| CTRI Number |
CTRI/2025/08/093616 [Registered on: 25/08/2025] Trial Registered Prospectively |
| Last Modified On: |
25/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Developmental profile in children with congenital heart diseases |
|
Scientific Title of Study
|
Developmental profile in children with congenital heart diseases |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Tejaswini S Kudachimath |
| Designation |
Physiotherapy post graduate |
| Affiliation |
SDM College of Physiotherapy |
| Address |
SDM college of Medical Sciences and Hospitals SDM University Paediatric physiotherapy Department, 1st floor, old building OPD No 13 SDM College of Physiotherapy SDM University, Sattur Dharwad
Dharwad
KARNATAKA
580009
India |
| Phone |
6361850023 |
| Fax |
|
| Email |
tejaswinisk01@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jyoti S Jeevannavar |
| Designation |
Professor PG guide |
| Affiliation |
SDM College of Physiotherapy |
| Address |
SDM college of Medical Sciences and Hospitals SDM University Paediatric physiotherapy Department, 1st floor, old building OPD No 13 SDM college of physiotherapy SDM University, Sattur Dharwad
Dharwad
KARNATAKA
580009
India |
| Phone |
9972189767 |
| Fax |
|
| Email |
Drjyotisj@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Tejaswini S Kudachimath |
| Designation |
Physiotherapy post graduate |
| Affiliation |
SDM College of Physiotherapy |
| Address |
SDM college of Medical Sciences and Hospitals SDM University Paediatric physiotherapy Department, 1st floor, old building OPD No 13 SDM College of Physiotherapy SDM University, Sattur Dharwad
Dharwad
KARNATAKA
580009
India |
| Phone |
6361850023 |
| Fax |
|
| Email |
tejaswinisk01@gmail.com |
|
|
Source of Monetary or Material Support
|
| SDM hospital, Paediatric Physiotherapy OPD No 13 Sattur
Dharward
Karnataka |
|
|
Primary Sponsor
|
| Name |
Tejaswini S Kudachimath |
| Address |
SDM college of Physiotherapy SDM University, Sattur Dharwad 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 |
| Tejaswini S Kudachimath |
SDM Hospital |
Paediatric Physiotherapy OPD No 13
Sattur
Dharwad
KARNATAKA |
06361850023
tejaswinisk01@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC-SDM college of medical Sciences and Hospitals |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Q210||Ventricular septal defect, (2) ICD-10 Condition: Q211||Atrial septal defect, (3) ICD-10 Condition: Q213||Tetralogy of Fallot, (4) ICD-10 Condition: Q212||Atrioventricular septal defect, (5) ICD-10 Condition: Q218||Other congenital malformations ofcardiac septa, (6) ICD-10 Condition: Q208||Other congenital malformations ofcardiac chambers and connections, (7) ICD-10 Condition: Q214||Aortopulmonary septal defect, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
1. Children of either gender.
2. Children with the age group of 2-10
years.
3. Children diagnosed with CHD by a
medical practitioner |
|
| ExclusionCriteria |
| Details |
1. Children with genetic syndromes and
neurological diseases.
2. Children of parents unable to provide
the history of developmental milestone. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| history of developmental milestones |
one time |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
10/09/2025 |
| 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 focuses on assessing developmental patterns in children aged 2 to10 years diagnosed with congenital heart disease CHD affecting about 1 in 100 live births worldwide is one of the most common congenital abnormalities but its prevalence and developmental profile in the Indian population remain underexplored Common defects include ventricular septal defects, atrial septal defects transposition of great vessels patent ductus arteriosus and tetralogy of Fallot which are classified as cyanotic or acyanotic While the exact cause is often unknown contributing factors may include genetic syndromes single-gene defects and environmental influences such as maternal diabetes infections and drug exposure Advances in medical and surgical care have improved survival yet up to 75 percentage of these children experience developmental delays in motor cognitive and socio-emotional domains due to impaired cerebral oxygenation surgical factors and other associated risks This cross-sectional observational study will recruit 40 children through purposive sampling using parent interviews medical record reviews and a detailed developmental milestone checklist Data will be analyzed with descriptive statistics normality testing and Pearsons correlation The studys novelty lies in its focus on both gross and fine motor trajectories while considering demographic and medical history factors in the Indian context Expected outcomes include identifying prevalence and patterns of delay facilitating early screening guiding parental counseling and designing targeted interventions to improve long-term outcomes Ethical approval has been obtained and participation is voluntary confidential and involves minimal risk |