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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03872882
Other study ID # 214416
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 22, 2017
Est. completion date December 13, 2017

Study information

Verified date November 2019
Source Norfolk and Norwich University Hospitals NHS Foundation Trust
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date December 13, 2017
Est. primary completion date December 13, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A to 4 Days
Eligibility Inclusion Criteria:

- Babies requiring AABR testing through newborn hearing screening

Exclusion Criteria:

-

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United Kingdom Norfolk & Norwich University Hospitals NHS Foundation Trust Norwich Norfolk

Sponsors (3)

Lead Sponsor Collaborator
Julie Dawson GN Otometrics, University of East Anglia

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Screen pass or screen refer The referral rate is the number of babies who do not pass the newborn hearing screen. within 48 hours of birth
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