Evaluating the Role of Inflammation in Neonatal Epileptogenesis

NCT04259125 | Completed

• 1 other identifier: K23NS105918
• Study Type: observational
• Target: 72
• Locations: 1 country
• Sites: 4

Brief Summary

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

Conditions

Epilepsy; Seizures; Inflammatory Response; Neonatal Seizure

Keywords

Neonatal seizure; Inflammation; Cytokine; Micro-RNA; Epilepsy; EEG

Outcome Measures

Primary Outcomes (2)

• Seizure burden

  Investigators will evaluate the seizure burden from the initial diagnostic electroencephalogram (EEG) after birth by determining the average number of seizures per hour.

  At study entry

• Percentage of participants diagnosed with epilepsy

  The investigators will determine the proportion of participants who develop clinical and or electrographic seizures.

  24 months of age

Secondary Outcomes (5)

• Percentage of participants diagnosed with epilepsy

  12 months of age

• Epilepsy Severity

  12 months of age

• Epilepsy Severity

  24 months of age

• Warner Initial Developmental Evaluation of Adaptive and Functional Skills (WIDEA-FS)

  Assessment takes up to 15 minutes and will be conducted at 12 months of age

• Warner Initial Developmental Evaluation of Adaptive and Functional Skills (WIDEA-FS)

  Assessment takes up to 15 minutes and will be conducted at 24 months of age

Study Arms (2)

Acute symptomatic seizures

This is a cohort of 72 participants who will be enrolled into this study from the neonatal intensive care unit (NICU) after being diagnosed with seizures. They will be asked to contribute a blood specimen obtained ideally 48-96 hours (though blood collection allowed 24-120 hours) after seizures are diagnosed, to participate in an optional blood draw at 2-4 months of age, and to complete surveys at 12 \& 24 months of age.

Diagnostic Test: Blood draw; Other: Survey

Control

This is a cohort of 15 participants who will be enrolled into this study from the neonatal intensive care unit (NICU) after having an EEG for possible seizures, but found to have a normal EEG. They will be asked to contribute a blood specimen obtained ideally 48-96 hours (though blood collection allowed 24-120 hours) after birth.

Diagnostic Test: Blood draw

Interventions

Survey OTHER

Regarding epilepsy and development.

Acute symptomatic seizures

Blood draw DIAGNOSTIC_TEST

Evaluation of plasma inflammatory markers including cytokines and micro-RNA.

Acute symptomatic seizures; Control

Eligibility Criteria

• Age: 1 Day - 4 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

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

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:
• 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.

Sponsors & Collaborators

• University of Michigan: collaborator
• Boston Children's Hospital: collaborator
• UCSF Benioff Children's Hospital Oakland: collaborator
• University of California, San Francisco: lead
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator

Study Sites (4)

UCSF Benioff Children's Hospital Oakland

Oakland, California, 94609, United States

Location

University of California, San Francisco

San Francisco, California, 94158, United States

Location

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location

University of Michigan, Mott Children's Hospital

Ann Arbor, Michigan, 48103, United States

Location

Related Publications (1)

• Numis AL, Foster-Barber A, Deng X, Rogers EE, Barkovich AJ, Ferriero DM, Glass HC. Early changes in pro-inflammatory cytokine levels in neonates with encephalopathy are associated with remote epilepsy. Pediatr Res. 2019 Nov;86(5):616-621. doi: 10.1038/s41390-019-0473-x. Epub 2019 Jun 24.

  PMID: 31234194 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma.

MeSH Terms

Conditions

Epilepsy; Seizures; Inflammation

Interventions

Blood Specimen Collection; Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques; Data Collection; Epidemiologic Methods; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Adam L Numis, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2020
• First Posted: February 6, 2020
• Study Start: December 15, 2018
• Primary Completion: November 1, 2024
• Study Completion: December 1, 2025
• Last Updated: January 26, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)