| 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
|
|
|
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
|
|
|
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 |