The effect of treatment of neonatal electrographic seizures, detected with the continuous cerebral function monitoring, with respect to occurrence of postneonatal epilepsy and neurodevelopmental outcome.
Completed
- Conditions
- eonatal seizuresPregnancy and ChildbirthNeonatal seizures
- Registration Number
- ISRCTN61541169
- Lead Sponsor
- niversity Medical Centre Utrecht (UMCU) (Netherlands)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 120
Inclusion Criteria
Full term infants admitted to the neonatal intensive care unit, within the first 24 hours after birth with subclinical seizures on the aEEG, in 8 Dutch and 3 Belgium centres.
Exclusion Criteria
1. Preterm infants (less than 37 weeks Gestational Age [GA]) and full term infants with neonatal seizures admitted after the first 24 hours after birth
2. Infants with chromosomal disorders, congenital anomalies and meningitis
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. What is the number of electrographic seizure discharges missed if you do not monitor continuously<br>2. Does instantaneous treatment of electrographical seizures lead to:<br>2.1. A reduction of seizure discharges <br>2.2. Less damage on the neonatal Magnetic Resonance Imaging (MRI)
- Secondary Outcome Measures
Name Time Method Does treatment of neonatal seizures lead to a reduced risk of Post-Neonatal Epilepsy (PNE) and an improved neurodevelopmental outcome at 24 months.