Epilepsy, Inflammatory Response, Neonatal Seizure, Seizures
Conditions
Keywords
Neonatal seizure, Inflammation, Cytokine, Micro-RNA, Epilepsy, EEG
Brief summary
The purpose of this study evaluate the relationship between inflammation and epilepsy in neonates with seizures after birth.
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.
Interventions
DIAGNOSTIC_TESTBlood draw
Evaluation of plasma inflammatory markers including cytokines and micro-RNA.
OTHERSurvey
Regarding epilepsy and development.
Sponsors
University of California, San Francisco
University of Michigan
Boston Children's Hospital
UCSF Benioff Children's Hospital Oakland
National Institute of Neurological Disorders and Stroke (NINDS)
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
1 Days to 4 Days
Healthy volunteers
No
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Seizure burden | At study entry | Investigators will evaluate the seizure burden from the initial diagnostic electroencephalogram (EEG) after birth by determining the average number of seizures per hour. |
| Percentage of participants diagnosed with epilepsy | 24 months of age | The investigators will determine the proportion of participants who develop clinical and or electrographic seizures. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of participants diagnosed with epilepsy | 12 months of age | The investigators will determine the proportion of participants who develop clinical and or electrographic seizures. |
| Epilepsy Severity | 12 months of age | The investigators will administer an investigator-developed questionnaire designed to define the frequency of seizures (monthly, weekly, daily, or greater than daily). |
| 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 | The Warner Initial Developmental Evaluation of Adaptive and Functional Skills (WIDEA-FS) will be assessed at 12 months of age. The score ranges from 50 to 200 with higher scores associated with normal development. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORAdam L Numis, MD
University of California, San Francisco
Outcome results
None listed