| CTRI Number |
CTRI/2023/10/058762 [Registered on: 17/10/2023] Trial Registered Prospectively |
| Last Modified On: |
17/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Neuro development of children born during COVID 19 in Belagavi city |
|
Scientific Title of Study
|
Neurodevelopmental status of children born during COVID-19 pandemic in Belagavi city: A Cross-Sectional 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 |
Pratiksha kalgutkar |
| Designation |
Post Graduate student |
| Affiliation |
KAHER institute of physiotherapy |
| Address |
Advanced Physiotherapy center, room no 39, sagar floor, KLE Dr prabhakar kore Hospital Belgaum Karnataka 590010
Belgaum
Karnataka
590010
India
Belgaum
KARNATAKA
590010
India |
| Phone |
9969749524 |
| Fax |
|
| Email |
pratikshackalgutkar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vinuta Deshpande |
| Designation |
Assistant Professor |
| Affiliation |
KAHER institute of physiotherapy |
| Address |
Advanced Physiotherapy center, room no 39, sagar floor, KLE Dr prabhakar kore Hospital Belgaum Karnataka 590010
Belgaum
Karnataka
590010
India
Belgaum
KARNATAKA
590010
India |
| Phone |
08754466612 |
| Fax |
|
| Email |
vinuta.gangavatikar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Pratiksha kalgutkar |
| Designation |
Post Graduate student |
| Affiliation |
KAHER institute of physiotherapy |
| Address |
Advanced Physiotherapy center, room no 39, sagar floor, KLE Dr prabhakar kore Hospital Belgaum Karnataka 590010
Belgaum
Karnataka
590010
India
Belgaum
KARNATAKA
590010
India |
| Phone |
9969749524 |
| Fax |
|
| Email |
pratikshackalgutkar@gmail.com |
|
|
Source of Monetary or Material Support
|
| KLE Dr Prabhakar kore hospital and research center, Nehru nagar,belagavi |
|
|
Primary Sponsor
|
| Name |
Pratiksha Kalgutkar |
| Address |
Sagar Floor, Advanced Physiotherapy Centre, Room no 39, KLE
Dr.Prabhakar Kore Hospital and MRC, Belagavi,Karnataka, 590010 |
| Type of Sponsor |
Other [ [self sponsored]] |
|
|
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 |
| DrPratiksha Kalgutkar |
KAHER institute of physiotherapy |
Advanced Physiotherapy center, room no 39, sagar floor, KLE Dr prabhakar kore Hospital Belgaum Karnataka 590010
Belgaum
Karnataka
590010
India
Belgaum
KARNATAKA |
9969749524
pratikshackalgutkar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Research and Ethical Comittee KAHER Institute of Physiotherapy |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Children born during COVID 19 |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
3.00 Year(s) |
| Gender |
Both |
| Details |
Children at 2 years of age
Children with gestational age >37 weeks and birth weight > 2.5 KgChildren born between March 2020 to May 2021
Both genders |
|
| ExclusionCriteria |
| Details |
Children diagnosed with any hearing or visual impairments
None of the children or their mothers were reported positive with COVID-19
No neurological trauma in the infant
not diagnosed with neurological disorder like epilepsy, autism, brain tumors, cerebral palsy
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Bayley Scales of Infant & Toddler Development (BSID 4) |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="48"
Sample Size from India="48"
Final Enrollment numbers achieved (Total)= "48"
Final Enrollment numbers achieved (India)="48" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
26/10/2023 |
| Date of Study Completion (India) |
27/03/2024 |
| Date of First Enrollment (Global) |
26/10/2023 |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
The neurodevelopmental status of the study participants was assessed and delay was found in fine motor, language, socio emotional, communication and adaptive behavior domain on the BSID IV scale |