Hearing LossNCT04988061
Proactive Counselling Towards Follow-ups in Newborn Hearing Screening
A study testing counselling in people with Hearing Loss and Newborn Morbidity, run by Prince of Songkla University at 1 site in Thailand.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hearing Loss, Newborn Morbidity
- What is being tested?
- counselling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteThailand
- Study dates
- 20 Aug 2021to 31 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The parents whose infants do not pass hearing screening
Who cannot join
- The parents whose infants have illnesses and are not ready for hearing screening
- The parents who decide to migrate to other areas
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Faculty of Medicine, Prince of Songkla University
Hat Yai, Changwat Songkhla, 90110
About this study
Official title: Result of Proactive Parental Educating and Counselling Towards Follow-ups in Parents Whose Infant Fail Newborn Hearing Screening
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.
- Conditions
- Hearing Loss, Newborn Morbidity
- Being tested
- counselling
- Medical subject headings
- Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
counsellingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Counselling arm | Experimental | Educating and Counselling are provided by a physician. Also, the information about hearing screening results and an appointment date are provided by a physician. Receives: Other: counselling |
| standard arm | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2021
- Study start20 Aug 2021
- Primary completion31 Jul 2023 (estimated)
- Study completion31 Jan 2024 (estimated)
Why it stopped: no subjects enrolled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hearing LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prince of Songkla University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pittayapon Pitathawatchai, Prince of Songkla University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04988061
- Sponsor's protocol ID
- 64-220-13-1
- Status last verified
- Sep 2022
- First submitted
- 28 Jul 2021
- Last updated
- 29 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Result of Proactive Parental Educating and Counselling Towards Follow-ups in Parents Whose Infant Fail Newborn Hearing Screening
- ClinicalTrials.gov ID
- NCT04988061
- Acronym / sponsor ID
- 64-220-13-1
- Conditions
- Hearing Loss, Newborn Morbidity
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: no subjects enrolled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Prince of Songkla UniversityUniversity, hospital or other
- Study start
- 20 Aug 2021 (actual)
- Primary completion
- 31 Jul 2023 (estimated)
- Study completion
- 31 Jan 2024 (estimated)
- First posted
- 3 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Counselling arm | Experimental | Other: counsellingEducating and Counselling are provided by a physician. Also, the information about hearing screening results and an appointment date are provided by a physician. |
| standard arm | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- The parents whose infants do not pass hearing screening
Key exclusion criteria (2 listed)
- The parents whose infants have illnesses and are not ready for hearing screening
- The parents who decide to migrate to other areas
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| counsellingEducating 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. | Other | Counselling arm |
Primary outcome
Number of participants with loss to follow-ups in all participants whose infants require follow-ups
Time frame: 6 months
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing counselling in people with Hearing Loss and Newborn Morbidity, run by Prince of Songkla University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 29 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with loss to follow-ups in all participants whose infants require follow-ups (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2022.