| CTRI Number |
CTRI/2024/05/067820 [Registered on: 22/05/2024] Trial Registered Prospectively |
| Last Modified On: |
22/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
Hearing loss in early born babies and their brain development |
|
Scientific Title of Study
|
Hearing assessment in preterms born lessthan or equal to 34 weeks and its correlation with neurodevelopmental outcome at corrected 4 months of age-An observational longitudnal study |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mamidala Vyshnavi Netha |
| Designation |
Post graduate |
| Affiliation |
Jawaharlal nehru medical college |
| Address |
department of paediatrics,jawaharlal nehru medical college, belgaum
Belgaum
KARNATAKA
590001
India |
| Phone |
8074059419 |
| Fax |
|
| Email |
mvyshnavinetha@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrManisha Bhandankar |
| Designation |
proffessor |
| Affiliation |
Jawaharlal nehru medical college |
| Address |
Department of Neonatology
Belgaum
KARNATAKA
590001
India |
| Phone |
9164205166 |
| Fax |
|
| Email |
manisha.bhandankar1970@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrManisha Bhandankar |
| Designation |
Proffessor |
| Affiliation |
jawaharlal nehru medical college |
| Address |
Department of Neonatology
Belgaum
KARNATAKA
590001
India |
| Phone |
9164205166 |
| Fax |
|
| Email |
manisha.bhandankar1970@gmail.com |
|
|
Source of Monetary or Material Support
|
| KAHERs Dr.Prabhakar kore hospital and medical institute research,belgaum , karnataka,590001 institute |
|
|
Primary Sponsor
|
| Name |
Mamidala Vyshnavi Netha |
| Address |
Department of pediatrics,JNMC ,belgaum,590001 , karnataka |
| Type of Sponsor |
Other [self] |
|
|
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 Vyshnavi Netha |
KAHERs Dr.Prabhakar kore hospital and medical research institute |
Department of paediatrics,jnmc ,Belgaum,590001
Belgaum
KARNATAKA |
8074059419
mvyshnavinetha@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JNMC institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Hearing loss and neurological delay |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
4.00 Month(s) |
| Gender |
Both |
| Details |
Inborn and outborn neonates lessthan or equal to 34weekswho get discharged from NICU of KLEH followed up at HRB clinic for till 4 months .Those neonaes for whom informed consent has been obtained from parents or guardian |
|
| ExclusionCriteria |
| Details |
Preterms with craniofacial Anomalies. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Hearing status in preterm infants born lessthan or equal to 34 weeks |
4months of corrected gestational age |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess neurodevelopmental outcome in preterms born lessthan or equal to 34weeks in correlation to hearing status |
At corrected 4 months of age |
|
|
Target Sample Size
|
Total Sample Size="66"
Sample Size from India="66"
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)
|
04/06/2024 |
| 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="0"
Days="0" |
|
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 - NO
|
|
Brief Summary
|
This study aims to assess hearing status in preterm infants born lessthan or equal to 34 weeks at the time of discharge by OAE and at 40 weeks by OAE and diagnostic ABR and by diagnostic ABR at corrected 4 months of age mif hearing loss present at 40 weeks and then to correlate the neurodevelopmental outcome of the babies at corrected 4 months of age |