Jackson, WesleyGonzalez, DanielSmith, P. BrianAmbalavanan, NamasivayamAtz, Andrew M.Sokol, Gregory M.Hornik, Chi D.Stewart, DanMundakel, GratiasPoindexter, Brenda B.Ahlfeld, Shawn K.Mills, MaryCohen-Wolkowiez, MichaelMartz, KarenHornik, Christoph P.Laughon, Matthew M.2023-04-052023-04-052022-01Jackson 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-whttps://hdl.handle.net/1805/32242This article is made available for unrestricted research re-use and secondary analysis in any form or be any means with acknowledgement of the original source. These permissions are granted for the duration of the World Health Organization (WHO) declaration of COVID-19 as a global pandemic.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.en-USPublic Health EmergencyRespiratory tract diseasesOutcomes researchHypotensionNewborn infantSildenafil citrateArticle