FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/06/069260 [Registered on: 20/06/2024] Trial Registered Prospectively
Last Modified On: 19/06/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   A Study on the Relationship Between Body Measurements and Heart Size in Healthy Rural Children in Central India 
Scientific Title of Study   Correlation of Anthropometry with Left Ventricular Mass in Normal Rural Children 
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 Astha Khurana  
Designation  junior resident 
Affiliation  Datta Meghe Institute of Higher Education and Research 
Address  Datta Meghe Institute of Higher Education and Research, Department of Pediatrics, JNMC, Sawangi, Wardha

Wardha
MAHARASHTRA
442107
India 
Phone  9511765896  
Fax    
Email  asthakhurana1997@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Amar Taksande 
Designation  Professor and Head of Department 
Affiliation  Department of Pediatrics, Datta Meghe Institute of Higher Education and Research 
Address  Department of Pediatrics, Jawaharlal Nehru Medical College, Datta Meghe Institute of Higher Education and Research, Sawangi (Meghe), Wardha

Wardha
MAHARASHTRA
442001
India 
Phone  9822369233  
Fax    
Email  amar.taksande@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Astha Khurana  
Designation  junior resident 
Affiliation  Datta Meghe Institute of Higher Education and Research 
Address  Datta Meghe Institute of Higher Education and Research, Department of Pediatrics, JNMC, Sawangi, Wardha

Wardha
MAHARASHTRA
442107
India 
Phone  9511765896  
Fax    
Email  asthakhurana1997@gmail.com  
 
Source of Monetary or Material Support  
Datta Meghe Institute of Higher Education and Research, Department of Pediatrics, JNMC, Sawangi, Wardha 
 
Primary Sponsor  
Name  Datta Meghe Institute of Higher Education and Research 
Address  Department of Pediatrics, Jawaharlal Nehru Medical College, Datta Meghe Institute of Higher Education and Research, Sawangi (Meghe), Wardha 
Type of Sponsor  Other [Datta Meghe Institute of Higher Education and Research] 
 
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 Astha Khurana  Datta Meghe Institute of Higher Education and Research  Department of Pediatrics, Jawaharlal Nehru Medical College, Datta Meghe Institute of Higher Education and Research, Sawangi (Meghe), Wardha
Wardha
MAHARASHTRA 
9511765896

asthakhurana1997@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
DMIHER Institutional Commttee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy Human Volunteers 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  5.00 Year(s)
Age To  15.00 Year(s)
Gender  Both 
Details  Normal healthy rural children aged 5 to 15 years. 
 
ExclusionCriteria 
Details  Child with congenital malformation
Syndromic child
Severe Acute Malnutrition
Any comorbidities 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To find out correlation between anthropometry and left ventricle mass in normal healthy rural children  At baseline 
 
Secondary Outcome  
Outcome  TimePoints 
To investigate sex differences with left ventricle mass   At baseline 
To find out correlation between blood pressure & left ventricular mass  At baseline 
 
Target Sample Size   Total Sample Size="29"
Sample Size from India="29" 
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)   30/06/2024 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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 - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol

  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 - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response (Others) -  by email id

  6. For how long will this data be available start date provided 19-01-2024 and end date provided 19-01-2029?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

After obtaining the informed consent from the parents/guardians children will be included in the study. All normal rural children who come under school health checkup at AVBRH Sawangi, Meghe, Wardha will be included. The design of this study will be a descriptive, cross sectional study. All children will beselected as per inclusion criteria and will be subjected to echocardiography. The demographic data, age and gender of the child will be assessed. According to the detailed history anddiagnosis, all children will be subjected to physical and routine lab investigations. Subjects will be included if they do not have cardiac disease or a history of heart involvement due to infections, neuromuscular or metabolic disorders. The age (in months), weight (Wt) in kilograms (Kg), and the height (Ht) in centimeters (cm) will be obtained. The body surface area (BSA) in square meters (m2 )will be calculated by using the DuBois & DuBois (1916) formula as the following equation: BSA (m2 ) = (0.0001) (71.84) (Wt0.425) (Ht0.725)

 

Transthoracic echocardiographic examination will be performed with the child lying supine or in the left lateral semirecumbent position. No sedation will be used during echocardiography. Twodimensional and M-mode echocardiographic studies will be carried out by a single pediatric cardiologist using a commercially available machine (GE Echocardiography Versana). The two dimensional image will be used to obtain the optimum position and angulation of the M-mode line. Standard parasternal, apical, subcostal and suprasternal views will be used. The end-diastolic left ventricular internal dimension (LVIDd), end-diastolic left ventricular posterior wall thickness (LVPWd) and end-diastolic interventricular septum (IVSd)) values will be determined by echocardiographic examination. Left ventricular mass will be calculated by the formula of Devereux et al. (1986) which has been validated for use in children with normal hearts: LVM (g)=0.8 {1.04((IVST+LVID+LVPWT)3 –LVID3)} +0.6

 

The children will be divided into 6 groups according to their BSA: 0.20-0.25 m2 , 0.25-0.50 m2 , 0.50-0.75 m2 , 0.75-1.0 m2 , 1.0-1.25 m2 , and 1.25-1.50 m2 . The means, ±SD of LVIDd, LVPWd, IVSd, LVM and LVM/BSA values will be estimated for all groups.

Aim:To find out the correlation between Anthropometry with Left Ventricular Mass in Normal Rural Children.

 
Close