The Impact of Electroencephalographic (EEG) Seizure Treatment in Neonatal Encephalopathy (NCT01027715) | Clinical Trial Compass
CompletedNot Applicable
The Impact of Electroencephalographic (EEG) Seizure Treatment in Neonatal Encephalopathy
United States69 participantsStarted 2010-01
Plain-language summary
This is a prospective, randomized, single-center pilot trial of term and near term (≥ 36 weeks gestation) infants with encephalopathy or seizures comparing a "EEG Seizure Treatment Group" or ESG with a "Clinical Seizure Treatment Group" or CSG.
The investigators hypothesize that the accurate detection and treatment of EEG seizures will decrease the seizure burden and improve outcomes in newborn infants with seizures and/or hypoxic-ischemic encephalopathy (HIE).
Who can participate
Age range
1 Hour – 72 Hours
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Term or near term infants ≥ 36 weeks gestation admitted to the neonatal intensive care unit
* ≤ 72 hours of age
* Screening for the "at risk" infant by the clinical team to include any one of the following:
* Apgar score \<5 at 5 min
* Cord blood or postnatal gas with pH \<7.0 or BE \> -12
* Need for respiratory support at 10 min of life
* Suspected or definite seizures
* Encephalopathy defined by recognition of altered neurological behavior
* Infants identified in the above screen will be examined by the research team and will be eligible if they satisfy at least one of the following:
* Moderate-severe neonatal encephalopathy (3 out of 6 criteria)
* Suspected or definite neonatal seizures
Exclusion criteria:
* Infants \< 36 weeks gestation
* \> 72 hours of age
* Infants with congenital anomalies of the central nervous system
* Moribund infants for whom no further aggressive treatment is planned
* Metabolic disorders or documented CNS infection
* Neuro-muscular blockade
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Seizure burden
Timeframe: 2 to 3 years
2
Presence of a single combined event: death in the first two years of life or moderate or severe disability at 18-24 months