Summary

Location
at Oakland, California and other locations
Dates
study started
estimated completion
Principal Investigator
Adam L Numis, MD
Photo of Adam L Numis
Adam L Numis

Description

Summary

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

Official Title

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

Details

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.

Keywords

Neonatal Seizure Epilepsy Seizures Inflammatory Response Inflammation Cytokine Micro-RNA EEG Blood draw Acute symptomatic seizures

Eligibility

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 gestational age
  • Neonates referred for video-EEG monitoring for spells, with normal EEG AND normal neuroimaging (head ultrasound or MRI)
  • Neonates considered for cooling but felt not to meet formal criteria for hypoxic ischemic encephalopathy

Locations

  • UCSF Benioff Children's Hospital Oakland accepting new patients
    Oakland California 94609 United States
  • University of California, San Francisco accepting new patients
    San Francisco California 94158 United States

Lead Scientist at UCSF

  • Adam L Numis, MD
    Assistant Professor, Neurology. Authored (or co-authored) 23 research publications. Research interests: pediatric epilepsy · epileptogenesis · infantile spasms · neonatal seizures · inflammation · cytokines · micro-RNA.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT04259125
Study Type
Observational
Last Updated