Evaluating the Role of Inflammation in Neonatal Epileptogenesis

  • STATUS
    Recruiting
  • participants needed
    87
  • sponsor
    University of California, San Francisco
Updated on 19 February 2024
inflammatory response
epilepsy
encephalopathy
seizure
acute brain injury
eeg monitoring

Summary

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

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.

Details
Condition Seizure, Epilepsy, Epilepsy, Inflammatory Response, Neonatal Seizure
Age 1 years and younger
Treatment Blood Draw, Survey
Clinical Study IdentifierNCT04259125
SponsorUniversity of California, San Francisco
Last Modified on19 February 2024

Eligibility

Yes No Not Sure

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

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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.