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New trial aims to find best seizure treatment for Oxygen-Deprived newborns

NCT ID NCT07284498

Symptom relief Sponsor: Mansoura University 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study will compare two medicines, phenobarbital and levetiracetam, to see which is safer and more effective at stopping seizures in newborns with moderate to severe brain injury from lack of oxygen (HIE). The trial plans to enroll 66 infants and will measure how many become seizure-free within 20-40 minutes of treatment. The goal is to improve care for these fragile newborns.

What this could mean

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

Active substance
Phenobarbital and Levetiracetam
What this could lead to
If successful, this could show which drug works better and safer for stopping seizures in newborns with HIE, potentially improving outcomes.
What could go wrong
This is a small, early-phase trial with only 66 participants, so results may not apply broadly. Both drugs have known side effects, and the study hasn't started yet.

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 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 66 people

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

Expected to start

Jan 2026

An estimate. Start dates often move.

Expected to finish

Oct 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

1 day to 30 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: 1. Neonates diagnosed with moderate or severe HIE. 2. Presence of clinical seizures (focal / generalized tonic /colonic, myoclonic, subtle and spasms) and/or documented amplitude electroencephalogram (aEEG) abnormality within the first 72 hours. Exclusion Criteria: 1. Exclusive metabolic causes. 2. Serum creatinine greater than 1.6 mg/dl. 3. Known pyridoxine-dependent seizures. 4. Prior treatment with anti-epileptic drugs.

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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.

Hie - hypoxic - ischemic encephalopathy Neonatal seizures

How to take part

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

  1. The places running it

    2 sites. 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

  • Al Galaa Teaching Hospital

    Cairo, Egypt

  • University Children's Hospital, Mansoura University

    Al Mansurah, Egypt

More trials for these conditions

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