FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2021/09/036231 [Registered on: 03/09/2021] Trial Registered Prospectively
Last Modified On: 19/10/2022
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Other 
Public Title of Study   Infant Feeding practices in small babies for 24 months 
Scientific Title of Study   Low-birthweight Infant Feeding Exploration 24-Month Evaluation 
Trial Acronym  LIFE 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Roopa M Bellad 
Designation  Professor Paediatrics 
Affiliation  J N Medical College KAHER Belagavi 
Address  Department of Paediatrics J N Medical College KLE Academy of Higher Education and Research (Deemed-to-be-University) Nehru Nagar Belagavi

Belgaum
KARNATAKA
590010
India 
Phone  9448113403  
Fax    
Email  belladroopa5@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Roopa M Bellad 
Designation  Professor Paediatrics 
Affiliation  J N Medical College KAHER Belagavi 
Address  Department of Paediatrics J N Medical College KLE Academy of Higher Education and Research (Deemed-to-be-University) Nehru Nagar Belagavi


KARNATAKA
590010
India 
Phone  9448113403  
Fax    
Email  belladroopa5@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Roopa M Bellad 
Designation  Professor Paediatrics 
Affiliation  J N Medical College KAHER Belagavi 
Address  Department of Paediatrics J N Medical College KLE Academy of Higher Education and Research (Deemed-to-be-University) Nehru Nagar Belagavi


KARNATAKA
590010
India 
Phone  9448113403  
Fax    
Email  belladroopa5@gmail.com  
 
Source of Monetary or Material Support  
Bill & Melinda Gates Foundation USA  
 
Primary Sponsor  
Name  Bill Melinda Gates Foundation  
Address  440 5th Ave N Seattle WA 98109 USA 
Type of Sponsor  Other [Charitable Foundation] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     Tanzania
India  
Sites of Study  
No of Sites = 3  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Guruprasad G  JJM Medical College and Bapuji Child Health Institute Davanagere  Department of Paediatrics Child Health Institute Medical College Rd MCC B Block Kuvempu Nagar Davanagere 577004 KARNATAKA
Davanagere
KARNATAKA 		 9844065889

dr_g_gp@yahoo.com 
Dr Roopa M Bellad  KLES Dr Prabhakar Kore Hospital and Medical Research Centre Belgaum  Department of Paediatrics J N Medical College Womens and Childrens Health Research Unit Wing KLE Academy of Higher Education and Research Nehru Nagar 590010 Belgaum
Belgaum
KARNATAKA 		 9448113403

belladroopa5@gmail.com 
Dr B S Prasad  S S Institute of Medical Sciences and Research Centre Davanagere  Department of Paediatrics SS Institute of Medical Sciences NH-4 Bypass Road Davangere 577005
Davanagere
KARNATAKA 		 9243312890

umaprasadbs@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 3  
Name of Committee  Approval Status 
Institutional Ethics Committee JJM Medical College Davangere  Approved 
Institutional Ethics Committee KLE Academy of Higher Education and Research Belagavi  Approved 
Institutional Ethics Review Board S S Institute of Medical Sciences and Research Centre Davangere  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: P071||Other low birth weight newborn,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  1.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  Mother/ Infant pair are
1. Currently enrolled in the LIFE study and extension (follow-up from birth to 1 year of age) and fulfills all original inclusion criteria (infant birthweight between 1500g and <2500g, residence in catchment area of facilities in which born)
2. Mothers consent obtained for herself and infant for another 12 month of follow up
3. That the mother /child (dyad) did not withdraw or the baby did not die 
 
ExclusionCriteria 
Details  Mother/ Infant pairs
1. Not previously enrolled in the LIFE study in addition to all original exclusion criteria
(birthweight outside range, congenital abnormalities at birth, neonatal encephalopathy at birth, young mother, maternal death during labor and delivery, infant death before 72 hours of life, infant is more than 72 hours old at enrollment) 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Growth trajectories from 12 to 24 months of age  12 to 24 months of age 
 
Secondary Outcome  
Outcome  TimePoints 
Understand the relationship between infant growth at 24 months and child development at 24 months   Up to 24 months of age 
Examine the predictors (Ex: duration of breast feeding, maternal depression, hospitalizations, demographics etc.) of infant growth (WAZ/LAZ/WLZ) at 24 months  Up to 24 months of age 
Examine the predictors (Ex: duration of breastfeeding, maternal depression, family care indicators, demographics etc.) of child development at 24 months  Up to 24 months of age 
 
Target Sample Size   Total Sample Size="597"
Sample Size from India="289" 
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)   06/09/2021 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  01/08/2021 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Closed to Recruitment of Participants 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response (Others) -  Researchers whose proposed use of the data has been approved by Trial Steering Committee.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response (Others) -  Communication with representatives of Trial Steering committee by email; Dr Roopa M Bellad (belladroopa5@gmail.com) and Dr Shivaprasad S Goudar (sgoudar@jnmc.edu)

  6. For how long will this data be available start date provided 01-11-2022 and end date provided 13-11-2027?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary
Modification(s)  

The overall study goal is to understand feeding options for LBW infants in LMIC settings up to 24 months of age, including current feeding practices, child development, health and growth outcomes and potential interventions. The study will take place in two countries: Tanzania and India. Each country will encompass 3 to 5 individual study facilities. 
This study is an extension of the research project titled LIFE Extension: Low-birthweight Infant Feeding Exploration Extension which is previously registered in CTRI (CTRI No: CTRI/2020/06/026004). It will fill a critical data gap in the field of new born care regarding feeding LBW infants. We aim to establish the background information required to set up and test the most efficient and feasible infant feeding strategies for LBW infants: to support infants who are nutritionally at risk in the first 24 months of life in LMICs. We will explore all three infant feeding options currently included in the WHO guidelines for LBW infants (WHO 2011), namely mother’s own milk (MOM), donor human milk (DHM), and breast milk substitute or formula (BMS), in that order. This work will provide much-needed evidence to inform infant feeding guidelines.
Specifically, we will be able to describe the following for these LBW infants:
1. Duration of time fed breastmilk and when stopped 
2. Maternal depression
3. Morbidity and care-seeking
4. Cognitive and motor development and family care indicators
5. Vital status (maternal and infant death and withdrawals)
This study will allow for a more comprehensive exploration and understanding of feeding options for LBW infants from 12 to 24 months of age, changes in feeding types, growth and health outcomes over the entire infancy period. This will contribute significantly and allow for high quality data to describe the burden of disease across sites.

 
Close