ANSeR- The Algorithm for Neonatal Seizure Recognition Study

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02160171

Acronym

ANSeR

Enrollment

240

Registered

2014-06-10

Start date

2013-04-30

Completion date

2015-06-30

Last updated

2015-08-11

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

Conditions

Neonatal Seizures

Keywords

Decision Support Algorithm, Neonatal Seizures, EEG

Brief summary

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

Detailed 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.

Interventions

DEVICEAlgorithm for Neonatal Seizure Recognition

Software system for neonatal seizure detection recognition

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

36 Weeks to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
To quantify the overall diagnostic accuracy of the Algorithm.	up to 72 hours	To measure diagnostic accuracy of ANSeR (Algorithm) and clinicians (in routine clinical practice or optimised clinical practice) during the initial up to but not limited to 72 hour period of post-natal EEG monitoring, using an expert panel as the reference standard.

Secondary

Measure	Time frame	Description
Inappropriate use/non-use of Anti Epileptic Drugs (AEDs)	up to 72 hours	To quantify the degree and duration of inappropriate use/non-use of AEDs with 1. the off-line application of the ANSeR algorithm and 2. routine clinical practice. To compare (a) and (b).
To examine factors that influence diagnostic accuracy in clinical practice.	up to 72 hours	To examine factors that influence diagnostic accuracy in clinical practice.

Countries

Ireland, Netherlands, Sweden, United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 23, 2026