Pharmacokinetics of Sildenafil in Premature Infants

• Status: Completed
• Trial end date: 2016-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of North Carolina, Chapel Hill
• Collaborators: Duke University; Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); The Emmes Company, LLC; The EMMES Corporation
• Treatments: Sildenafil Citrate

Criteria

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