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Can a simple supplement heal newborn brains after birth injury?

NCT ID NCT07763145

Disease control Sponsor: Khyber Girls Medical College 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 13, 2026 · Last updated Aug 25, 2026 · Updated 3 times

Summary

This trial tests whether citicoline, a compound that may support brain cell repair, can improve outcomes in newborns with hypoxic-ischemic encephalopathy (HIE) — brain injury from oxygen deprivation at birth. About 86 infants with signs of birth asphyxia will receive either citicoline plus standard care or standard care alone. After 72 hours, researchers will compare brain blood flow and neurological severity scores to see if citicoline aids recovery.

What this could mean

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

Active substance
citicoline
What this could lead to
If effective, citicoline could offer a simple, accessible treatment to improve brain recovery in newborns with oxygen deprivation at birth.
What could go wrong
This is a small, early-stage trial, and results may not generalize. The drug's benefits are unproven, and potential side effects in newborns are not fully known.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 86 people

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

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Dec 2026

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 to 24 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: * All inborn neonates diagnosed with APGAR score (Table 2) less then 8/10 at 5 min of life presenting to the emergency room within the first day of life. * Outborn babies admitted in the last 24 hours with history or clinical features of perinatal asphyxia. EXCLUSION CRITERIA : * Neonates who have received therapeutic hypothermia * Neonates with congenital, developmental or chromosomal malformations * Significant antenatal risk factors leading to early-onset sepsis\\DIC or CNS depression unrelated to asphyxia * Preterm neonates \<35 weeks * No consent could be obtained

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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.

Hypoxic ischaemic encephalopathy (HIE)

How to take part

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

  1. The places running it

    1 site. 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

  • Hayatabad Medical Complex

    Peshawar, KPK, 25000, Pakistan

More trials for these conditions

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