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Could a common heart drug protect Preemies' lungs?

NCT ID NCT03142568

Disease control Sponsor: University of North Carolina, Chapel Hill 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested whether sildenafil, a drug used for high blood pressure in the lungs, is safe for premature infants at risk of bronchopulmonary dysplasia (BPD), a serious chronic lung disease. 109 babies born before 29 weeks and needing breathing support were given either sildenafil or a placebo. Researchers tracked side effects and measured how the drug moved through the body to see if it might help prevent lung damage.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
sildenafil (also known as Revatio)
What this could lead to
If sildenafil is found safe and effective, it could offer a new way to prevent or reduce lung damage in premature babies, potentially lowering the risk of bronchopulmonary dysplasia.
What could go wrong
This is an early Phase 2 safety study with only 109 infants, so results are preliminary. Sildenafil may not prove effective in larger trials, and side effects like retinopathy of prematurity remain a concern.

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

109 people

The number who actually took part.

Started

Apr 2018

Finished

Mar 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

7 to 28 days

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: * 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 * Aspartate Aminotransferase (AST) \> 225 U/L \< 72 hours prior to randomization * Alanine Aminotransferase (ALT) \> 150 U/L \< 72 hours prior to randomization

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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

Contacts and locations

Locations

  • Children's Hospital of Nevada at UMC

    Las Vegas, Nevada, 89106, United States

  • Cohen Children's Medical Center of NY

    New Hyde Park, New York, 11040, United States

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

    Rochester, New York, 14642, United States

  • Health Sciences Centre Hospital

    Winnipeg, Manitoba, R3A 1R9, Canada

  • Monmouth Medical Center

    Long Branch, New Jersey, 07740, United States

  • Ochsner Baptist Medical Center

    New Orleans, Louisiana, 70115, United States

  • University of Arkansas for Medical Sciences

    Little Rock, Arkansas, 72205, United States

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

    Jacksonville, Florida, 32209, United States

  • University of Florida Jacksonville Shands Medical Center

    Jacksonville, Florida, 32209, United States

  • University of Illinois at Chicago

    Chicago, Illinois, 60612, United States

  • University of Kentucky

    Lexington, Kentucky, 40356, United States

  • University of Mississippi Medical Center

    Jackson, Mississippi, 39216, United States

  • University of Oklahoma

    Oklahoma City, Oklahoma, 73104, United States

  • WakeMed Health and Hospitals

    Raleigh, North Carolina, 27610, United States

  • Wesley Medical Center

    Wichita, Kansas, 67214, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.