Status:
COMPLETED
Promoting Early Diagnosis of Congenital Hearing Loss With Patient Navigators
Lead Sponsor:
Matthew Bush, MD
Collaborating Sponsors:
National Institute on Deafness and Other Communication Disorders (NIDCD)
National Institutes of Health (NIH)
Conditions:
Congenital Hearing Loss
Eligibility:
All Genders
Phase:
NA
Brief Summary
Hearing loss is the most common sensory congenital disorder and this condition is diagnosable and treatable. Children that are born with hearing loss have to undergo several hearing tests to diagnose ...
Detailed Description
Parents of children who fail infant hearing screening at birth at the University of Kentucky or other hospitals in the area that are receiving follow up diagnostic testing at UK Audiology or the Commi...
Eligibility Criteria
Inclusion
- Inclusion Criteria (Arm 1):
- Parents of children who are born at University of Kentucky Medical Center in the postpartum ward whose children are born after 34 weeks gestation and fail hearing screening in one or both ears
- Parents whose children are receiving follow up testing (due to referral after mandatory newborn hearing screening) at UK Audiology or the Commission for Children with Special Health Care Needs
- Parents who are willing to be contacted by study coordinators and/or navigator to monitor progress and testing outcomes
- Parents who are able to speak English or Spanish as the patient navigator will be speaking one of these languages and this will be the primary means of communication over the phone.
- Exclusion Criteria (Arm 1):
- Parents of newborns who are hospitalized past 30 days after birth or who are born prior to 34 weeks gestation (as this may inherently delay diagnostic work-up)
- Children and parents live outside Kentucky or who will be moving out of Kentucky within the first year of life (they will not be able to be followed closely at our institution)
- Parents of wards of the state and cases of adoption will be excluded
- Inclusion Criteria (Arm 2):
- Children who are 6 months old or less and have been diagnosed with hearing loss in one or both ears through two separate ABR tests.
- Parents who are willing to be contacted by study coordinators and/or navigator to monitor progress and testing outcomes
- Parents who are able to speak English or Spanish as the patient navigator will be speaking one of these languages and this will be the primary means of communication over the phone.
- Exclusion Criteria (Arm 2):
- Parents of newborns who are hospitalized past 30 days after birth or who are born prior to 34 weeks gestation (as this may inherently delay diagnostic work-up)
- Children and parents live outside Kentucky or who will be moving out of Kentucky within the first year of life (they will not be able to be followed closely at our institution)
- Parents of wards of the state and cases of adoption will be excluded
Exclusion
Key Trial Info
Start Date :
January 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2020
Estimated Enrollment :
106 Patients enrolled
Trial Details
Trial ID
NCT01917747
Start Date
January 1 2014
End Date
January 1 2020
Last Update
March 31 2020
Active Locations (2)
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1
University of Kentucky
Lexington, Kentucky, United States, 40536
2
Commission for Children with Special Health Care Needs
Louisville, Kentucky, United States, 40222