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CTRI Number  CTRI/2024/03/064665 [Registered on: 22/03/2024] Trial Registered Prospectively
Last Modified On: 20/03/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Screening 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Feasibility and accuracy of Fetal Vibroacoustic Stimulation as prenatal hearing screening tool  
Scientific Title of Study   A prospective cohort study to evaluate the feasibility and accuracy of Fetal Vibroacoustic Stimulation as prenatal hearing screening tool  
Trial Acronym  NILL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Vikas 
Designation  Junior Resident 
Affiliation  AIIMS, NEW DELHI 
Address  Dept of otorhinolaryngology and head and neck surgery, AIIMS, NEW DELHI
4th floor teaching block, room no - 4057, AIIMS,ANSARI NAGAR, NEW DELHI
New Delhi
DELHI
110029
India 
Phone  09461208976  
Fax    
Email  vikas20svm98@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Prem Sagar 
Designation  Additional Professor 
Affiliation  AIIMS, NEW DELHI 
Address  Department of Otorhinolaryngology and head and neck surgery, AIIMS NEW DELHI
4th floor teaching block room no 4057, AIIMS, ANSARI NAGAR, NEW DELHI
New Delhi
DELHI
110029
India 
Phone  8130069892  
Fax    
Email  sagardrprem@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Prem Sagar 
Designation  Additional Professor 
Affiliation  AIIMS, NEW DELHI 
Address  Department of Otorhinolaryngology and head and neck surgery, AIIMS NEW DELHI
4th floor teaching block, room no- 4057, AIIMS, ANSARI NAGAR, NEW DELHI
New Delhi
DELHI
110029
India 
Phone  08130069892  
Fax    
Email  sagardrprem@gmail.com  
 
Source of Monetary or Material Support  
AIIMS, NEW DELHI 
 
Primary Sponsor  
Name  AIIMS NEW DELJI 
Address  ANSARI NAGAR, NEW DELHI 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Vikas  AIIMS, NEW DELHI  Room no-19, ground floor,USG room, Mother and child block, AIIMS, NEW DELHI
New Delhi
DELHI 
09461208976

vikas20svm98@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
AIIMS  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Pregnancy 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  prenatal hearing screening  prenatal hearing screening using vibroacoustic stimulation Duration of test- 3min 30seconds after screening USG  
Comparator Agent  prenatal hearing screening using vibroacoustic stimulation   prenatal hearing screening using vibroacoustic stimulation compared to neonatal hearing screening using OAE/ BERA 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  Pregnant females visiting ANC planned for inhospital delivery 
 
ExclusionCriteria 
Details  multiple pregnancy, fetus with gross fetal malformation 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Accuracy of fetal vibroacoustic stimulation as a prenatal hearing screening tool compared to neonatal hearing screening tools   Prenatal hearing screening between 30weeks to 38weeks
Neonatal hearing screening between day 0 to day 10 of delivery 
 
Secondary Outcome  
Outcome  TimePoints 
Feasibilty of fetal vibroacoustic stimulation as a prenatal hearing screening tool   Prenatal hearing screening at 30 to 38 weeks of POG, OAE/BERA within 1st week post delivery  
 
Target Sample Size   Total Sample Size="736"
Sample Size from India="736" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   01/04/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="7"
Days="10" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [vikas20svm98@gmail.com].

  6. For how long will this data be available start date provided 01-12-2025 and end date provided 31-12-2030?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   Although neonatal screening tests for hearing loss are available, prenatal screening tests for the assessment of hearing loss are currently not routinely performed. The detection of hearing loss in the prenatal period might allow in earlier detection and management of hearing loss, given that the development of the auditory system begins in the fetal period as early as the 16th weeks of gestation. We therefore would like to assess if Fetal Vibroacoustic Stimulation as prenatal hearing screening tool could be more practical and effective tools for early detection of hearing loss.

•                Optimal intensity, frequency and tools for vibroacoustic stimulation (by study on 10 fetuses) 2000Hz at 85dB, 90dB, 95dB will be finalised before the beginning of the study on the recruited patients.

•                Pregnant women (fulfilling the inclusion and exclusion criteria) from antenatal clinic/ admitted in the in-patient ward under the department of O&G will be recruited

•                In a relatively quiet room, routine USG will be done, fetal movements will be noticed and confirmation will be made that the fetus is not in the sleep mode. In case the foetus is found to be in sleep mode, it would be gently stimulated with external movement.

•                The maternal abdominal wall thickness, liquor volume, fetal position, location of the fetal heart and head (pinna) will be noted down.

•                The VAS stimuli will be produced directly over the abdominal wall overlying the fetal head/ pinna.

•                Comparison will be made before and after administration of VAS with a commercially available battery operated fetal acoustic stimulation device 

•                Three times the VAS will be conducted for 10 seconds each with 60 seconds interval between them to see the response of the fetus.

•                Fetal heart rate variance and Fetal movements – gross body movements, isolated limb movements, breathing movement and startle response including the number and types will be noted

•                Fetal movements, heart rate accelerations from the baseline for next 60 secs will be noted following the VAS.

•                Positive response will be considered if the foetus responses to atleast one of stimulus.

•                The typical foetal response to a loud and sudden sound includes a short latency heart rate (H.R) acceleration averaging 15 beats per minute, usually accompanied by limb movements, change in position and eyeblinks and this typical foetal response will be defined as positive response.

•                In case of absence of a positive response, the test would be repeated the next day for admitted patients/ next antenatal visit for out-patient patients.

•                The qualifications and experience of the obstetrician performing the test will also be noted down.

•                The total time taken for performing the screening tests will be noted down.

•                Following the prenatal screening till the delivery and during the peripartum period, the following points will be noted- Administration of ototoxic drugs to mother or baby, fever with rash in the mother, type of delivery, peripartum events, delayed cry, birth weight, neonatal jaundice, NICU stay, ventilator support requirement for the baby etc.

•                Following birth of the baby screening for hearing via OAE, BERA/ABR and OAE + BERA/ABR (BERA as the gold standard for patients with hearing loss on screening test) bedside will be compared to fetal vibroacoustic stimulation to find accuracy of fetal vibroacoustic stimulation as a prenatal hearing screening tool

•                In case the baby failed the prenatal/ neonatal/ both screening for hearing loss, comprehensive hearing test of the baby will carried out in the form of BERA, ASSR and OAE.

•                Assessment of inter-observer discrepancy (Resident Vs Faculties) and Evaluation of the extra time taken for this test by different observers

•                Maternal physical discomfort/pain during this study, maternal emotional concerns during/ for this test, maternal/ parental acceptance of this test will be evaluated by asking a set of three questions about their experience of the test procedure which are –

•                Would you agree to get tested with VAS for your fetal hearing screening?

·                Yes/ no

·                If no then the reason

●               Was the procedure painful?

 If yes, then the score in VAS

●               Would you consider the retesting with VAS in future just prior to the birth of your child? 
 
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