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- W3208595514 abstract "To characterize the safety of sildenafil in premature infants. 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. 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. 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. ClinicalTrials.gov Identifier: NCT01670136." @default.
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- W3208595514 date "2021-11-05" @default.
- W3208595514 modified "2023-10-15" @default.
- W3208595514 title "Safety of sildenafil in extremely premature infants: a phase I trial" @default.
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- W3208595514 doi "https://doi.org/10.1038/s41372-021-01261-w" @default.
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