Pharmacokinetics of Sildenafil in Premature Infants

Status:	Recruiting
Conditions:	High Blood Pressure (Hypertension)
Therapuetic Areas:	Cardiology / Vascular Diseases
Healthy:	No
Age Range:	Any
Updated:	7/16/2016
Start Date:	February 2013
End Date:	August 2016
Contact:	Matthew M Laughon, MD, MPH
Email:	matt_laughon@med.unc.edu
Phone:	984-974-5063

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

We found this trial at

sites

Albany Medical Center

Albany, New York 12208

Principal Investigator: Marilyn Fisher, MD

from

Albany, NY