<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03251638</url>
  </required_header>
  <id_info>
    <org_study_id>Assuit</org_study_id>
    <nct_id>NCT03251638</nct_id>
  </id_info>
  <brief_title>Neonatal Hearing Screening in Assiut Hospital</brief_title>
  <official_title>Neonatal Hearing Screening at Neonatal Intensive Care Unit of Assiut University Hospital</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Hearing loss is one of the most common congenital anomalies. Early Intervention at or before&#xD;
      6 months of age allows a child with impaired hearing to develop normal speech and&#xD;
      language.Auditory brainstem response , otoacoustic emissions testing have all been used in&#xD;
      newborn hearing-screening programs&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Hearing loss is one of the most common congenital anomalies . It has been shown to be greater&#xD;
      than that of most other diseases and syndromes (eg, phenylketonuria, sickle cell disease)&#xD;
      screened at birth . Data from the newborn hearing-screening programs in Rhode Island,&#xD;
      Colorado, and Texas showed that 2-4 of every 1000 neonates have hearing loss.&#xD;
&#xD;
      Early Intervention at or before 6 months of age allows a child with impaired hearing to&#xD;
      develop normal speech and language, alongside his or her hearing peers and can prevent severe&#xD;
      psychosocial, educational, and language impairment.( One of the most high risk population are&#xD;
      neonates who spend time in the newborn intensive care unit, exposed to high frequency&#xD;
      ventilation, hyperbilirubinemia, low birth-weight, and exposed to ototoxic medications.&#xD;
&#xD;
      Auditory brainstem response, otoacoustic emissions , and automated Auditory brainstem&#xD;
      response testing have all been used in newborn hearing-screening programs. otoacoustic&#xD;
      emissions are fast objective, efficient, and frequency-specific measurements of peripheral&#xD;
      auditory sensitivity are used to assess response of the outer hair cells to acoustic stimuli.&#xD;
      To measure otoacoustic emissions, a probe assembly is placed in the ear canal, tonal or click&#xD;
      stimuli are delivered, and the otoacoustic emissions generated by the cochlea is measured&#xD;
      with a microphone .&#xD;
&#xD;
      Currently, 2 types of evoked otoacoustic emissions measurements are used for newborn hearing&#xD;
      screening: transient evoked otoacoustic emissions and distortion product otoacoustic&#xD;
      emissions . Provided that the patient's middle ear function is normal, these measurements can&#xD;
      be used to assess cochlear function for the 500-6000 Hz frequency range. The presence of&#xD;
      evoked otoacoustic emissions responses indicates hearing sensitivity in the normal to&#xD;
      near-normal range .&#xD;
&#xD;
      The Auditory brainstem response test records brainstem electrical activity in response to&#xD;
      sounds presented to the infant via earphones. In contrast to the otoacoustic emissions test,&#xD;
      the The Auditory brainstem response evaluates the auditory pathway from the external ear to&#xD;
      the level of the brainstem, enabling diagnosis of auditory neuropathy, which is a less common&#xD;
      cause of hearing impairment .&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">March 2018</start_date>
  <completion_date type="Anticipated">November 2018</completion_date>
  <primary_completion_date type="Anticipated">September 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Neonatal hearing screening</measure>
    <time_frame>6months</time_frame>
    <description>number of neonates who failed to pass emissions</description>
  </primary_outcome>
  <enrollment type="Anticipated">300</enrollment>
  <condition>Neonatal Hearing Impairment</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Neonates who admitted at neonatal intensive care unit&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  A) Neonates of both sexes. (B) Neonates with the following risk factors according to&#xD;
             the Joint Committee on Infant Hearing 2000 Position Statement:&#xD;
&#xD;
               -  In utero infection such as cytomegalovirus, rubella, toxoplasmosis, or herpes.&#xD;
&#xD;
               -  Neonatal indicators, specifically hyperbilirubinemia at a serum level requiring&#xD;
                  exchange transfusion, persistent pulmonary hypertension of the newborn associated&#xD;
                  with mechanical ventilation, and conditions requiring the use of extracorporeal&#xD;
                  membrane oxygenation&#xD;
&#xD;
               -  Low birth weight (1500-1800)grams&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  • Absence of high risk factors in the neonates.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Day</minimum_age>
    <maximum_age>1 Month</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Nafesa Hs Rafat, Prof</last_name>
    <role>Study Director</role>
  </overall_official>
  <overall_contact>
    <last_name>Eman AF Sayed, As.Prof</last_name>
    <phone>0201156383841</phone>
    <email>emanelgendy40@yahoo.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Samah M Ahmed, lecturer</last_name>
    <phone>0201003272437</phone>
    <email>Samahoraky@yahoo.com</email>
  </overall_contact_backup>
  <results_reference>
    <citation>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.</citation>
    <PMID>15689741</PMID>
  </results_reference>
  <results_reference>
    <citation>Downs 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.</citation>
    <PMID>7665273</PMID>
  </results_reference>
  <results_reference>
    <citation>Erenberg 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.</citation>
    <PMID>9925859</PMID>
  </results_reference>
  <results_reference>
    <citation>Finitzo 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.</citation>
    <PMID>9832584</PMID>
  </results_reference>
  <results_reference>
    <citation>Williams 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.</citation>
    <PMID>25856256</PMID>
  </results_reference>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 12, 2017</study_first_submitted>
  <study_first_submitted_qc>August 12, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 16, 2017</study_first_posted>
  <last_update_submitted>August 19, 2017</last_update_submitted>
  <last_update_submitted_qc>August 19, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 22, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Nesma Gamal</investigator_full_name>
    <investigator_title>Neonatal Hearing Screeing at Neonatal Intensive Care Unit of Assiut University Hospital</investigator_title>
  </responsible_party>
  <keyword>NHS( newborn hearing screening )</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hearing Loss</mesh_term>
    <mesh_term>Deafness</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03251638
org study id: Assuit
nct id: NCT03251638
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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
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 .
observational model: Other
time perspective: Prospective
measure: Neonatal hearing screening
time frame: 6months
description: number of neonates who failed to pass emissions
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 1 Day
maximum age: 1 Month
last name: Nafesa Hs Rafat, Prof
role: Study Director
last name: Eman AF Sayed, As.Prof
phone: 0201156383841
email: emanelgendy40@yahoo.com
last name: Samah M Ahmed, lecturer
phone: 0201003272437
email: Samahoraky@yahoo.com
citation: 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.
PMID: 15689741
citation: Downs 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.
PMID: 7665273
citation: Erenberg 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.
PMID: 9925859
citation: Finitzo 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.
PMID: 9832584
citation: Williams 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.
PMID: 25856256
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: Nesma Gamal
investigator title: Neonatal Hearing Screeing at Neonatal Intensive Care Unit of Assiut University Hospital
mesh term: Hearing Loss
mesh term: Deafness