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Can a common heart drug help fragile preemies? new study tests safety

NCT ID NCT04447989

Disease control Sponsor: Christoph Hornik Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at whether the drug sildenafil is safe for premature infants with a severe lung condition called bronchopulmonary dysplasia (BPD). The study included 125 babies in hospital intensive care units. Researchers monitored for dangerously low blood pressure as the main safety measure.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

125 people

The number who actually took part.

Started

May 2021

Finished

Jan 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

Up to 29 weeks

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Documented informed consent from parent or guardian, prior to study procedures 2. \< 29 weeks gestational age at birth 3. 32-44 weeks postmenstrual age 4. Receiving respiratory support at enrollment: * If 32 0/7-35 6/7 weeks postmenstrual age: mechanical ventilation (high frequency or conventional) * If 36 0/7-44 6/7 weeks postmenstrual age: mechanical ventilation (high frequency or conventional) OR continuous positive airway pressure (CPAP) Note: * Criteria 3 and 4 define severe BPD for the purposes of this study * CPAP is defined as any of the following: * Nasal cannula \> 2 liters per minute (LPM) * Nasal continuous positive airway pressure (NCPAP) * Nasal intermittent positive pressure ventilation (NIPPV) * Noninvasive neurally adjusted ventilatory assist (NAVA) * Any other device designed to provide positive pressure through a nasal device (e.g., RAM cannula, etc.) Exclusion Criteria: 1. Previous enrollment and dosing in this study, protocol number (NHLBI-2019-SIL), "Safety of Sildenafil in Premature Infants with Severe Bronchopulmonary Dysplasia (BPD)" 2. Previous exposure to sildenafil within 7 days prior to randomization\* 3. Previous exposure to vasopressors within 24 hours prior to randomization\* 4. Previous exposure to inhaled nitric oxide within 24 hours prior to randomization\* 5. Previous exposure to milrinone within 24 hours prior to randomization\* 6. Evidence of pulmonary hypertension or moderate/large patent ductus arteriosus (PDA) on the most recent echocardiogram performed within 14 days prior to randomization 7. Known major congenital heart defect requiring medical or surgical intervention in the neonatal period 8. Known allergy to sildenafil 9. Known sickle cell disease 10. Aspartate aminotransferase (AST) \> 225 U/L \< 72 hours prior to randomization 11. Alanine aminotransferase (ALT) \> 150 U/L \< 72 hours prior to randomization 12. Any condition that would make the participant, in the opinion of the investigator, unsuitable for the study. * Participant will be reassessed prior to dosing to reconfirm eligibility criteria.

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Conditions

The condition(s) this trial relates to.

bronchopulmonary dysplasia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Bronchopulmonary dysplasia of newborn

Contacts and locations

Locations

  • Arkansas Children's Research Institute

    Little Rock, Arkansas, 72202, United States

  • Boston Children's Hospital

    Boston, Massachusetts, 02115, United States

  • Children's Hospital of Nevada at University Medical Center

    Las Vegas, Nevada, 89102, United States

  • Childrens Mercy Hospital

    Kansas City, Missouri, 64108, United States

  • Childrens National Medical Center

    Washington D.C., District of Columbia, 20010, United States

  • East Carolina University

    Greenville, North Carolina, 27858, United States

  • Emory Children's Center

    Atlanta, Georgia, 30322, United States

  • Lurie Children's Hospital

    Chicago, Illinois, 60611-2605, United States

  • Ochsner Baptist Medical Center

    New Orleans, Louisiana, 70115, United States

  • Rady Children's Hospital and Health Center

    San Diego, California, 92123, United States

  • Rainbow Babies and Childrens Hospital

    Cleveland, Ohio, 44106, United States

  • University of Arkansas Medical Sciences

    Little Rock, Arkansas, 72205, United States

  • University of Florida Jacksonville Shands Medical Center

    Jacksonville, Florida, 32209, United States

  • University of Illinois at Chicago

    Chicago, Illinois, 60611, United States

  • University of Kentucky Chandler Medical Center

    Lexington, Kentucky, 40506, United States

  • University of Louisville School of Medicine

    Louisville, Kentucky, 40202, United States

  • University of Mississippi Medical Center

    Jackson, Mississippi, 39216, United States

  • University of NC at Chapel Hill

    Chapel Hill, North Carolina, 27599, United States

  • University of Rochester School of Medicine Children's Hospital

    Rochester, New York, 14642, United States

  • University of Tennessee Health Science Center

    Memphis, Tennessee, 38163, United States

  • University of Texas Health

    Austin, Texas, 78723, United States

  • Wake Forest University Health Sciences

    Winston-Salem, North Carolina, 27157, United States

  • Westchester Medical Center - New York Medical College

    Valhalla, New York, 10595, United States

  • Wolfson Children's Hospital

    Jacksonville, Florida, 32209, United States

  • Women's Hospital of Texas

    Houston, Texas, 77054, United States