Scholars@Duke publication: Safety of sildenafil in extremely premature infants: a phase I trial.

Safety of sildenafil in extremely premature infants: a phase I trial.

Publication , Journal Article

Jackson, W; Gonzalez, D; Smith, PB; Ambalavanan, N; Atz, AM; Sokol, GM; Hornik, CD; Stewart, D; Mundakel, G; Poindexter, BB; Ahlfeld, SK ...

Published in: J Perinatol

January 2022

Published version (DOI) Link to item

OBJECTIVE: To characterize the safety of sildenafil in premature infants. STUDY DESIGN: A phase I, open-label trial of sildenafil in premature infants receiving sildenafil per usual clinical care (cohort 1) or receiving a single IV dose of sildenafil (cohort 2). Safety was evaluated based on adverse events (AEs), transaminase levels, and mean arterial pressure monitoring. RESULTS: Twenty-four infants in cohort 1 (n = 25) received enteral sildenafil. In cohort 2, infants received a single IV sildenafil dose of 0.25 mg/kg (n = 7) or 0.125 mg/kg (n = 2). In cohort 2, there was one serious AE related to study drug involving hypotension associated with a faster infusion rate than specified by the protocol. There were no AEs related to elevated transaminases. CONCLUSION: Sildenafil was well tolerated by the study population. Drug administration times and flush rates require careful attention to prevent infusion-related hypotension associated with faster infusions of IV sildenafil in premature infants. CLINICAL TRIAL: ClinicalTrials.gov Identifier: NCT01670136.

Duke Scholars

Author Daniel Gonzalez Medicine, Clinical Pharmacology

Author Phillip Brian Smith Pediatrics, Neonatology

Author Chi Hornik Pediatrics, Critical Care Medicine

Author Michael Cohen-Wolkowiez Pediatrics, Infectious Diseases

Author Christoph Paul Vincent Hornik Pediatrics, Critical Care Medicine

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Published In

J Perinatol

DOI

10.1038/s41372-021-01261-w

EISSN

1476-5543

Publication Date

January 2022

Volume

Issue

Start / End Page

31 / 36

Location

United States

Related Subject Headings

Sildenafil Citrate
Pediatrics
Infant, Premature, Diseases
Infant, Newborn
Infant, Low Birth Weight
Infant, Extremely Premature
Hypotension
Humans
3213 Paediatrics
1114 Paediatrics and Reproductive Medicine

Citation

APA

Chicago

ICMJE

MLA

NLM

Jackson, W., Gonzalez, D., Smith, P. B., Ambalavanan, N., Atz, A. M., Sokol, G. M., … Best Pharmaceuticals for Children Act—Pediatric Trials Network Steering Committee. (2022). Safety of sildenafil in extremely premature infants: a phase I trial. J Perinatol, 42(1), 31–36. https://doi.org/10.1038/s41372-021-01261-w

Jackson, Wesley, Daniel Gonzalez, P Brian Smith, Namasivayam Ambalavanan, Andrew M. Atz, Gregory M. Sokol, Chi D. Hornik, et al. “Safety of sildenafil in extremely premature infants: a phase I trial.” J Perinatol 42, no. 1 (January 2022): 31–36. https://doi.org/10.1038/s41372-021-01261-w.

Jackson W, Gonzalez D, Smith PB, Ambalavanan N, Atz AM, Sokol GM, et al. Safety of sildenafil in extremely premature infants: a phase I trial. J Perinatol. 2022 Jan;42(1):31–6.

Jackson, Wesley, et al. “Safety of sildenafil in extremely premature infants: a phase I trial.” J Perinatol, vol. 42, no. 1, Jan. 2022, pp. 31–36. Pubmed, doi:10.1038/s41372-021-01261-w.

Jackson W, Gonzalez D, Smith PB, Ambalavanan N, Atz AM, Sokol GM, Hornik CD, Stewart D, Mundakel G, Poindexter BB, Ahlfeld SK, Mills M, Cohen-Wolkowiez M, Martz K, Hornik CP, Laughon MM, Best Pharmaceuticals for Children Act—Pediatric Trials Network Steering Committee. Safety of sildenafil in extremely premature infants: a phase I trial. J Perinatol. 2022 Jan;42(1):31–36.

Published In

J Perinatol

DOI

10.1038/s41372-021-01261-w

EISSN

1476-5543

Publication Date

January 2022

Volume

Issue

Start / End Page

31 / 36

Location

United States

Related Subject Headings

Sildenafil Citrate
Pediatrics
Infant, Premature, Diseases
Infant, Newborn
Infant, Low Birth Weight
Infant, Extremely Premature
Hypotension
Humans
3213 Paediatrics
1114 Paediatrics and Reproductive Medicine