CTRI Number |
CTRI/2019/04/018741 [Registered on: 24/04/2019] Trial Registered Prospectively |
Last Modified On: |
18/04/2019 |
Post Graduate Thesis |
No |
Type of Trial |
Observational |
Type of Study
|
Cohort Study |
Study Design |
Single Arm Study |
Public Title of Study
|
Walawalkar Hospital Fetuses and Infants (WIFI) cohort |
Scientific Title of Study
|
Follow up of babies born in BKLWH (Setting up longitudinal WIFI cohort) |
Trial Acronym |
WIFI |
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Suvarna Patil |
Designation |
Medical Director |
Affiliation |
BKL Walawalkar Hospital and Rural medical College |
Address |
BKL Walawalkar Hospital and Rural medical college
Sawarde
Taluka-Chiplun
Ratnagiri MAHARASHTRA 415606 India |
Phone |
9921251695 |
Fax |
|
Email |
dr.suvarnanpatil@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Charudatta Joglekar |
Designation |
Biostatistician |
Affiliation |
BKL Walawalkar Hospital and Rural medical College |
Address |
BKL Walawalkar Hospital and Rural medical College
Sawarde
Taluka-Chiplun
Ratnagiri MAHARASHTRA 415606 India |
Phone |
9822874350 |
Fax |
|
Email |
charu.joglekar@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Suvarna Patil |
Designation |
Medical Director |
Affiliation |
BKL Walawalkar Hospital and Rural medical college |
Address |
BKL Walawalkar Hospital and Rural medical College
Sawarde
Taluka-Chiplun
Ratnagiri MAHARASHTRA 415606 India |
Phone |
9921251695 |
Fax |
|
Email |
dr.suvarnanpatil@gmail.com |
|
Source of Monetary or Material Support
|
BKL Walawalkar Hospital and Rural Medical College |
|
Primary Sponsor
|
Name |
BKL Walawalkar Hospital and Rural Medical College |
Address |
Sawarde
Taluka-Chiplun
District--Ratnagiri
State-Maharashtra 415606 |
Type of Sponsor |
Private medical college |
|
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 Suvarna Patil |
BKL Walawalkar Hospital |
SawardeTaluka-Chiplun Ratnagiri MAHARASHTRA |
9921251695
dr.suvarnanpatil@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
BKL Walawalkar Rural Medical College and Hospital |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Healthy Human Volunteers |
Born in BKL Walawalkar Hosptal between January 2016 to December 2018 |
|
Intervention / Comparator Agent
|
|
Inclusion Criteria
|
Age From |
0.00 Day(s) |
Age To |
4.00 Year(s) |
Gender |
Both |
Details |
Born in BKL Walawalkar Hospital from January 2016-December 2018 |
|
ExclusionCriteria |
Details |
1)Born in BKL Walawalkar Hospital before January 2016 and after December 2018
2) Born outside BKL Walawalkar Hospital |
|
Method of Generating Random Sequence
|
Not Applicable |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
Body composition
Cognition
|
After 3 years |
|
Secondary Outcome
|
Outcome |
TimePoints |
Medical follow up |
3-5 years |
|
Target Sample Size
|
Total Sample Size="2000" Sample Size from India="2000"
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)
|
01/05/2019 |
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="3" Months="0" Days="0" |
Recruitment Status of Trial (Global)
|
Not Applicable |
Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
|
None |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
|
India is one of the diabetes capitals in the world and is expected to have more than 7 crore people with diabetes by 2030. Indians are susceptible to develop diabetes at a younger age and at a lower body mass index (BMI) compared to Europeans . The Developmental Origins of Health and Disease (DOHaD)) hypothesis also known as Barker Hypothesis proposes that early life nutrition and growth influences health and Non-communicable diseases (NCDs) risks across the life-course. Intrauterine period is the most crucial period in the life cycle and NCD risks are programmed by disturbances in maternal and fetal nutrition. Infancy is the first time window (due to its proximity to intrauterine period) in a life cycle where fetal growth in a major way is likely to influence subsequent risks in a major way. Low birthweight, diagnosis of IUGR, prematurity have been used as a proxies for poor fetal growth to predict future risks. But the association of actual fetal growth and risks for NCD’s remains largely unknown. Our prospective infant cohort will enable to investigate the associations of intrauterine life and infancy with the risk of NCD’s.
|