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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  
Name  Address 
nil  nil 
 
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  
Status 
Not Applicable 
 
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.

 
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