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Can a liquid Erectile-Dysfunction drug help repair Newborns' brains after oxygen starvation?

NCT ID NCT04169191

Symptom relief Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 15, 2026 · Last updated Sep 16, 2026 · Updated 1 time

Summary

When a baby is deprived of oxygen around birth, doctors cool the body to limit brain damage, but some infants still suffer lasting injury. This early-stage trial tests whether adding oral sildenafil, a drug that widens blood vessels, can further protect or repair the brain. Researchers will give increasing doses to a small group of newborns already receiving cooling therapy, watching for serious side effects like low blood pressure while measuring how the drug moves through the body. The goal is to find the highest dose that babies can tolerate safely.

What this could mean

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

Active substance
sildenafil, given as an oral liquid
What this could lead to
If it works, sildenafil could become a new add-on treatment to help newborns with brain injury from birth asphyxia, beyond the cooling therapy used today.
What could go wrong
This is a very early Phase 1 trial in only 20 babies, so its main goal is to find a safe dose, not to prove benefit. Sildenafil can lower blood pressure, which is a particular concern in sick newborns.

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 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

20 people

The number who actually took part.

Started

Sep 2019

Finished

Oct 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

0 to 2 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: * Male and female neonates meeting the criteria for induced hypothermia: * Gestational age ≥ 36 weeks and birth weight ≥ 1800 g; * Evidence of fetal distress, i.e., history of an acute perinatal event, cord pH ≤ 7.0 or base deficit ≤ - 16 mEq/L; * Evidence of neonatal distress, such as an Apgar score ≤ 5 at 10 minutes, postnatal blood gas pH obtained within the first hour of life ≤ 7.0 or base deficit ≤ - 16 mEq/L, or a continued need for ventilation initiated at birth and continued for at least 10 minutes; * Evidence of moderate to severe neonatal encephalopathy by an abnormal neurological exam and/or an amplitude-integrated electroencephalogram (aEEG). * Evidence of brain injury on a brain magnetic resonance imaging (MRI) performed on day 2 of life. Exclusion Criteria: * Neonates with complex congenital heart disease * Neonates with cerebral malformations * Neonates with genetic syndrome * Neonates with intraventricular and/or intraparenchymal hemorrhage on MRI performed on day 2 of life

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Conditions

The condition(s) this trial relates to.

perinatal asphyxia

As listed by the trial registrant

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

Birth asphyxia

Contacts and locations

Locations

  • Montreal Children's Hospital

    Montreal, Quebec, H4A3J1, Canada

More trials for these conditions

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