Pharmacokinetics of Sildenafil in Premature Infants

Pharmacokinetics of Sildenafil in Premature Infants

The purpose of this study is to learn more about the safety and dosing of sildenafil in infants.

Pharmacokinetics and safety of sildenafil will be studied in preterm infants who are receiving sildenafil per standard of care or 1 dose prescribed for the study.

Inclusion Criteria:

Cohort 1:

• Gestational age 28 weeks or less receiving sildenafil as standard of care < 365 postnatal days

Cohort 2:

• Gestational age 28 weeks or less
• 7-28 postnatal days of age
• Mechanical ventilation or nasal continuous positive airway pressure (NCPAP) or high-flow nasal cannula
• Intravenous line in place

Exclusion Criteria:

Cohort 1:

• Any condition that would make the participant, in the opinion of the investigator, unsuitable for the study

Cohort 2:

• Previous exposure to sildenafil within 7 days prior to enrollment
• Any condition that would make the participant, in the opinion of the investigator, unsuitable for the study
• History of allergic reactions to sildenafil
• AST > ULN or ALT > 3x ULN
• Currently on a vasopressor for hypotension
• Known sickle cell disease