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

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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
9
sites
Brooklyn, New York 11203
Principal Investigator: Gratias T Mundakel, MD
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1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
Principal Investigator: Ambalavanan Namasivayam, MD
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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3333 Burnet Avenue # Mlc3008
Cincinnati, Ohio 45229
 1-513-636-4200 
Principal Investigator: Brenda Poindexter, MD
Cincinnati Children's Hospital Medical Center Patients and families from across the region and around the...
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Durham, North Carolina 27710
(919) 684-8111
Principal Investigator: C. Michael Cotten, MD
Duke University Younger than most other prestigious U.S. research universities, Duke University consistently ranks among...
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Albany, New York 12208
Principal Investigator: Marilyn Fisher, MD
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Chapel Hill, North Carolina 27599
(919) 962-2211
Principal Investigator: Sigal Peter-Wohl, MD
Univ of North Carolina Carolina’s vibrant people and programs attest to the University’s long-standing place...
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Chapel Hill, NC
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171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
Principal Investigator: Andrew Atz, MD
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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Indianapolis, Indiana
Principal Investigator: Gregory Sokol, MD
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Indianapolis, IN
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Louisville, Kentucky 40202
Principal Investigator: Dan Stewart, MD
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