Neonatal Hearing ImpairmentNCT03251638
Neonatal Hearing Screening in Assiut Hospital
An observational study of Neonatal Hearing Impairment, run by Assiut University.
Trial summary
Hearing loss is one of the most common congenital anomalies. Early Intervention at or before 6 months of age allows a child with impaired hearing to develop normal speech and language.Auditory brainstem response , otoacoustic emissions testing have all been used in newborn hearing-screening programs Read more about this study
- Who is it for?
- Ages 1 day to 1 month
- Conditions the study is for
- Neonatal Hearing Impairment
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- Mar 2018to Nov 2018
- 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 day to 1 month
- All sexes
- Child
Study population: Neonates who admitted at neonatal intensive care unit
Who may be able to join
- A) Neonates of both sexes. (B) Neonates with the following risk factors according to the Joint Committee on Infant Hearing 2000 Position Statement:
- In utero infection such as cytomegalovirus, rubella, toxoplasmosis, or herpes.
- Neonatal indicators, specifically hyperbilirubinemia at a serum level requiring exchange transfusion, persistent pulmonary hypertension of the newborn associated with mechanical ventilation, and conditions requiring the use of extracorporeal membrane oxygenation
- Low birth weight (1500-1800)grams
Who cannot join
- • Absence of high risk factors in the neonates.
Trial locations and contacts
No sites are listed yet.
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. Early Intervention at or before 6 months of age allows a child with impaired hearing to develop normal speech and language.Auditory brainstem response , otoacoustic emissions testing have all been used in newborn hearing-screening programs
Read the detailed description
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 .
Currently, 2 types of evoked otoacoustic emissions measurements are used for newborn hearing screening: transient evoked otoacoustic emissions and distortion product otoacoustic emissions . Provided that the patient's middle ear function is normal, these measurements can be used to assess cochlear function for the 500-6000 Hz frequency range. The presence of evoked otoacoustic emissions responses indicates hearing sensitivity in the normal to near-normal range .
The Auditory brainstem response test records brainstem electrical activity in response to sounds presented to the infant via earphones. In contrast to the otoacoustic emissions test, the The Auditory brainstem response evaluates the auditory pathway from the external ear to the level of the brainstem, enabling diagnosis of auditory neuropathy, which is a less common cause of hearing impairment .
- Conditions
- Neonatal Hearing Impairment
- Keywords
- NHS( newborn hearing screening )
What is being measured
The primary outcome is the main question the study is designed to answer.
Neonatal hearing screening
number of neonates who failed to pass emissions
Measured: 6months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2017
- Study startMar 2018 (estimated)
- Primary completionSep 2018 (estimated)
- Study completionNov 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Neonatal Hearing ImpairmentStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nesma Gamal, Assiut University
- Investigators
- Nafesa Hs Rafat, Prof, Study director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03251638
- Sponsor's protocol ID
- Assuit
- Status last verified
- Aug 2017
- First submitted
- 12 Aug 2017
- Last updated
- 22 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Connolly JL, Carron JD, Roark SD. Universal newborn hearing screening: are we achieving the Joint Committee on Infant Hearing (JCIH) objectives? Laryngoscope. 2005 Feb;115(2):232-6. doi: 10.1097/01.mlg.0000154724.00787.49.
PubMed 15689741Downs MP. Universal newborn hearing screening--the Colorado story. Int J Pediatr Otorhinolaryngol. 1995 Jul;32(3):257-9. doi: 10.1016/0165-5876(95)01183-c.
PubMed 7665273Erenberg A, Lemons J, Sia C, Trunkel D, Ziring P. Newborn and infant hearing loss: detection and intervention.American Academy of Pediatrics. Task Force on Newborn and Infant Hearing, 1998- 1999. Pediatrics. 1999 Feb;103(2):527-30. doi: 10.1542/peds.103.2.527.
PubMed 9925859Finitzo T, Albright K, O'Neal J. The newborn with hearing loss: detection in the nursery. Pediatrics. 1998 Dec;102(6):1452-60. doi: 10.1542/peds.102.6.1452.
