Accuscreen Equipment Evaluation For Newborn Hearing Screening

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.

Completed

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Key information

Conditions

Hearing Loss Ear Diseases Hearing Disorders Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms

Age range

1 day–4 day

Sex eligibility

All sexes

Study type

Observational

Primary location

Norfolk & Norwich University Hospitals NHS Foundation Trust

Norwich, Norfolk, NR4 7UY, United Kingdom

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Babies requiring AABR testing through newborn hearing screening

Exclusion criteria

Treatment and study plan

Primary outcomes

Screen pass or screen refer

Time frame: within 48 hours of birth

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

Sponsors and collaborators

Lead sponsor

Julie Dawson

Other

Collaborators

GN Otometrics
University of East Anglia

Registry information

Official study 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

Important dates

Study start: 2017
Primary completion: 2017
Study completion: 2017
First posted: Mar 13, 2019
Registry last updated: Nov 8, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed