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NCT04259125Completed

Evaluating the Role of Inflammation in Neonatal Epileptogenesis

Neonatal Seizure Registry: The Role of Inflammation After Neonatal Seizures and Later Development of Epilepsy

Source: ClinicalTrials.gov · Last updated 26 Jan 2026

Brief summary (registry, in English)

The purpose of this study evaluate the relationship between inflammation and epilepsy in neonates with seizures after birth.

Status (registry)
Completed
Study type
Observational
Enrollment
72 (actual)
First submitted
4 Feb 2020
Start date
15 Dec 2018
Primary completion date
1 Nov 2024
Lead sponsor
University of California, San Francisco
Diseases
Epilepsy
NCT number
NCT04259125

What you commit to

  • Study type: Observational
  • Participants enrolled: 72
  • From 15 Dec 2018 to the primary completion date, 1 Nov 2024
  • 4 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • 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

Age

  • Neonates will not be excluded based on race, ethnicity, gender or gestational age
    • For participants in the control group:

Other

  • Neonates who do not survive the initial hospital admission

Who the study is looking for

  • 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)
  • 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.

Criteria the registry did not label

  • For participants in the acute symptomatic seizure group:

Age in the registry: 1 day to 4 days · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (4)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University of Michigan/Mott Children's Hospital
Coordinator of this site? Confirm its status
Ann ArborUnited StatesUnknown status
Boston Children's Hospital
Coordinator of this site? Confirm its status
BostonUnited StatesUnknown status
UCSF Benioff Children's Hospital Oakland
Coordinator of this site? Confirm its status
OaklandUnited StatesUnknown status
University of California San Francisco
Coordinator of this site? Confirm its status
San FranciscoUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.