Accuscreen Equipment Evaluation For Newborn Hearing Screening

Status Completed

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.

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03872882
Study type	Observational
Source	Norfolk and Norwich University Hospitals NHS Foundation Trust
Contact
Status	Completed
Phase
Start date	March 22, 2017
Completion date	December 13, 2017

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT04696835` - fNIRS in Pediatric Hearing Aids	N/A
Completed	`NCT03662256` - Reducing Childhood Hearing Loss in Rural Alaska Through a Preschool Screening and Referral Process Using Mobile Health and Telemedicine	N/A
Completed	`NCT04602780` - Evaluating the Revised WORQ in CI Users
Completed	`NCT03723161` - Evaluation of the Ponto Bone Anchored Hearing System in a Pediatric Atresia Population
Completed	`NCT05086809` - Investigation of an Updated Bone-anchored Sound Processor	N/A
Active, not recruiting	`NCT03548779` - North Carolina Genomic Evaluation by Next-generation Exome Sequencing, 2	N/A
Completed	`NCT03428841` - Audiovisual Assessment After Dural Puncture During Epidural Placement in Obstetric Patients	N/A
Completed	`NCT04559282` - Home Test of New Sound Processor	N/A
Enrolling by invitation	`NCT03345654` - Individually-guided Hearing Aid Fitting
Completed	`NCT06016335` - MRI-based Synthetic CT Images of the Head and Neck	N/A
Completed	`NCT05165121` - Comparison of Hearing Aid Fitting Outcomes Between Self-fit and Professional Fit for MDHearing Smart Hearing Aids	N/A
Recruiting	`NCT05533840` - Establishment and Application of a New Imaging System for Otology Based on Ultra-high Resolution CT
Completed	`NCT04622059` - AUditive Direct In-utero Observation (AUDIO): Prenatal Testing of Congenital Hypoacusis	N/A
Terminated	`NCT02294812` - Effects of Cognitive Training on Speech Perception	N/A
Recruiting	`NCT02558478` - Identification of New Genes Implicated in Rare Neurosensory Diseases by Whole Exome Sequencing	N/A
Withdrawn	`NCT02740322` - Validating the Hum Test	N/A
Completed	`NCT01963104` - Community-Based Kiosks for Hearing Screening and Education	N/A
Completed	`NCT01892007` - Evaluation of Cogmed Working Memory Training for Adult Hearing Aid Users	N/A
Completed	`NCT01857661` - The Influence of the Sound Generator Combined With Conventional Amplification for Tinnitus Control: Blind Randomized Clinical Trial	N/A
Withdrawn	`NCT01223638` - The Prevalence of Hearing Loss Among Children With Congenital Hypothyroidism	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.