| CTRI Number |
CTRI/2025/08/093311 [Registered on: 20/08/2025] Trial Registered Prospectively |
| Last Modified On: |
13/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Assessing Early Brain Development in One-Year-Old Children with Heart Defects and Healthy Children |
|
Scientific Title of Study
|
Neurodevelopment in Congenital Heart Disease Children at One Year Using Global Scales of Early Development Compared to Age Matched Control-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 |
Dr Deepa Metgud |
| Designation |
HOD and Professor |
| Affiliation |
KAHER Institute of physiotherapy, Belgavi 510010 |
| Address |
Advanced Physiotherapy centre- Room 39, Sagar floor, KLE Dr. Prabhakar Kore Hospital, Nehru Nagar, Belgavi, Karnataka 590010 Belgaum, KARNATAKA 590010
Belgaum KARNATAKA 590010 India |
| Phone |
09845861236 |
| Fax |
|
| Email |
deepametgud@klekipt.edu.in |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Deepa Metgud |
| Designation |
HOD and Professor |
| Affiliation |
KAHEER Institute of physiotherapy, Belgavi 510010 |
| Address |
Advanced Physiotherapy centre- Room 39, Sagar floor, KLE Dr. Prabhakar Kore Hospital, Nehru Nagar, Belgavi, Karnataka 590010 Belgaum, KARNATAKA 590010
Belgaum KARNATAKA 590010 India |
| Phone |
09845861236 |
| Fax |
|
| Email |
deepametgud@klekipt.edu.in |
|
Details of Contact Person Public Query
|
| Name |
Merin Daniel |
| Designation |
PG Student |
| Affiliation |
KAHEER Institute of physiotherapy, Belgavi 510010 |
| Address |
Advanced Physiotherapy centre- Room 39, Sagar floor, KLE Dr. Prabhakar Kore Hospital, Nehru Nagar, Belgavi, Karnataka 590010 Belgaum, KARNATAKA 590010
Belgaum KARNATAKA 590010 India |
| Phone |
07040725337 |
| Fax |
|
| Email |
merindaniel99@gmail.com |
|
|
Source of Monetary or Material Support
|
| KLE Dr. Prabhakar Kore Hospital and Medical Research Centre,Nehru Nagar, Belagavi 590010, Karnataka, India |
|
|
Primary Sponsor
|
| Name |
KAHER Institute of Physiotherapy |
| Address |
KAHER Institute of Physiotherapy, JNMC Campus, Nehru Nagar, Belagavi-590010 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Deepa Metgud |
KAHEER Institute of physiotherapy, Belgavi 510010 |
Advanced
physiotherapy centre,
Room No. 39, Paeditric
Physiotherapy
Department, KLEs Dr.
Prabhakar Kore
Hospital & Medical
Research Centre,
Nehru Nagar, Belagavi,
Karnataka 590010
Belgaum
KARNATAKA Belgaum KARNATAKA |
09845861236
deepametgud@klekipt.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KAHER INSTITUTE OF PHYSIOTHERAPY |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Q209||Congenital malformation of cardiacchambers and connections, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
12.00 Month(s) |
| Age To |
15.00 Month(s) |
| Gender |
Both |
| Details |
Children age 12-15 month diagnosed with congenital heart disease
Healthy children between 12-15 month for control group |
|
| ExclusionCriteria |
| Details |
Preterm birth
Genetic conditions
Neurological disorder
syndrome conditions |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Global Scales for Early Development (GSED) |
BASELINE TO, AT THE START OF THE STUDY ONLY |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="70" Sample Size from India="70"
Final Enrollment numbers achieved (Total)= "70"
Final Enrollment numbers achieved (India)="70" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/10/2025 |
| Date of Study Completion (India) |
20/02/2026 |
| 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
|
This observational study aims to evaluate the neurodevelopment of one-year-old children with congenital heart disease (CHD) using the Global Scales of Early Development (GSED), comparing their outcomes with age-matched healthy controls. CHD is one of the most common congenital disorders globally and in India, with significant survival improvements due to advancements in medical and surgical care. However, children with CHD remain at high risk for neurodevelopmental delays due to factors such as chronic hypoxia, altered cerebral blood flow, perioperative complications, and prolonged hospitalization. The study highlights the importance of early assessment during infancy, a critical period for brain development, to identify potential delays in cognitive, motor, language, and socio-emotional skills. he research will be conducted in a tertiary care hospital and Anganwadi centers, enrolling 70 children aged 12 to 15 months—35 diagnosed with CHD and 35 healthy controls. Using both the caregiver-reported short form and the professionally administered long form of the GSED, the study will generate developmental scores (D-scores) to assess and compare neurodevelopment across multiple domains. The selection will follow specific inclusion and exclusion criteria, and data will be collected through informed consent, demographic recording, and standardized developmental assessments. |