Current Environment:


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


Neonatal Seizure, Epilepsy, Seizures, Inflammatory Response

Recruitment Status

Active, not recruiting

Detailed Description

Seizures are a common symptom of neurologic dysfunction in the neonatal period, affecting more than 16,000 newborns in the United States per year. Over 25% of neonates with acute symptomatic seizures develop post- neonatal epilepsy (PNE), which is often resistant to medical therapies. There is a critical need to identify those patients most at risk for PNE and understand the mechanisms by which early seizures increase the propensity for recurrent seizures, in hopes of identifying novel therapeutic targets in this population. There is increasing evidence for the role of neuro-inflammation in the development of epilepsy. Levels of cytokines and micro-RNA (miRNA) may serve as markers of disease severity and have been implicated in epileptogenesis in animal models. The purpose of this study is to evaluate plasma cytokine and miRNA levels after neonatal-onset acute symptomatic seizures and determine their association with acute seizure severity and PNE.

Eligibility Criteria

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.


Intervention Type

Intervention Name

Diagnostic Test

Blood draw





Min Age

1 Day

Max Age

4 Days

Download Date

August 14, 2023

Principal Investigator


Primary Contact Information

For more information on this trial, visit


For more information and to contact the study team:

Evaluating the Role of Inflammation in Neonatal Epileptogenesis NCT04259125