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CTRI Number  CTRI/2021/05/033714 [Registered on: 21/05/2021] Trial Registered Prospectively
Last Modified On: 18/02/2023
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Retrospective 
Study Design  Other 
Public Title of Study   Which heart diseases cause children to die? 
Scientific Title of Study   Clinicopathological analysis of heart disease in pediatric age group 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sunil Karande 
Designation  Professor of Pediatrics 
Affiliation  Seth GS Medical College and KEM Hospital 
Address  Department of Pediatrics, Seth GS Medical College and KEM Hospital
Department of Pediatrics, Seth GS Medical College and KEM Hospital
Mumbai
MAHARASHTRA
400012
India 
Phone  9322934309  
Fax    
Email  sunilkarande@kem.edu  
 
Details of Contact Person
Scientific Query
 
Name  Sunil Karande 
Designation  Professor of Pediatrics 
Affiliation  Seth GS Medical College and KEM Hospital 
Address  Department of Pediatrics, Seth GS Medical College and KEM Hospital
Department of Pediatrics, Seth GS Medical College and KEM Hospital
Mumbai
MAHARASHTRA
400012
India 
Phone  9322934309  
Fax    
Email  sunilkarande@kem.edu  
 
Details of Contact Person
Public Query
 
Name  Trusha More 
Designation  Junior Resident 
Affiliation  Seth GS Medical College and KEM Hospital 
Address  Department of Pediatrics, Seth GS Medical College and KEM Hospital
Department of Pediatrics, Seth GS Medical College and KEM Hospital
Mumbai
MAHARASHTRA
400012
India 
Phone  9920889841  
Fax    
Email  trushamore@yahoo.co.in  
 
Source of Monetary or Material Support  
Seth GS Medical College and KEM Hospital 
 
Primary Sponsor  
Name  KEM Hospital 
Address  Department of Pediatrics Seth GS Medical College and KEM Hospital Mumbai 400012 
Type of Sponsor  Government medical college 
 
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 Sunil Karande  Department of Pediatrics  Department of Pediatrics, Seth GS Medical College and KEM Hospital
Mumbai
MAHARASHTRA 
9322934309

sunilkarande@kem.edu 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee III  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I00-I99||Diseases of the circulatory system,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Retrospective analysis  Retrospective clinicopathological analysis of heart disease in pediatric age group will be done from clinical case records and autopsy records 
 
Inclusion Criteria  
Age From  1.00 Month(s)
Age To  12.00 Year(s)
Gender  Both 
Details  All children with evidence of heart disease on autopsy  
 
ExclusionCriteria 
Details  No exclusion criteria 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To study the clinical profile etiology and pattern of fatal heart diseases in children in whom autopsy was done in a tertiary care hospital,
We also aim to analyze the level of concordance between the ante mortem clinical diagnoses and post mortem autopsy diagnoses in these children
 
18 months after CTRI registration 
 
Secondary Outcome  
Outcome  TimePoints 
To identify red flags or risk factors for mortality in children having heart disease  18 months after CTRI registration 
 
Target Sample Size   Total Sample Size="110"
Sample Size from India="110" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="121" 
Phase of Trial   N/A 
Date of First Enrollment (India)   20/06/2021 
Date of Study Completion (India) 31/10/2022 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  
After the study is completed it will be published in a scientific journal 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary
Modification(s)  

 Heart diseases are important cause of childhood morbidity and mortality,

Heart disease in children can be congenital or acquired,

Congenital heart diseases are group of heart diseases present since birth,

They are the most common form of birth defects and are the leading cause of birth defect related deaths,

Congenital heart diseases are classified into cyanotic and acyanotic heart diseases,

Acyanotic heart diseases are more common than cyanotic heart disease,

There is left to right shunt in acyanotic heart disease causing right heart hypertrophy and pulmonary hypertension,

In cyanotic heart disease there is right to left shunt of the blood,

This leads to deoxygenated blood entering systemic circulation causing hypoxemia and cyanosis,

Acquired heart diseases are illnesses that occur after birth,

They are a heterogenous group of disorders that arise from damage to the heart and blood vessels by a variety of causes including ischemic hypoxic metabolic nutritional inflammatory and infectious processes,

Common acquired heart disease includes rheumatic heart disease myocarditis and pericardial diseases,

Others include Kawasaki disease and cardiomyopathies,

Heart diseases may be symptomatic or asymptomatic,

Often when heart diseases are asymptomatic they may go undiagnosed or there is delay in diagnosis, This results in grave consequences,

Symptomatic children may show cardiac specific or non-specific symptoms,

Cardiac specific symptoms include cyanosis, breathlessness suck rest suck cycle chest pain and palpitations,

Non specific symptoms include poor weight gain failure to thrive and diaphoresis,

Certain acquired heart diseases may show systemic involvement like fever with rash in Kawasaki disease or migratory polyarthritis in rheumatic heart disease,

With time, there has been a lot of advancement in medical research and technology,

 There has been development in the level of cardiac care provided to pediatric population,

However still gross disparity exists in terms of equitable distribution of available resources and their utility,

 Furthermore data collected regarding childhood heart disease in low and middle income countries is often poor underestimating the disease burden,

Many of the times signs and symptoms like poor growth or lethargy may be the initial presenting complaint,

Hence the underlying actual cause can get misdiagnosed,

 This has led to significant consequences like mortality in pediatric population,

It is well known that autopsy has been a great tool in retrospectively assessing the accuracy of clinical diagnosis

Although there has been significant decline in the number of autopsies over the years autopsy remains an important parameter in retrospectively assessing an undiagnosed or misdiagnosed illness,

The aim of this study is to document the clinical profile etiology and pattern of fatal heart diseases in children in whom autopsy was done in a tertiary care hospital,

 We also aim to analyze the level of concordance between the ante mortem clinical diagnoses and post mortem autopsy diagnoses in these children and identify red flags or risk factors for mortality in children having heart disease

 
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