NCT04040517

Brief Summary

All children with hearing loss should have access to resources necessary to reach their maximum potential. The following principles provide the foundation for effective EHDI\[Early Hearing Detection \& Intervention\] systems and have been updated and expanded since the 2000 JCIH \[ joint Committee on Infant Hearing \] position statement .

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2019

Status
unknown

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

First Submitted

Initial submission to the registry

May 21, 2019

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 31, 2019

Completed
4 months until next milestone

Study Start

First participant enrolled

December 1, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2020

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2021

Completed
Last Updated

July 31, 2019

Status Verified

July 1, 2019

Enrollment Period

6 months

First QC Date

May 21, 2019

Last Update Submit

July 30, 2019

Conditions

Hearing Impaired Children

Keywords

Hearing Loss

Outcome Measures

Primary Outcomes (1)

  • A 40 hearing impaired children with absent ABR waves

    evaluation by auditory steady state response (ASSR)

    one year

Secondary Outcomes (1)

  • After ASSR evaluation for this patient we can take decision either for hearing aid amplification of for (surgery) cochlear implant .

    one year

Interventions

Evoked potential audiometerDIAGNOSTIC_TEST

The ASSR \[ steady state response\] test stimuli are modulated pure tones with insert earphone..

Also known as: Auditory steady state response

Eligibility Criteria

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

Evaluate of residual hearing function in hearing impaired children with absent ABR waves and normal middle ear pressure.

You may qualify if:

  • Absent ABR \[Auditory Breanstem Response\] waves .
  • normal middle ear function

You may not qualify if:

  • Ears with otitis media with effusion,
  • Preserved otoacuastic emission ,
  • Preserved ABR waves .

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Wadhera R, Hernot S, Gulati SP, Kalra V. A controlled comparison of auditory steady-state responses and pure-tone audiometry in patients with hearing loss. Ear Nose Throat J. 2017 Oct-Nov;96(10-11):E47-E52. doi: 10.1177/0145561317096010-1109.

    PMID: 29121385BACKGROUND

MeSH Terms

Conditions

Hearing Loss

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Mohamed Salama Bakr, MD

CONTACT

01006550289mohamedsalamabakr@yahoo.com

Mohammad Mohammad El-Moursy, MD

CONTACT

01003615648moursy¬_audio2020@yahoo.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
resident doctor Alazhar university - Assiut

Study Record Dates

First Submitted

May 21, 2019

First Posted

July 31, 2019

Study Start

December 1, 2019

Primary Completion

June 1, 2020

Study Completion

January 1, 2021

Last Updated

July 31, 2019

Record last verified: 2019-07