Safety of Sildenafil in Premature Infants

Last updated: March 9, 2026
Sponsor: University of North Carolina, Chapel Hill
Overall Status: Completed

Phase

2

Condition

Lung Disease

Treatment

Sildenafil

Placebo

Clinical Study ID

NCT03142568
17-2436
HHSN27500039
R01FD006099-01
75N94022F00001
  • Ages 7-28
  • All Genders

Study Summary

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 Office of Orphan Products Development (OOPD).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Receiving positive airway pressure (nasal continuous airway pressure, nasalintermittent positive pressure ventilation, or nasal cannula flow > 1LPM) ormechanical ventilation (high frequency or conventional)

  • <29 weeks gestational age at birth

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

Exclusion

Exclusion Criteria:

  • Currently receiving vasopressors

  • Currently receiving inhaled nitric oxide

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

  • Known allergy to sildenafil

  • Known sickle cell disease

  • Aspartate Aminotransferase (AST) > 225 U/L < 72 hours prior to randomization

  • Alanine Aminotransferase (ALT) > 150 U/L < 72 hours prior to randomization

Study Design

Total Participants: 109
Treatment Group(s): 2
Primary Treatment: Sildenafil
Phase: 2
Study Start date:
April 02, 2018
Estimated Completion Date:
March 01, 2025

Study Description

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.

Connect with a study center

  • Health Sciences Centre Hospital

    Winnipeg, Manitoba R3A 1R9
    Canada

    Site Not Available

  • University of Arkansas for Medical Sciences

    Little Rock, Arkansas 72205
    United States

    Site Not Available

  • University of Florida College of Medicine Jacksonville-Wolfson Children's Hospital

    Jacksonville, Florida 32209
    United States

    Site Not Available

  • University of Florida Jacksonville Shands Medical Center

    Jacksonville, Florida 32209
    United States

    Site Not Available

  • University of Illinois at Chicago

    Chicago, Illinois 60612
    United States

    Site Not Available

  • Riley Hospital for Children at IU Health

    Indianapolis, Indiana 46202
    United States

    Site Not Available

  • Wesley Medical Center

    Wichita, Kansas 67214
    United States

    Site Not Available

  • University of Kentucky

    Lexington, Kentucky 40356
    United States

    Site Not Available

  • Ochsner Baptist Medical Center

    New Orleans, Louisiana 70115
    United States

    Site Not Available

  • University of Mississippi Medical Center

    Jackson, Mississippi 39216
    United States

    Site Not Available

  • Children's Mercy Hospital

    Kansas City, Missouri 64108
    United States

    Site Not Available

  • Children's Hospital of Nevada at UMC

    Las Vegas, Nevada 89106
    United States

    Site Not Available

  • Hackensack University Medical Center

    Hackensack, New Jersey 07601
    United States

    Site Not Available

  • Monmouth Medical Center

    Long Branch, New Jersey 07740
    United States

    Site Not Available

  • Kings County Hospital Center

    Brooklyn, New York 11203
    United States

    Site Not Available

  • Cohen Children's Medical Center of NY

    New Hyde Park, New York 11040
    United States

    Site Not Available

  • Golisano Children's Hospital - University of Rochester Medical Center

    Rochester, New York 14642
    United States

    Site Not Available

  • WakeMed Health and Hospitals

    Raleigh, North Carolina 27610
    United States

    Site Not Available

  • New Hanover Regional Medical Center

    Wilmington, North Carolina 28402
    United States

    Site Not Available

  • Cincinnati Childrens Hospital Medical Center

    Cincinnati, Ohio 45229
    United States

    Site Not Available

  • University of Oklahoma

    Oklahoma City, Oklahoma 73104
    United States

    Site Not Available

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