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

Abstract

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.

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Jackson W, Gonzalez D, Smith PB, et al. Safety of sildenafil in extremely premature infants: a phase I trial. J Perinatol. 2022;42(1):31-36. doi:10.1038/s41372-021-01261-w
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Journal of Perinatology
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