ANSeR- The Algorithm for Neonatal Seizure Recognition Study

University College Cork (UCC)

Status: Completed

Conditions: Neonatal Seizures

Treatments: Device: Algorithm for Neonatal Seizure Recognition

Study type: Observational

Funder types: Other

Identifiers

NCT02160171

GB0113UCC

Details and patient eligibility

About

A Multicentre Clinical Evaluation of a Decision Support Algorithm for Neonatal Seizure Detection: ANSeR

Full description

This is a multi-centre study. It will be based on routine clinical practice but will also allow for the off-line retrospective application of ANSeR to a well-defined clinical population in order to establish the potential diagnostic utility of the algorithm.

Enrollment: 240 patients

Sex: All

Ages: 36+ weeks old

Volunteers: No Healthy Volunteers

Inclusion criteria

All term neonates at risk of seizures are eligible for the ANSeR study.

Neonates ≥ 36 weeks gestation will be recruited if:

They have a need for EEG monitoring.

Exclusion criteria

Consent of parents not obtained.

Trial design

240 participants in 1 patient group

Term neonates

Description:

Term neonates who are undergoing continuous video amplified Electroencephalogram (aEEG)/Electroencephalogram (EEG) monitoring for clinical purposes (e.g. because seizures were suspected, or the neonate is being treated with therapeutic hypothermia). EEGs will be analysed off line by 'Algorithm for Neonatal Seizure Recognition'

Treatment:

Device: Algorithm for Neonatal Seizure Recognition