Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Neonatal Hearing Screening at Neonatal Intensive Care Unit

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03716362
Recruitment Status : Not yet recruiting
First Posted : October 23, 2018
Last Update Posted : October 23, 2018
Sponsor:
Information provided by (Responsible Party):
Mohammed Khairy Ali, Assiut University

Tracking Information
First Submitted Date October 21, 2018
First Posted Date October 23, 2018
Last Update Posted Date October 23, 2018
Estimated Study Start Date November 1, 2018
Estimated Primary Completion Date October 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 21, 2018)
Prevalence of hearing loss in all neonates in Neonatal Intensive Care Unit [ Time Frame: 1 year ]
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Neonatal Hearing Screening at Neonatal Intensive Care Unit
Official Title Neonatal Hearing Screening at Neonatal Intensive Care Unit of Assiut University Hospital
Brief 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. 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 .

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Crossover
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population This study will conduct on neonates who will be admitted at intensive care unit
Condition Hearing Loss
Intervention Device: Otoacoustic emissions device
as a screening tool for Auditory brainstem response
Study Groups/Cohorts Neonates who will be admitted at Neonatal Intensive Care Unite
Intervention: Device: Otoacoustic emissions device
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Not yet recruiting
Estimated Enrollment
 (submitted: October 21, 2018)
300
Original Estimated Enrollment Same as current
Estimated Study Completion Date November 2019
Estimated Primary Completion Date October 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • neonates whose parent refuse to participate in the study.
Sex/Gender
Sexes Eligible for Study: All
Ages up to 4 Weeks   (Child)
Accepts Healthy Volunteers Not Provided
Contacts
Listed Location Countries Egypt
Removed Location Countries  
 
Administrative Information
NCT Number NCT03716362
Other Study ID Numbers NHS
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Mohammed Khairy Ali, Assiut University
Study Sponsor Assiut University
Collaborators Not Provided
Investigators Not Provided
PRS Account Assiut University
Verification Date October 2018