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CTRI Number  CTRI/2023/07/055364 [Registered on: 19/07/2023] Trial Registered Prospectively
Last Modified On: 17/07/2023
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   longitudinal study 
Study Design  Other 
Public Title of Study   Comparison of growth in pre & 3 months post surgery of heart disease in children under 5 years of age  
Scientific Title of Study   Early growth trends of children under 5 years of age with congenital heart disease who have undergone corrective surgery - a longitudinal study  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Hershavardhini K 
Designation  MD PEDIATRICS 
Affiliation  Jawaharlal Nehru Medical college 
Address  Department of Pediatrics, Jawaharlal Nehru Medical college, Nehru nagar, KLE hospital road, Belgaum

Belgaum
KARNATAKA
590010
India 
Phone  8056764999  
Fax    
Email  harini.rohit@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Veeresh Manvi 
Designation  Professor, Pediatric cardiology 
Affiliation  Jawaharlal Nehru Medical college 
Address  Department of Pediatrics, Jawaharlal Nehru Medical college, Nehru nagar, KLE hospital road, Belgaum

Belgaum
KARNATAKA
590010
India 
Phone  9164000009  
Fax    
Email  manviveeresh@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Hershavardhini K 
Designation  MD PEDIATRICS 
Affiliation  Jawaharlal Nehru Medical college 
Address  Department of Pediatrics, Jawaharlal Nehru Medical college, Nehru nagar, KLE hospital road, Belgaum

Belgaum
KARNATAKA
590010
India 
Phone  8056764999  
Fax    
Email  harini.rohit@gmail.com  
 
Source of Monetary or Material Support  
KLEs DR Prabhakar Kore Hospital, Jawaharlal Nehru Medical College, KLE University, Belgaum 
 
Primary Sponsor  
Name  Jawaharlal Nehru Medical College KLE University Belagavi 
Address  Department of Pediatrics, Jawaharlal Nehru Medical college, Nehru nagar, KLE Hospital road, Belgaum, Karnataka 590010 
Type of Sponsor  Private 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 Hershavardhini K  KLEs Dr Prabhakar Kore hospital  Department of Paediatrics,Jawaharlal Nehru MEdical college,Belagavi
Belgaum
KARNATAKA 
8056764999

harini.rohit@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Jawaharlal Nehru Institutional Ethical committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
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: Q250||Patent ductus arteriosus, (5) ICD-10 Condition: Q258||Other congenital malformations ofother great arteries, (6) ICD-10 Condition: Q212||Atrioventricular septal defect,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Nil  Nil 
 
Inclusion Criteria  
Age From  1.00 Day(s)
Age To  5.00 Year(s)
Gender  Both 
Details  1.Children under 5 yrs of age with Congenital heart disease fit for corrective surgery
2.Children under 5 yrs of age with failure to thrive with heart disease  
 
ExclusionCriteria 
Details  1.Children under 5 years of age undergoing palliative surgery.
2.Children under 5 years of age with congenital heart disease with with other co morbidities like proven chromosomal abnormalities such as downs syndrome, diagnosed with metabolic disorders like galactosemia and hypothyroidism, congenital anomalies that restrict oral feeding like cleft palate and cleft lip.
3.Children whose parents donot agree for followup.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To evaluate the early growth trends of children with congenital heart disease who have undergone corrective surgery under 5 years of age.
 
The study will be completed in the span of 1 year 
 
Secondary Outcome  
Outcome  TimePoints 
To identify factors affecting growth in children with Congenital heart disease & analyse the short term effects of corrective surgery.
 
The study will be completed in 1 year 
 
Target Sample Size   Total Sample Size="102"
Sample Size from India="102" 
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)   01/08/2023 
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 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 - NO
Brief Summary   Congenital heart disease is the most common congenital anomaly found in newborn and nearly 9 to 11 in 1000 newborns are born with cardiac anom- alies in India.[1].Atrial septal defect, ventricular septal defect, patent ductus arteriosus, are the most common congenital heart diseases.[2]

Malnutrition is a common cause of morbidity in such children[3-8]. The extent to which the preoperative nutritional status affects the post op growth is un- known. There may be various factors such as ethnicity, socioeconomic sta- tus, nutritional practices, other cultural and environmental factors that may affect the nutritional status of the child with congenital heart disease[9].

There are various studies showing that corrective surgery shows a significant improvement in growth parameters within 3 months of post surgery{9-11]. However, studies have also shown that postoperative catch-up growth was less pronounced or even absent in 15%-50% of patients depending on the study[8,13]. The factors affecting growth in a child with congenital heart dis- ease may vary worldwide and hence there is a need to assess growth in these children in local conditions. The understanding and prevention of the effect of CHD on patients’ growth and development status in developing countries still needs improvement[11].

This study Is aimed at analysing the early growth trends of children pre and post operatively and factors affecting growth in this region of the country. This study also emphasises the importance of nutritional and growth as- sessment preoperatively so as to predict the early catchup growth post sur- gical correction.
 
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