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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  
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 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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Born in BKL Walawalkar Hosptal between January 2016 to December 2018 
 
Intervention / Comparator Agent  
Type  Name  Details 
 
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. 


 
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