NCT03872882

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 22, 2017

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 13, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 13, 2017

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

March 11, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 13, 2019

Completed
Last Updated

November 8, 2019

Status Verified

November 1, 2019

Enrollment Period

9 months

First QC Date

March 11, 2019

Last Update Submit

November 6, 2019

Conditions

Hearing Loss

Keywords

Newborn hearing screeningHearing lossHearing screening equipment

Outcome Measures

Primary Outcomes (1)

  • 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

Eligibility Criteria

Age1 Day - 4 Days
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Babies undergoing newborn hearing screening

You may qualify if:

  • Babies requiring AABR testing through newborn hearing screening

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Norfolk & Norwich University Hospitals NHS Foundation Trust

Norwich, Norfolk, NR4 7UY, United Kingdom

Location

MeSH Terms

Conditions

Hearing Loss

Condition Hierarchy (Ancestors)

Hearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • John Fitzgerald, BSc (Hons)

    Consultant Audiologist

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Research Services Manager

Study Record Dates

First Submitted

March 11, 2019

First Posted

March 13, 2019

Study Start

March 22, 2017

Primary Completion

December 13, 2017

Study Completion

December 13, 2017

Last Updated

November 8, 2019

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)