at Oakland, California and other locations
study started
completion around
Principal Investigator
by Adam L Numis, MD
Headshot of Adam L Numis
Adam L Numis



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


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.


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


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.


  • UCSF Benioff Children's Hospital Oakland
    Oakland California 94609 United States
  • UCSF
    San Francisco California 94158 United States
  • University of Michigan, Mott Children's Hospital
    Ann Arbor Michigan 48103 United States
  • Boston Children's Hospital
    Boston Massachusetts 02115 United States

Lead Scientist at UCSF

  • Adam L Numis, MD
    Dr. Adam L. Numis is a pediatric neurologist and specialist in epilepsy. He focuses on evaluating and caring for children with epilepsy, particularly those with difficult-to-treat seizures. His research includes evaluating the connection between inflammation and epilepsy.


in progress, not accepting new patients
Start Date
Completion Date
University of California, San Francisco
Study Type
Expecting 87 study participants
Last Updated