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CTRI Number  CTRI/2024/03/064119 [Registered on: 14/03/2024] Trial Registered Prospectively
Last Modified On: 13/03/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   Growth and Development in Children with Cardiac Intervention before the age of 5 
Scientific Title of Study   Growth and Development in Children who underwent Cardiac Intervention before the age of 5 
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 Pushpa G Kini 
Designation  Professor 
Affiliation  KMC, Manipal 
Address  Department of Paediatrics, Woman and Children Block, Kasturba Hospital, KMC, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9845289801  
Fax    
Email  pushpa.kini@manipal.edu  
 
Details of Contact Person
Scientific Query  
Name  Dr Pushpa G Kini 
Designation  Professor 
Affiliation  KMC, Manipal 
Address  Department of Paediatrics, Woman and Children Block, Kasturba Hospital, KMC, Manipal


KARNATAKA
576104
India 
Phone  9845289801  
Fax    
Email  pushpa.kini@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Dr Krishanu Sabyasachi Mukhopadhyay 
Designation  Junior Resident 
Affiliation  KMC, Manipal 
Address  Department of Paediatrics, Woman and Children Block, Kasturba Hospital, KMC, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9901802819  
Fax    
Email  ksmukhopadhyay007@gmail.com  
 
Source of Monetary or Material Support  
Department of Paediatrics, Woman and Children Block, Kasturba Hospital, KMC, Manipal 
 
Primary Sponsor  
Name  Dr Krishanu Sabyasachi Mukhopadhyay 
Address  Department of Paediatrics, KMC, Manipal 
Type of Sponsor  Other [Self] 
 
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 Pushpa G Kini  Kasturba Hospital, Manipal  Department of Paediatrics, Woman and Children Block, Kasturba Hospital, KMC, Manipal
Udupi
KARNATAKA 		 9845289801

pushpa.kini@manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee-2 (Student Research)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: Q20-Q28||Congenital malformations of the circulatory system,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  nil  nil 
 
Inclusion Criteria  
Age From  1.00 Year(s)
Age To  10.00 Year(s)
Gender  Both 
Details  Patients who underwent corrective Cardiac Surgery or Catheter based Intervention for Congenital Heart Disease before the age of 5
At the Time of enrollment, at least 1 year has elapsed since the last corrective procedure was performed on the child.
 
 
ExclusionCriteria 
Details  History of Birth Asphyxia or HIE.
History of stormy neonatal period with exclusive focus on those who suffered from Severe Intracranial Hemorrhage Meningitis Neonatal Seizures Sepsis TORCH infection and Neonatal Hyperbilirubinemia requiring Exchange Transfusion
Extreme Prematurity at birth less than 28 weeks of gestation
Syndromic etiology of Congenital Heart Disease.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Neurodevelopmental assessment based on the developmental quotient and categorized into
Normal Neurodevelopmentally- DQ greater than 85
Mild Neurodevelopmental Delay- DQ between 71 to 84
Severe Neurodevelopmental Delay DQ less than 70
Final Growth assessment will be based on the Z score for weight age-
Normal Growth
Mild Growth failure -1SD to -2SD
Moderate Growth Failure -2SD to -3SD.
Severe Growth Failure less than -3SD

 		 At Baseline
 
 
Secondary Outcome  
Outcome  TimePoints 
Positive or negative correlation of Growth Failure & Neurodevelopmental delay with other factors present in the study population.  At Baseline 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
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)   23/03/2024 
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="5"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [ksmukhopadhyay007@gmail.com].

  6. For how long will this data be available start date provided 01-07-2025 and end date provided 31-03-2027?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary   The study is a prospective observational cross sectional study to growth and neurodevelopmental outcome in children with congenital heart disease who underwent cardiac surgery or catherter based intervention before the age of 5. The study will be conducted in the Department of Paediatrics at Kasturba Medical College, Manipal. The primary outcome to measure to the neurodevelopmental outcome based on the developmental quotient of the child and growth will be assessed upon the Z-Score for weight for age and positive and negative correlation of Growth Failure and Neurodevelopmental delay will be compared with other factors present in the study population.
 
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