| CTRI Number |
CTRI/2024/07/071284 [Registered on: 25/07/2024] Trial Registered Prospectively |
| Last Modified On: |
20/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Neurodevelopment of children born with Preterm and Low Birth Weight at 3 years of age in Belagavi City |
|
Scientific Title of Study
|
Neurodevelopmental Outcomes of Preterm and Low Birth Weight Infants at 3 years in Belagavi City – An Observational 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 |
Sinchana L |
| 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 |
| Phone |
8277499885 |
| Fax |
|
| Email |
ssiinch.mar22@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 |
| Phone |
8754466612 |
| Fax |
|
| Email |
vinuta.gangavatikar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sinchana L |
| 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 |
| Phone |
8277499885 |
| Fax |
|
| Email |
ssiinch.mar22@gmail.com |
|
|
Source of Monetary or Material Support
|
| KLE Dr. Prabhakar Kore Hospital and Research Center, Nehru Nagar, Belagavi, Karnataka, India - 590010. |
|
|
Primary Sponsor
|
| Name |
Sinchana L |
| Address |
Advanced Physiotherapy center, room no 39, sagar floor, KLE Dr
prabhakar kore Hospital Belgaum Karnataka 590010 Belgaum
Karnataka 590010 India
Belgaum |
| 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 |
| Dr Sinchana L |
KAHER Institute of Physiotherapy |
Advanced
Physiotherapy Center,
Room No: 39, Sagar floor,
KLE Dr Prabhakar Kore
Hospital Belgaum,
Karnataka 590010
Belgaum
KARNATAKA |
8277499885
ssiinch.mar22@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 |
3 year old children born preterm and low birth weight |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
3.11 Year(s) |
| Gender |
Both |
| Details |
Male and female children at 3 years of age .
Preterm less than 37 weeks of gestation and low birth weight infants who visited the high-risk baby clinic/maternal care unit at a hospital, Belagavi presently residing in Belagavi City.
Parent of the child willing to participate in the study and to come to tertiary care hospital, Belagavi.
|
|
| ExclusionCriteria |
| Details |
Children who are critically ill or with genetic disorders, congenital anomalies, metabolic diseases.
Children with known neuromotor disabilities.
Children with a history of surgery in the past 6 months or planned for surgeries in next 3 months.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
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="49"
Sample Size from India="49"
Final Enrollment numbers achieved (Total)= "49"
Final Enrollment numbers achieved (India)="49" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/08/2024 |
| Date of Study Completion (India) |
30/03/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
In India, research shows that premature and low birth weight infants may have developmental issues. Monitoring their development until preschool age is crucial. A widely used tool is available to assess cognitive, motor, language, and social-emotional development, aiding in early identification. The purpose of this study is to understand their long-term developmental needs using BSID-IV in India. |