Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

Viagra-Like drug tested to repair Newborns' brain damage

NCT ID NCT06098833

Cure Sponsor: Pia Wintermark Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 18, 2026 · Updated 3 times

Summary

When babies lack oxygen around birth, they can suffer lasting brain damage. No treatment currently repairs that injury. Researchers are testing whether oral sildenafil, a drug already used safely in babies for lung blood pressure, can help. In this Phase 2 trial, 60 newborns with asphyxia receive sildenafil or a placebo for seven days, and doctors measure brain injury and safety.

What this could mean

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

Active substance
sildenafil, a drug also known as Viagra
What this could lead to
If it works, sildenafil could become the first treatment to repair brain damage in babies who lack oxygen at birth, possibly reducing cerebral palsy and learning problems.
What could go wrong
This is a small Phase 2 trial, so it may not show a clear benefit or could reveal side effects like low blood pressure. Results in 60 babies may not apply to all newborns with this condition.

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

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2024

Expected to finish

Oct 2031

An estimate. End dates often move.

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 minutes to 48 hours

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 ≥36weeks and birth weight ≥1800g; * 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). They will receive whole-body cooling to an esophageal temperature of 33.5°C, initiated within the first 6 hours of life, continued for 72 hours, and then they will be slowly rewarmed using standard protocol. * 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 * Moribund infants not expected to survive

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Neonatal encephalopathy are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

brain hypoxia - ischemia perinatal asphyxia

As listed by the trial registrant

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

Neonatal encephalopathy

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    3 sites in 2 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Centre Hospitalier Universitaire Sainte-Justine

    RECRUITING

    Montreal, Quebec, H3T 1C5, Canada

  • Children's Hospital Colorado

    RECRUITING

    Denver, Colorado, 80045, United States

  • Montreal Children's Hospital

    RECRUITING

    Montreal, Quebec, H3C 0T3, Canada

More trials for these conditions

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