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

NCT02431780 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 264

Last updated 2023-12-11

No results posted yet for this study

Summary

The ANSeR Clinical Investigation is a multi-centre, randomised, controlled, clinical investigation of a standalone decision support Algorithm for Neonatal Seizure Recognition, the ANSER Software system.

Conditions

Interventions

DEVICE

ANSeR Software System

ANSeR Software System a stand alone, software medical device for Neonatal seizure decision support tool

Sponsors & Collaborators

  • University College, London

    collaborator OTHER

  • Wellcome Trust

    collaborator OTHER

  • University College Cork

    lead OTHER

Principal Investigators

  • Janet Rennie, Doctor · University College London Hospitals

  • Geraldine Boylan, PhD · University College Cork, Cork, Ireland

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
36 Weeks
Max Age
44 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-02-12
Primary Completion
2017-02-07
Completion
2017-02-07

Countries

  • Ireland
  • Netherlands
  • Sweden
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02431780 on ClinicalTrials.gov