Browsing by Author "Mundakel, Gratias"

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    Safety of sildenafil in extremely premature infants: a phase I trial
    (Springer Nature, 2022-01) Jackson, Wesley; Gonzalez, Daniel; Smith, P. Brian; Ambalavanan, Namasivayam; Atz, Andrew M.; Sokol, Gregory M.; Hornik, Chi D.; Stewart, Dan; Mundakel, Gratias; Poindexter, Brenda B.; Ahlfeld, Shawn K.; Mills, Mary; Cohen-Wolkowiez, Michael; Martz, Karen; Hornik, Christoph P.; Laughon, Matthew M.; Pediatrics, School of Medicine
    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.