Hearing LossNCT03716362
Neonatal Hearing Screening at Neonatal Intensive Care Unit
An observational study of Hearing Loss, run by Assiut University at 1 site in Egypt.
Trial summary
Hearing loss is one of the most common congenital anomalies . It has been shown to be greater than that of most other diseases and syndromes (eg, phenylketonuria, sickle cell disease) screened at birth. Read more about this study
- Who is it for?
- Ages 1 week to 4 weeks
- Conditions the study is for
- Hearing Loss
- What is being tested?
- Otoacoustic emissions device
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2018to Nov 2019
- Phase
- Observational
- 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 1 week to 4 weeks
- All sexes
- Child
Study population: This study will conduct on neonates who will be admitted at intensive care unit
Who may be able to join
- Neonates of both sexes.
- Neonates with In utero infection such as cytomegalovirus, rubella, toxoplasmosis, or herpes.
- Neonatal indicators, specifically hyperbilirubinemia at a serum level requiring exchange transfusion.
Who cannot join
- neonates whose parent refuse to participate in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Neonatal Hearing Screening at Neonatal Intensive Care Unit of Assiut University Hospital
Hearing loss is one of the most common congenital anomalies . It has been shown to be greater than that of most other diseases and syndromes (eg, phenylketonuria, sickle cell disease) screened at birth. Data from the newborn hearing-screening programs in Rhode Island, Colorado, and Texas showed that 2-4 of every 1000 neonates have hearing loss.
Early Intervention at or before 6 months of age allows a child with impaired hearing to develop normal speech and language, alongside his or her hearing peers and can prevent severe psychosocial, educational, and language impairment.
Read more
One of the most high risk population are neonates who spend time in the newborn intensive care unit , exposed to high frequency ventilation, hyperbilirubinemia, low birth-weight, and exposed to ototoxic medications.
Auditory brainstem response , otoacoustic emissions , and automated Auditory brainstem response testing have all been used in newborn hearing-screening programs. otoacoustic emissions are fast objective, efficient, and frequency-specific measurements of peripheral auditory sensitivity are used to assess response of the outer hair cells to acoustic stimuli. To measure otoacoustic emissions, a probe assembly is placed in the ear canal, tonal or click stimuli are delivered, and the otoacoustic emissions generated by the cochlea is measured with a microphone .
- Conditions
- Hearing Loss
- Being tested
- Otoacoustic emissions device
- Medical subject headings
- Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Otoacoustic emissions deviceDevice
as a screening tool for Auditory brainstem response
| Study group | Role | What they receive |
|---|---|---|
| Neonates who will be admitted at Neonatal Intensive Care Unite | Not described Receives: Device: Otoacoustic emissions device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of hearing loss in all neonates in Neonatal Intensive Care Unit
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2018
- Study start1 Nov 2018 (estimated)
- Primary completionOct 2019 (estimated)
- Study completionNov 2019 (estimated)
Why it stopped: no participant
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.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Khairy Ali, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03716362
- Sponsor's protocol ID
- NHS
- Status last verified
- Jul 2024
- First submitted
- 21 Oct 2018
- Last updated
- 31 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neonatal Hearing Screening at Neonatal Intensive Care Unit of Assiut University Hospital
- ClinicalTrials.gov ID
- NCT03716362
- Acronym / sponsor ID
- NHS
- Conditions
- Hearing Loss
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: no participant
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Nov 2018 (estimated)
- Primary completion
- Oct 2019 (estimated)
- Study completion
- Nov 2019 (estimated)
- First posted
- 23 Oct 2018 (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.
Hearing loss is one of the most common congenital anomalies . It has been shown to be greater than that of most other diseases and syndromes (eg, phenylketonuria, sickle cell disease) screened at birth. Data from the newborn hearing-screening programs in Rhode Island, Colorado, and Texas showed that 2-4 of every 1000 neonates have hearing loss.
Early Intervention at or before 6 months of age allows a child with impaired hearing to develop normal speech and language, alongside his or her hearing peers and can prevent severe psychosocial, educational, and language impairment.
One of the most high risk population are neonates who spend time in the newborn intensive care unit , exposed to high frequency ventilation, hyperbilirubinemia, low birth-weight, and exposed to ototoxic medications.
Auditory brainstem response , otoacoustic emissions , and automated Auditory brainstem response testing have all been used in newborn hearing-screening programs. otoacoustic emissions are fast objective, efficient, and frequency-specific measurements of peripheral auditory sensitivity are used to assess response of the outer hair cells to acoustic stimuli. To measure otoacoustic emissions, a probe assembly is placed in the ear canal, tonal or click stimuli are delivered, and the otoacoustic emissions generated by the cochlea is measured with a microphone .
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neonates who will be admitted at Neonatal Intensive Care Unite | – | Device: Otoacoustic emissions device |
Who may qualify
- Ages
- 1 week to 4 weeks
- Sex
- All
- Age groups
- Child
- Study population
- This study will conduct on neonates who will be admitted at intensive care unit
Key inclusion criteria (3 listed)
- Neonates of both sexes.
- Neonates with In utero infection such as cytomegalovirus, rubella, toxoplasmosis, or herpes.
- Neonatal indicators, specifically hyperbilirubinemia at a serum level requiring exchange transfusion.
Key exclusion criteria (1 listed)
- neonates whose parent refuse to participate in the study.
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 |
|---|---|---|
| Otoacoustic emissions deviceas a screening tool for Auditory brainstem response | Device | Neonates who will be admitted at Neonatal Intensive Care Unite |
Primary outcome
Prevalence of hearing loss in all neonates in Neonatal Intensive Care Unit
Time frame: 1 year
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 31 Jul 2024.
- Individual participant dataSharing planned: Undecided
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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?
An observational study of Hearing Loss, run by Assiut University at 1 site in Egypt.
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 3 inclusion and 1 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 31 Jul 2024. 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 Egypt. 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?
Prevalence of hearing loss in all neonates in Neonatal Intensive Care Unit (time frame: 1 year). 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 31 Jul 2024.