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Can a common drug protect Babies' brains after a difficult birth?

NCT ID NCT05275725

Disease control 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 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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

Birth asphyxia, when a baby does not get enough oxygen around birth, can lead to brain injury and long-term disability. This Phase 1 trial in Uganda tests sildenafil, a drug that widens blood vessels, in 18 newborns with birth asphyxia. Researchers want to find the highest dose that babies can tolerate safely and watch for side effects. The goal is to see if sildenafil could one day be an affordable treatment to support early brain development in low-income countries.

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 that widens blood vessels and may protect the brain after oxygen loss at birth
What this could lead to
If sildenafil proves safe and tolerable, it could become an affordable, easy-to-give treatment that helps newborns in low-income countries survive birth asphyxia with better brain development.
What could go wrong
This is a very small, early-stage trial with only 18 babies, so it cannot show whether sildenafil actually improves outcomes. The drug can lower blood pressure and cause other serious side effects in fragile newborns, and the results may not apply to other settings.

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

18 people

The number who actually took part.

Started

Jul 2022

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

0 days to 18 months

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 birth asphyxia * Gestational age ≥ 36 weeks and birth weight ≥ 1800 g; * Admitted to Kawempe Hospital or Nsambya Hospital within 48 hours of life; * Need for continued resuscitation after birth and/or 5-minute Apgar score ≤5; * Evidence of neonatal encephalopathy by an abnormal neurological exam (modified Sarnat score of 2-3 or abnormal aEEG). Exclusion Criteria: * Absent heart rate at 10 minutes/imminent death * Neonates with major congenital malformations * Neonates with grade 3 AKI (serum creatinine rise ≥3x lowest previous creatinine or creatinine \> 2.5 mg/dL = 221 mcmol/L or receipt of dialysis) * Neonates with intraventricular and/or intraparenchymal hemorrhage on cranial ultrasound (cUS) performed on day 1-2 of life * Mother living permanently outside 20km radius of Kawempe Hospital or Nsambya Hospital * Neonates whose parents are unwilling or unable to give informed written consent to enter the study

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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

  • Kawempe National Referral Hospital

    Kawempe, Uganda

More trials for these conditions

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