Safety of Sildenafil in Premature Infants



Status:Recruiting
Conditions:Bronchitis
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:Any
Updated:1/17/2019
Start Date:April 2, 2018
End Date:August 2019
Contact:Matthew M Laughon, MD, MPH
Email:matt_laughon@med.unc.edu
Phone:984-974-7851

Use our guide to learn which trials are right for you!

Safety of Sildenafil in Premature Infants at Risk of Bronchopulmonary Dysplasia

Describe the safety of sildenafil in premature infants at risk of bronchopulmonary dysplasia
and determine preliminary effectiveness and pharmacokinetics (PK) of sildenafil. Funding
Source - FDA OOPD.

This will be a multi-center, randomized, placebo-controlled, sequential dose escalating,
double masked, safety data study of sildenafil in premature infants.

This is a Phase II study design, premature infants (inpatient in neonatal intensive care
units) will be randomized in a dose escalating approach 3:1 (sildenafil: placebo) into 3
cohorts with escalating doses of sildenafil. There will be 40 randomized and dosed
participants in each cohort for a total of up to 120 participants. Cohort 1 sildenafil dose
will be 0.125 mg/kg q 8 hours IV or 0.25 mg/kg q 8 hours enteral. Cohort 2 sildenafil dose
will be 0.5 mg/kg q 8 hours IV or 1.0 mg/kg q 8 hours enteral. Cohort 3 sildenafil dose will
be 1 mg/kg q 8 hours IV or 2 mg/kg q 8 hours enteral.

Inclusion Criteria:

- Receiving positive airway pressure (nasal continuous airway pressure, nasal
intermittent positive pressure ventilation, or nasal cannula flow > 1LPM) or
mechanical ventilation (high frequency or conventional)

- <29 weeks gestational age at birth

- 7-28 (inclusive) days postnatal age at time of randomization

Exclusion Criteria:

- Currently receiving vasopressors

- Currently receiving inhaled nitric oxide

- Baseline mean arterial pressure < gestational age (in weeks) plus postnatal age (in
weeks) within 2 hours of sildenafil administration

- Known allergy to sildenafil

- Known sickle cell disease

- AST > 225 U/L < 72 hours prior to randomization

- ALT > 150 U/L < 72 hours prior to randomization
We found this trial at
11
sites
Brooklyn, New York 11203
Principal Investigator: Gratias Mundakel, MD
?
mi
from
Brooklyn, NY
Click here to add this to my saved trials
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...
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
529 West Markham Street
Little Rock, Arkansas 72205
(501) 686-7000
Principal Investigator: Sherry Courtney, MD
University of Arkansas for Medical Sciences The University of Arkansas for Medical Sciences (UAMS) in...
?
mi
from
Little Rock, AR
Click here to add this to my saved trials
Indianapolis, Indiana 46202
Principal Investigator: Gregory Sokol, MD
?
mi
from
Indianapolis, IN
Click here to add this to my saved trials
800 Hope Place
Las Vegas, Nevada 89106
Principal Investigator: Alaa Eldemerdash, MD
Phone: 702-207-8345
?
mi
from
Las Vegas, NV
Click here to add this to my saved trials
New Hyde Park, New York 11040
Principal Investigator: Mohamed N Ahmed, MD
?
mi
from
New Hyde Park, NY
Click here to add this to my saved trials
New Orleans, Louisiana 70115
Principal Investigator: Amanda England, MD
?
mi
from
New Orleans, LA
Click here to add this to my saved trials
1100 N. Lindsay
Oklahoma City, Oklahoma 73104
(405) 271-4000
Principal Investigator: Kimberly Ernst, MD
University of Oklahoma The OU Health Sciences Center is composed of seven health-related colleges located...
?
mi
from
Oklahoma City, OK
Click here to add this to my saved trials
Raleigh, North Carolina 27610
Principal Investigator: Stephen Kicklighter, MD
?
mi
from
Raleigh, NC
Click here to add this to my saved trials
601 Elmwood Avenue
Rochester, New York 14642
Principal Investigator: Gloria Pryhuber, MD
?
mi
from
Rochester, NY
Click here to add this to my saved trials
550 N Hillside St
Wichita, Kansas 67214
(316) 962-2000
Principal Investigator: Barry Bloom, MD
Wesley Medical Center Welcome to one of the most experienced and comprehensive medical centers in...
?
mi
from
Wichita, KS
Click here to add this to my saved trials