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CTRI Number  CTRI/2024/10/074557 [Registered on: 01/10/2024] Trial Registered Prospectively
Last Modified On: 27/09/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Screening 
Study Design  Single Arm Study 
Public Title of Study   A study to evaluate the screening program for hearing in newborn babies and to analyse the results obtained in the program and to check for aspects which can be improved in this program so that it can be applied universally 
Scientific Title of Study   Ambispective study to assess Universal Newborn Hearing Screening Program 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Narendhiran S 
Designation  Junior Resident (Academic) 
Affiliation  AIIMS New Delhi 
Address  Department of ENT and Head-Neck surgery, Room No.4057,4th floor teaching block, Academic section, AIIMS, New Delhi

South
DELHI
110029
India 
Phone  9952534226  
Fax    
Email  narensathyamoorthy@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Prof Kapil Sikka 
Designation  Professor 
Affiliation  AIIMS New Delhi 
Address  Department of ENT and Head-Neck surgery, Room No.4057,4th floor teaching block, Academic section, AIIMS, New Delhi

South
DELHI
110029
India 
Phone  9810423088  
Fax    
Email  kapil_sikka@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr Narendhiran S 
Designation  Junior Resident (Academic) 
Affiliation  AIIMS New Delhi 
Address  Department of ENT and Head-Neck surgery, Room No.4057,4th floor teaching block, Academic section, AIIMS, New Delhi

South
DELHI
110029
India 
Phone  9952534226  
Fax    
Email  narensathyamoorthy@gmail.com  
 
Source of Monetary or Material Support  
Department of ENT and Head-Neck surgery, Room No.4057,4th floor teaching block, Academic section, AIIMS, New Delhi -110029 
 
Primary Sponsor  
Name  AIIMS New Delhi 
Address  AIIMS Delhi, Ansari Nagar East, New Delhi 110029 
Type of Sponsor  Research institution and hospital 
 
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 NARENDHIRAN S  AIIMS New Delhi   3A ward, 3B ward, 3C ward, NICU, Recovery room, Post Natal Care room- Mother and Child Block and Old/New Private ward AIIMS, New Delhi - 110029
South
DELHI 		 9952534226

narensathyamoorthy@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTE ETHICS COMMITTEE FOR POST GRADUATE RESEARCH  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: H905||Unspecified sensorineural hearingloss,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Hearing Screening  All newborn babies born in AIIMS, New Delhi irrespective of whether admitted in NICU or NonNICU (Neonatology ward, Kangaroo Mother care ward) undergo Universal Newborn Hearing Screening Program and their data will be considered for analysis of coverage, pass and refer percentage, drop out , follow up of the screening program. 270 subjects [irrespective of low or high risk(Non-NICU or NICU) ] will be screened for OAE by a trained audiologist and by untrained professionals (nursing staff - untrained in in performing audiological tests) and outcomes will be compared. Subjects who get ‘REFER’ following the above screening will further undergo OAE & AABR by a trained audiologist (second screening).Low risk subjects who get Referred in second screening will undergo diagnostic ABR (Referred Subjects will be consecutively assessed for both OAEs and AABR irrespective of high/low risk and estimates of ANSD probability will be assessed).270 subjects [includes both NonNICU (low risk) and NICU (high risk) subjects] will be screened for OAE in the bedside and parallelly in an isolated, closed room and the outcomes will be compared. (However, if a child in the NICU cannot be shifted to an isolated room, he/she will not be considered for this comparison).All ANSD suspects shall undergo detailed evaluation by audiologist for confirmation (Cochlear microphonics and follow up).913 low risk subjects (Non -NICU) will also be screened with OAE and AABR for Auditory Neuropathy Spectrum Disorder. (NICU – high risk newborns will anyway be screened for ANSD as they are highly prone for ANSD).All patients who have failed to follow up will be contacted telephonically to assess the reason for failure to follow up. The above said screening test will be performed only once. There is no specific duration through which this test will be continuously done. 
Comparator Agent  N/A  N/A 
 
Inclusion Criteria  
Age From  1.00 Day(s)
Age To  1.00 Year(s)
Gender  Both 
Details  All newborn children in the
neonatology ward, NICU 
 
ExclusionCriteria 
Details  Children whose parents are not
willing to participate in the study 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
To assess differences in outcome
of OAE with different testing
environment (ward/NICU/
isolated room).To assess differences in outcome
of OAE when done by trained
(audiologist) and untrained
professionals (nursing staff).To enumerate the difficulties
faced during screening and
describe best practice protocols
on who and where on UNHS.To assess the incidence of
Auditory Neuropathy Spectrum
Disorder (ANSD) in newborns.To assess the reasons for loss to
follow up 		 Within 1 month of child birth 
 
Secondary Outcome  
Outcome  TimePoints 
To assess the coverage, pass
and refer percentage, drop
out , follow up percentage
of Universal Newborn
Hearing Screening Program
at a Quaternary hospital
setup (AIIMS, New Delhi) 		 Within 1 month of child birth, at 3 months & at 6 months 
 
Target Sample Size   Total Sample Size="913"
Sample Size from India="913" 
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   N/A 
Date of First Enrollment (India)   08/10/2024 
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="0"
Months="8"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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 - NO
Brief Summary   Though there are OAE and AABR screening done in many hospitals in India, there is a paucity of research in analysing the outcomes of the screening program. There has been no dedicated research on influencing factors of ‘who is doing the screening and where is it being done’ with respect to the newborn hearing screening test. As recommended by Joint Committee on Infant Hearing it is important to document and analyse the coverage, drop out percentage, follow up percentage of any newborn hearing screening program as they will serve as the quality indicators for the program. Also analysing the existing program will help in further corrections as well as serve as a guide for the wide spread implementation of the program throughout the country.  
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