Pharmacokinetics of Sildenafil in Premature Infants

University of North Carolina (UNC)

Status and phase

Completed

Phase 1

Conditions

Persistent Pulmonary Hypertension of the Newborn

Treatments

Drug: 1 dose of sildenafil

Study type

Interventional

Funder types

Other

Industry

NIH

Identifiers

NCT01670136

11-1646

HHSN27500014 (Other Grant/Funding Number)

Details and patient eligibility

About

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

Full description

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.

Enrollment

34 patients

Sex

All

Ages

Under 364 days old

Volunteers

No Healthy Volunteers

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