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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.

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.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON24610
Enrollment
120
Registered
2005-09-09
Start date
2003-07-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

neonatal seizures in fullterm infants following perinatal asphyxia

Interventions

Following initiation of aEEG registration and the occurrence of the first subclinical seizure, and following parental consent, the infant will be randomised to group A (treatment of clinical as well s
Intermittent standard EEG can be performed and in case the EEG shows a status epilepticus this can be treated, but in case a subclinical seizure is seen on the standard EEG, this will not be treated w

Sponsors

None listed

Eligibility

Inclusion criteria

Inclusion criteria: Fullterm 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

Exclusion criteria: Preterm infants (<37 wks GA) and fullterm infants with neonatal seizures admitted after the first 24 hours after birth. Infants with chromosomal disorders, congenital anomalies and meningitis.

Design outcomes

Primary

MeasureTime frame
1. What is the number of electrographic seizure discharges missed if you do not monitor continuously; 2. Does instantaneous treatment of electrographical seizures lead to: a. A reduction of seizure discharges; b. Less damage on the neonatal MRI.

Secondary

MeasureTime frame
Does treatment of neonatal seizures lead to a reduced risk of postneonatal epilepsy (PNE) and d) an improved neurodevelopmental outcome at 24 months.

Contacts

Public ContactL.S. Vries, de

University Medical Center Utrecht (UMCU), P.O. Box 85090

l.devries@wkz.azu.nl

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)