348 neonatal intensive care units from 1997 to 2012. We determined the proportion of exposed infants who developed adverse events, including death, hypotension requiring pressors, hyperkalemia, and elevated serum creatinine. Using multivariable logistic regression, we examined risk factors for adverse events, including postnatal age at first exposure, exposure duration, gestational age group, small for gestational age status, race, sex, 5-min Apgar score, and inborn status. Of a cohort of 887,910 infants, 662 infants (0.07%) were exposed to enalapril. Among exposed infants, 142 infants (21%) suffered an adverse event. The most common adverse event was hyperkalemia (13%), followed by elevated serum creatinine (5%), hypotension (4%), and death (0.5%). Significant risk factors for adverse events included postnatal age <30 days at first exposure and longer exposure duration. This study is the largest to date examining the safety of enalapril in young term and preterm infants without significant structural cardiac disease.

Full Text

Duke Authors

Cited Authors

  • Ku, LC; Zimmerman, K; Benjamin, DK; Clark, RH; Hornik, CP; Smith, PB; Best Pharmaceuticals for Children Act – Pediatric Trials Network Steering Committee,

Published Date

  • January 2017

Published In

Volume / Issue

  • 38 / 1

Start / End Page

  • 155 - 161

PubMed ID

  • 27826711

Pubmed Central ID

  • PMC5288129

Electronic International Standard Serial Number (EISSN)

  • 1432-1971

Digital Object Identifier (DOI)

  • 10.1007/s00246-016-1496-2


  • eng

Conference Location

  • United States