| CTRI Number |
CTRI/2024/06/069685 [Registered on: 28/06/2024] Trial Registered Prospectively |
| Last Modified On: |
20/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To study the prevalence of hearing loss in sick newborns at government hospital Kalaburagi using otoacoustic emission test |
|
Scientific Title of Study
|
To estimate the prevalence of hearing impairment among at risk neonates in a Government tertiary health care centre Kalaburagi |
| 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 Vijaylakshmi |
| Designation |
Resident in Department of Pediatrics |
| Affiliation |
Gulbarga Institute Of Medical Sciences, Kalaburagi |
| Address |
Post Graduate, Department of Pediatrics , Gulbarga Institute of Medical Sciences, Veeresh Nagar cross, Sedam road, behind MRMC , Kalaburagi 585101
Gulbarga
KARNATAKA
585101
India |
| Phone |
9632009236 |
| Fax |
|
| Email |
vijjunayak446@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sandeep V H |
| Designation |
Professor in Department of Pediatrics |
| Affiliation |
Gulbarga Institute Of Medical Sciences, Kalaburagi |
| Address |
Department of Pediatrics, Gulbarga Institute of Medical Sciences, Veeresh Nagar cross, Sedam road, behind MRMC , Kalaburagi 585101
Gulbarga
KARNATAKA
585101
India |
| Phone |
9741094111 |
| Fax |
|
| Email |
vhsandeep@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sachin S Hatti |
| Designation |
Assistant Professor in Department of Pediatrics DEPARTMENT OF PAEDIATRICS |
| Affiliation |
Gulbarga Institute Of Medical Sciences, Kalaburagi |
| Address |
Department of Pediatrics, Gulbarga Institute of Medical Sciences, Veeresh Nagar cross, Sedam road, behind MRMC , Kalaburagi 585101
Gulbarga
KARNATAKA
585101
India |
| Phone |
9481002893 |
| Fax |
|
| Email |
sachinhatti@gmail.com |
|
|
Source of Monetary or Material Support
|
| Gulbarga Institute of Medical Sciences, Veeresh Nagar cross, Sedam road, behind MRMC , Kalaburagi, Karnataka, India 585101 |
|
|
Primary Sponsor
|
| Name |
Gulbarga Institute of Medical Sciences |
| Address |
GIMS Hospital, Department of Pediatrics, Gulbarga Institute of Medical Sciences, Veeresh Nagar cross, Sedam road, behind MRMC , Kalaburagi,Karnataka 585101 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Vijaylakshmi |
Gulbarga Institute of Medical Sciences |
Neonatal intensive care unit/ Pediatric intensive care unit block, Department of Pediatrics , Gulbarga Institute of Medical Sciences, Veeresh Nagar cross, Sedam road, behind MRMC, Kalaburagi 585101
Gulbarga
KARNATAKA |
9632009236
vijjunayak446@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE GULBARGA INSITITUTE OF MEDICAL SCIENCES KALABURAGI |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: P09||Abnormal findings on neonatal screening, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
3.00 Month(s) |
| Gender |
Both |
| Details |
1. Neonates having middle ear pathology, meatal atresia
2. Any fatal event before completion of study
3. Refusal by parents
|
|
| ExclusionCriteria |
| Details |
1.Neonates having middle ear pathology, meatal atresia
2.Any fatal event before completion of study
3.Refusal by parents
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1.To estimate prevalence of hearing impairment among “at riskâ€neonates admitted in NICU |
1.To estimate prevalence of hearing impairment among “at riskâ€neonates admitted in NICU using OAE screening and failed neonates will be subjected OAE at 1 month if failed second screening by OAE at 3 months baby will be subjected to BERA if failed again then subjected to BERA at 6 months.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 2.To devise a new screening protocol for “at risk †hearing impaired babies. |
Early identification of hearing impairment by BERA by 3 to 6 months
To have hearing aids by 1 year
To educate & conduct national programmes at anganwadi & subcenters level
Follow up of babies through Telecommunication |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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)
|
02/07/2024 |
| 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="6"
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
|
The first three years
of life are most important for language and speech development .consequently
,for many infants and young children
with unidentified hearing impairment much
of the crucial period for language and speech development may be lost .Moderate to profound
hearing loss in early infancy has been
shown to be associated with impaired
language development ,as auditory
stimuli during this period are critical to development of speech and language
skills. This causes effect on reading abilities ,decreased
scholastic performances. Hence to generate the local data at regional level. |