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Accuscreen Equipment Evaluation For Newborn Hearing Screening

Sponsor
Julie Dawson (Other)
Overall Status
Completed
CT.gov ID
NCT03872882
Collaborator
University of East Anglia (Other), GN Otometrics (Other)
100
Enrollment
1
Location
8.7
Actual Duration (Months)
11.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

An evaluation and comparison of results between the 'Accuscreen New' currently in use and an 'Accuscreen New' with different settings to see if the new settings reduce unnecessary referrals for babies from newborn hearing screening.

Babies will be tested with the standard and modified equipment. Referrals for diagnostic testing will be based on the standard equipment. A comparison in referrals between the standard and modified equipment will be made.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    All newborn babies undergo hearing screening, usually within the first few days of life and some are tested with the automated auditory brainstem response test (AABR). This involves recording activity from the hearing nerve and parts of the brainstem from three small sensors placed on the baby's head and neck when a series of clicking sounds are played in to the ear.

    In March 2015 we started using an 'Accuscreen New' to record the AABR, which is approved by the Newborn Hearing Screening Programme (NHSP) and used widely across the UK. However, since introducing the new equipment the 'screen refer' rate increased significantly in very young babies (less than 48 hours old) and diagnostic testing showed they had satisfactory hearing. The impact of the increased referral rate caused increased delays on diagnostic testing and also lead to unnecessarily increased parental anxiety in relation to the hearing of their new born baby.

    The equipment suppliers (GN Otometrics) and the NHSP Programme centre have agreed to an evaluation and comparison of results between the 'Accuscreen New' currently in use and an 'Accuscreen New' with different settings which we believe will reduce unnecessary referrals of so many young babies to Audiology (the modified equipment will test for up to 10 minutes to see if a response is present, instead of stopping after one or two minutes).

    Babies will be tested with the standard and modified equipment. Referrals for diagnostic testing will be based on the standard equipment. A comparison in referrals between the standard and modified equipment will be made.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    100 participants
    Observational Model:
    Cohort
    Time Perspective:
    Cross-Sectional
    Official Title:
    Equipment Evaluation for Newborn Hearing Screening. A Randomised Comparison of Screen Outcome Between Standard Madsen 'Accuscreen New' and Madsen 'Accuscreen New' With Fast Refer Disabled and Increased Test Time
    Actual Study Start Date :
    Mar 22, 2017
    Actual Primary Completion Date :
    Dec 13, 2017
    Actual Study Completion Date :
    Dec 13, 2017

    Outcome Measures

    Primary Outcome Measures

    1. Screen pass or screen refer [within 48 hours of birth]

      The referral rate is the number of babies who do not pass the newborn hearing screen.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    1 Day to 4 Days
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Babies requiring AABR testing through newborn hearing screening
    Exclusion Criteria:

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Norfolk & Norwich University Hospitals NHS Foundation Trust Norwich Norfolk United Kingdom NR4 7UY

    Sponsors and Collaborators

    • Julie Dawson
    • University of East Anglia
    • GN Otometrics

    Investigators

    • Principal Investigator: John Fitzgerald, BSc (Hons), Consultant Audiologist

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Julie Dawson, Research Services Manager, Norfolk and Norwich University Hospitals NHS Foundation Trust
    ClinicalTrials.gov Identifier:
    NCT03872882
    Other Study ID Numbers:
    • 214416
    First Posted:
    Mar 13, 2019
    Last Update Posted:
    Nov 8, 2019
    Last Verified:
    Nov 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Julie Dawson, Research Services Manager, Norfolk and Norwich University Hospitals NHS Foundation Trust
    Newborn hearing screening
    Hearing loss
    Hearing screening equipment
    Additional relevant MeSH terms:
    Hearing Loss
    Deafness

    Study Results

    No Results Posted as of Nov 8, 2019