NCT04259125

Evaluating the Role of Inflammation in Neonatal Epileptogenesis

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 72 (actual)
• Sponsor: University of California, San Francisco · Academic / Other
• Sex: All
• Age: 1 Day – 4 Days
• Healthy volunteers: Not accepted

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.

Conditions

• Neonatal Seizure
• Epilepsy
• Seizures
• Inflammatory Response

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Blood draw	Evaluation of plasma inflammatory markers including cytokines and micro-RNA.
OTHER	Survey	Regarding epilepsy and development.

Timeline

• Start date: 2018-12-15
• Primary completion: 2024-11-01
• Completion: 2025-12-01
• First posted: 2020-02-06
• Last updated: 2026-01-26

Locations

4 sites across 1 country: United States