The ANSeR Clinical Investigation
Research type
Research Study
Full title
A multi-centre, randomised, controlled, clinical Investigation of a standalone decision support Algorithm for Neonatal Seizure Recognition
IRAS ID
165037
Contact name
Janet Rennie
Contact email
Sponsor organisation
University College Cork
Duration of Study in the UK
1 years, 6 months, 30 days
Research summary
Seizures are the most common neurological emergency encountered in the neonatal intensive care unit (NICU) and are the hallmark of neonatal encephalopathy. Despite this they remain difficult to diagnose clinically. Electroencephalography (EEG) monitoring is the gold standard for seizure detection but real-time interpretation is challenging for most in the acute setting. All experts agree that there is an urgent need for an accurate and robust method of seizure detection, which can provide information in a readily digestible form, in real time at the cotside. Translating automated seizure detection from the bench to the cotside is challenging, and has not so far been achieved. The Neonatal Brain Research Group at University College Cork in collaboration with University College London Hospital have developed, trained and tested a novel EEG based seizure detection Software System for term neonates in the NICU. We are now satisfied with the performance of this system off-line in term neonates and wish to embark on a real-time multicentre clinical investigation. This will be an open, two arm, parallel group, randomised, controlled investigation of the ANSeR Software System as a stand-alone neonatal seizure recognition decision support tool. Term neonates requiring EEG monitoring will be stratified by recruiting site and then randomised to receive standard clinical care including EEG monitoring either with the ANSeR Software System or without the ANSeR Software System. Treatment of any seizures identified by the treating clinician will be as per local procedures and guidelines for both arms of the investigation.
REC name
East of England - Cambridge Central Research Ethics Committee
REC reference
14/EE/1282
Date of REC Opinion
23 Feb 2015
REC opinion
Further Information Favourable Opinion