Evaluating the Role of Inflammation in Neonatal Epileptogenesis (NCT04259125) | Clinical Trial Compass
CompletedNot Applicable
Evaluating the Role of Inflammation in Neonatal Epileptogenesis
United States72 participantsStarted 2018-12-15
Plain-language summary
The purpose of this study evaluate the relationship between inflammation and epilepsy in neonates with seizures after birth.
Who can participate
Age range1 Day – 4 Days
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
What they're measuring
1
Seizure burden
Timeframe: At study entry
2
Percentage of participants diagnosed with epilepsy