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Could inflammation after newborn seizures predict epilepsy?

NCT ID NCT04259125

Knowledge-focused Sponsor: University of California, San Francisco 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This completed study looked at 72 newborns who had seizures shortly after birth. Researchers measured inflammation markers in their blood and tracked whether they later developed epilepsy. The goal was to understand if inflammation plays a role in epilepsy risk after neonatal seizures.

What this could mean

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

What this could lead to
If successful, this research could help identify which newborns are at higher risk for epilepsy after seizures, leading to earlier monitoring or intervention.
What could go wrong
This is an observational study, not a treatment trial. It cannot prove cause and effect, and the small size (72 participants) limits how broadly the findings can be applied.

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.

Participants

72 people

The number who actually took part.

Started

Dec 2018

Finished

Dec 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.

Who is studied

Newborns who are admitted at one of the participating children's hospitals

Ages

1 day to 4 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.

For participants in the acute symptomatic seizure group: Inclusion Criteria: * Neonates \<44 weeks corrected age at seizure onset * Seizures due to acute brain injury * Parent(s) who are English or Spanish literate (with assistance of interpreter) Exclusion Criteria: * Neonates at risk for adverse outcome independent of seizures and underlying brain injury * Neonates with mild, temporary causes for seizures * Newborns with neonatal-onset epilepsy syndromes * Neonates who do not survive the initial hospital admission * Neonates will not be excluded based on race, ethnicity, gender or gestational age For participants in the control group: Inclusion Criteria: * Neonates that are born \> 37 weeks and \<44 weeks postmenstrual age at enrollment * Consultation by the pediatric neurology inpatient service due neonatal paroxysmal events, with normal neurologic examination and ultimate diagnosis of non-epileptic spells on continuous video-EEG (ordered for clinical purposes, not for research) OR consultation for hypoxic ischemic encephalopathy in neonates undergoing therapeutic hypothermia, with early exit from therapy owing to normal neurologic examination, normal continuous video-EEG and uncertain diagnosis of encephalopathy. * Neonates requiring neurologic consultation for mild hypoxic-ischemic encephalopathy (HIE) undergoing therapeutic hypothermia, with normal examination, cEEG, and neuroimaging upon rewarming.

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Conditions

The condition(s) this trial relates to.

epilepsy Inflammation inflammatory disease visual epilepsy

As listed by the trial registrant

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

Epilepsy Inflammatory response Neonatal seizure Seizures

Contacts and locations

Locations

  • Boston Children's Hospital

    Boston, Massachusetts, 02115, United States

  • UCSF Benioff Children's Hospital Oakland

    Oakland, California, 94609, United States

  • University of California, San Francisco

    San Francisco, California, 94158, United States

  • University of Michigan, Mott Children's Hospital

    Ann Arbor, Michigan, 48103, United States

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