Back to resultsProactive Counselling Towards Follow-ups in Newborn Hearing Screening
Primary Purpose
Hearing Loss, Newborn Morbidity
Status
Withdrawn
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
counselling
Sponsored by
About this trial
This is an interventional prevention trial for Hearing Loss
Eligibility Criteria
Inclusion Criteria:
- The parents whose infants do not pass hearing screening
Exclusion Criteria:
- The parents whose infants have illnesses and are not ready for hearing screening
- The parents who decide to migrate to other areas
Sites / Locations
- Faculty of Medicine, Prince of Songkla University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Counselling arm
standard arm
Arm Description
Educating and Counselling are provided by a physician. Also, the information about hearing screening results and an appointment date are provided by a physician.
The information about hearing screening results and an appointment date are provided as a routine by either nurses or nurse assistances who perform the screening test.
Outcomes
Primary Outcome Measures
Number of participants with loss to follow-ups in all participants whose infants require follow-ups
A loss to follow-up rate which is calculated from number of participants with loss to follow-ups divided by number of all participants whose infants require follow-ups
Secondary Outcome Measures
Full Information
NCT ID
NCT04988061
First Posted
July 28, 2021
Last Updated
September 27, 2022
Sponsor
Prince of Songkla University
1. Study Identification
Unique Protocol Identification Number
NCT04988061
Brief Title
Proactive Counselling Towards Follow-ups in Newborn Hearing Screening
Official Title
Result of Proactive Parental Educating and Counselling Towards Follow-ups in Parents Whose Infant Fail Newborn Hearing Screening
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Withdrawn
Why Stopped
no subjects enrolled
Study Start Date
August 20, 2021 (Actual)
Primary Completion Date
July 31, 2023 (Anticipated)
Study Completion Date
January 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Prince of Songkla University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The study aims to investigate if proactive parental educating and counselling can minimize loss to follow-ups of parents whose infant fail newborn hearing screening.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Loss, Newborn Morbidity
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Counselling arm
Arm Type
Experimental
Arm Description
Educating and Counselling are provided by a physician. Also, the information about hearing screening results and an appointment date are provided by a physician.
Arm Title
standard arm
Arm Type
No Intervention
Arm Description
The information about hearing screening results and an appointment date are provided as a routine by either nurses or nurse assistances who perform the screening test.
Intervention Type
Other
Intervention Name(s)
counselling
Intervention Description
Educating and Counselling with personal communication for 10-15 minutes and written information about the importance of early identification and intervention for hearing loss are provided by a physician. Also, the information about hearing screening results and an appointment date are provided by a physician.
Primary Outcome Measure Information:
Title
Number of participants with loss to follow-ups in all participants whose infants require follow-ups
Description
A loss to follow-up rate which is calculated from number of participants with loss to follow-ups divided by number of all participants whose infants require follow-ups
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
The parents whose infants do not pass hearing screening
Exclusion Criteria:
The parents whose infants have illnesses and are not ready for hearing screening
The parents who decide to migrate to other areas
Facility Information:
Facility Name
Faculty of Medicine, Prince of Songkla University
City
Hat Yai
State/Province
Songkhla
ZIP/Postal Code
90110
Country
Thailand
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Proactive Counselling Towards Follow-ups in Newborn Hearing Screening
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