PubMed 9832584Williams TR, Alam S, Gaffney M; Centers for Disease Control and Prevention (CDC). Progress in identifying infants with hearing loss-United States, 2006-2012. MMWR Morb Mortal Wkly Rep. 2015 Apr 10;64(13):351-6.
PubMed 25856256
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2017. 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
- NCT03251638
- Acronym / sponsor ID
- Assuit
- Conditions
- Neonatal Hearing Impairment
- Keywords
- NHS( newborn hearing screening )
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Mar 2018 (estimated)
- Primary completion
- Sep 2018 (estimated)
- Study completion
- Nov 2018 (estimated)
- First posted
- 16 Aug 2017 (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. Early Intervention at or before 6 months of age allows a child with impaired hearing to develop normal speech and language.Auditory brainstem response , otoacoustic emissions testing have all been used in newborn hearing-screening programs
Detailed description
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 .
Currently, 2 types of evoked otoacoustic emissions measurements are used for newborn hearing screening: transient evoked otoacoustic emissions and distortion product otoacoustic emissions . Provided that the patient's middle ear function is normal, these measurements can be used to assess cochlear function for the 500-6000 Hz frequency range. The presence of evoked otoacoustic emissions responses indicates hearing sensitivity in the normal to near-normal range .
The Auditory brainstem response test records brainstem electrical activity in response to sounds presented to the infant via earphones. In contrast to the otoacoustic emissions test, the The Auditory brainstem response evaluates the auditory pathway from the external ear to the level of the brainstem, enabling diagnosis of auditory neuropathy, which is a less common cause of hearing impairment .
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 day to 1 month
- Sex
- All
- Age groups
- Child
- Study population
- Neonates who admitted at neonatal intensive care unit
Key inclusion criteria (4 listed)
- A) Neonates of both sexes. (B) Neonates with the following risk factors according to the Joint Committee on Infant Hearing 2000 Position Statement:
Key exclusion criteria (1 listed)
- • Absence of high risk factors in the neonates.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Neonatal hearing screening
Time frame: 6months
number of neonates who failed to pass emissions
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2017.
- Results publication: PubMed 15689741Connolly JL, Carron JD, Roark SD. Universal newborn hearing screening: are we achieving the Joint Committee on Infant Hearing (JCIH) objectives? Laryngoscope. 2005 Feb;115(2):232-6. doi: 10.1097/01.mlg.0000154724.00787.49.
- Results publication: PubMed 7665273Downs MP. Universal newborn hearing screening--the Colorado story. Int J Pediatr Otorhinolaryngol. 1995 Jul;32(3):257-9. doi: 10.1016/0165-5876(95)01183-c.
- Results publication: PubMed 9925859Erenberg A, Lemons J, Sia C, Trunkel D, Ziring P. Newborn and infant hearing loss: detection and intervention.American Academy of Pediatrics. Task Force on Newborn and Infant Hearing, 1998- 1999. Pediatrics. 1999 Feb;103(2):527-30. doi: 10.1542/peds.103.2.527.
- Results publication: PubMed 9832584Finitzo T, Albright K, O'Neal J. The newborn with hearing loss: detection in the nursery. Pediatrics. 1998 Dec;102(6):1452-60. doi: 10.1542/peds.102.6.1452.
- Results publication: PubMed 25856256Williams TR, Alam S, Gaffney M; Centers for Disease Control and Prevention (CDC). Progress in identifying infants with hearing loss-United States, 2006-2012. MMWR Morb Mortal Wkly Rep. 2015 Apr 10;64(13):351-6.
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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.
Nafesa Hs Rafat, Prof study director
Questions about this trial
What is this clinical trial studying?
An observational study of Neonatal Hearing Impairment, run by Assiut University.
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 4 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: status not confirmed, as of the sponsor's last update on 22 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eman AF Sayed, As.Prof (0201156383841, emanelgendy40@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neonatal hearing screening (time frame: 6months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03251638, which also lists 5 linked publications.
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 22 Aug 2017.