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CTRI Number  CTRI/2024/07/071552 [Registered on: 30/07/2024] Trial Registered Prospectively
Last Modified On: 11/07/2024
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Normal value of Heart Rate Variability among Normal Indian Children  
Scientific Title of Study   Normative Data of Heart-Rate variability among Healthy 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  Kaushal Dipakbhai Bhatt 
Designation  Phd Scholar 
Affiliation  Government Medical College, Bhavnagar 
Address  KIDS Pediatric Physiotherapy Clinic, 2nd floor, Sukhshanti Complex, Kalanala, Bhavnagar

Bhavnagar
GUJARAT
364001
India 
Phone  9979434249  
Fax    
Email  kaushaldbhatt007@yahoo.co.in  
 
Details of Contact Person
Scientific Query
 
Name  Dr Chinmay Shah 
Designation  Professor & HOD, Dept of Physiology 
Affiliation  Government Medical College, Bhavnagar 
Address  Department of Physiology, Government Medical College, Bhavnagar

Bhavnagar
GUJARAT
364001
India 
Phone  9328938008  
Fax    
Email  cjshah79@yahoo.co.in  
 
Details of Contact Person
Public Query
 
Name  Dr Chinmay Shah 
Designation  Professor & HOD, Dept of Physiology 
Affiliation  Government Medical College, Bhavnagar 
Address  Department of Physiology, Government Medical College, Bhavnagar

Bhavnagar
GUJARAT
364001
India 
Phone  9328938008  
Fax    
Email  cjshah79@yahoo.co.in  
 
Source of Monetary or Material Support  
Dept of Physiology, Govenment Medical College, Bhavnagar, India - 364001 
 
Primary Sponsor  
Name  GMC Bhavnagar 
Address  Department of Physiology, Government Medical College Bhavnagar, India - 364001 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Chinamy Shah  Government Medical College   Dept Of Physiology, Government Medical College & Sir T Hospital, Bhavnagar
Bhavnagar
GUJARAT 
9328938008

cjshah79@yahoo.co.in 
Dr Mehul Gosai  Sir T Hospital Bhavnagar  Dept of Pediatrics, Sir T Hospital, Bhavnagar
Bhavnagar
GUJARAT 
9979514514

drmehulgosai78@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Ethics Committee, GMC, Bhavnagar   Approved 
Ethics Committee, GMC, Bhavnagar  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy Children from birth to 12 years 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  1.00 Day(s)
Age To  12.00 Year(s)
Gender  Both 
Details  Apparently healthy children
Child with normal age specific development

 
 
ExclusionCriteria 
Details  1.Past history of any medical disorder in last 2 months.
2.After 2 hours of vigorous physical activity like sports or play.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Heart Rate Variability Time and Frequency domain   5 min recording 
 
Secondary Outcome  
Outcome  TimePoints 
Normative Data of frequency and time domain of HRV  Short term 5 min recording 
 
Target Sample Size   Total Sample Size="387"
Sample Size from India="387" 
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)   15/08/2024 
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="1"
Days="15" 
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 - NO
Brief Summary  

heart rate variability (HRV) has been considered as valuable non-invasive test that has been used to investigate the function of the autonomic nervous system. In severe conditions HRV tend to reduce. This is based on the fact that the spatial and temporal variations in heart rate, reflect changes of sympathetic and vagal activity, following postural changes and or physical activity in neonates. Importantly, evidence suggests that the neurocardiac mechanism in high risk infants with neurological damage are less efficient, and less adaptive to exercise, postural change, and physical activity, compared to infants with less or no damage.

Considering this association, HRV has been suggested as a possible marker of brain damage, neurodevelopmental dysfunction, and improvement following exercises, activities, and therapeutic physiotherapeutic interventions. Thus, parameters related to HRV have been used as physiological markers reflective of motoric control, function, and neuromotor developmental level, and milestones

 

 
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