Evaluating the Role of Inflammation in Neonatal Epileptogenesis

Completed

Conditions studied: Neonatal Seizure, Epilepsy, Seizures, Inflammatory Response

In brief

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

Key facts

Study ID

NCT04259125

Run by

University of California, San Francisco

People needed

72

Starts

2018-12-15

Expected to finish

2025-12-01

Last updated by the study team

2026-01-26

Who can join

Age: 0 and older, up to 0. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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.

Where it is running

• UCSF Benioff Children's Hospital Oakland — Oakland, California, United States
• University of California, San Francisco — San Francisco, California, United States
• Boston Children's Hospital — Boston, Massachusetts, United States
• University of Michigan, Mott Children's Hospital — Ann Arbor, Michigan, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.