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

SUBMITTER: Jackson W 

PROVIDER: S-EPMC8569839 | biostudies-literature | 2022 Jan

REPOSITORIES: biostudies-literature