| 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
|
|
|
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
|
|
|
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
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response (Others) - by email id
- 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.
- 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. |