Accuscreen Equipment Evaluation For Newborn Hearing Screening

• ClinicalTrials.gov Identifier: NCT03872882
• Recruitment Status: Completed
• First Posted: March 13, 2019
• Last Update Posted: November 8, 2019
• Sponsor: Julie Dawson
• Collaborators: University of East Anglia; GN Otometrics
• Information provided by (Responsible Party): Julie Dawson, Norfolk and Norwich University Hospitals NHS Foundation Trust

Tracking Information

• First Submitted Date: March 11, 2019
• First Posted Date: March 13, 2019
• Last Update Posted Date: November 8, 2019
• Actual Study Start Date: March 22, 2017
• Actual Primary Completion Date: December 13, 2017 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: March 11, 2019)

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.

• Original Primary Outcome Measures: Same as current
• Change History: Complete list of historical versions of study NCT03872882 on ClinicalTrials.gov Archive Site
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Accuscreen Equipment Evaluation For Newborn Hearing Screening
• 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

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.

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 Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Cross-Sectional
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Non-Probability Sample
• Study Population: Babies undergoing newborn hearing screening
• Condition: Hearing Loss
• Intervention: Not Provided
• Study Groups/Cohorts: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: March 11, 2019): 100
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: December 13, 2017
• Actual Primary Completion Date: December 13, 2017 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Babies requiring AABR testing through newborn hearing screening

Exclusion Criteria:

-

Sex/Gender

• Sexes Eligible for Study: All

• Ages: up to 4 Days (Child)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United Kingdom

Administrative Information

• NCT Number: NCT03872882
• Other Study ID Numbers: 214416
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: Julie Dawson, Norfolk and Norwich University Hospitals NHS Foundation Trust
• Study Sponsor: Julie Dawson

Collaborators

• University of East Anglia
• GN Otometrics

Investigators

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

• PRS Account: Norfolk and Norwich University Hospitals NHS Foundation Trust
• Verification Date: November 2019