Pharmacokinetics of Sildenafil in Premature Infants

Completed · Phase 1

Conditions studied: Persistent Pulmonary Hypertension of the Newborn

In brief

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

Key facts

Study ID

NCT01670136

Run by

University of North Carolina, Chapel Hill

People needed

34

Starts

2013-02-01

Expected to finish

2016-07-01

Last updated by the study team

2016-11-02

Who can join

Age: any, up to 1. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• Riley Hospital — Indianapolis, Indiana, United States
• Kosair Pediatric Research Unit — Louisville, Kentucky, United States
• Albany Medical Center — Albany, New York, United States
• Kings County Hospital Center/SUNY Downstate Medical Center — Brooklyn, New York, United States
• University of North Carolina — Chapel Hill, North Carolina, United States
• Duke University — Durham, North Carolina, United States
• Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States
• Medical University of South Carolina — Charleston, South Carolina, United States

Full record on ClinicalTrials.gov

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