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CTRI Number  CTRI/2019/02/017475 [Registered on: 05/02/2019] Trial Registered Prospectively
Last Modified On: 19/09/2022
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   Low-birthweight Infant Feeding Exploration 
Scientific Title of Study   Low-birthweight Infant Feeding Exploration 
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 Shivaprasad S Goudar 
Designation  Professor of Physiology 
Affiliation  KLE Academy of Higher Education and Researchs J N Medical College 
Address  Professor Department of Physiology, KLE Universitys J N Medical College Nehru Nagar Belgaum Principal Investigator Womens and Childrens Health Research Unit Wing

Belgaum
KARNATAKA
590010
India 
Phone  08312472891  
Fax  8312472891  
Email  sgoudar@jnmc.edu  
 
Details of Contact Person
Scientific Query
 
Name  Dr Shivaprasad S Goudar 
Designation  Professor of Physiology 
Affiliation  KLE Academy of Higher Education and Researchs J N Medical College 
Address  Professor Department of Physiology, KLE Universitys J N Medical College Nehru Nagar Belgaum Principal Investigator Womens and Childrens Health Research Unit Wing


KARNATAKA
590010
India 
Phone  08312472891  
Fax  8312472891  
Email  sgoudar@jnmc.edu  
 
Details of Contact Person
Public Query
 
Name  Dr Shivaprasad S Goudar 
Designation  Professor of Physiology 
Affiliation  KLE Academy of Higher Education and Researchs J N Medical College 
Address  Professor Department of Physiology, KLE Universitys J N Medical College Nehru Nagar Belgaum Principal Investigator Womens and Childrens Health Research Unit Wing


KARNATAKA
590010
India 
Phone  08312472891  
Fax  8312472891  
Email  sgoudar@jnmc.edu  
 
Source of Monetary or Material Support  
Bill & Melinda Gates Foundation 
 
Primary Sponsor  
Name  Bill and 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     India
Malawi
Tanzania  
Sites of Study  
No of Sites = 4  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Guruprasad G  JJM Medical College and Bapuji Child Health Institute  Child Health Institute, Medical College Rd, MCC B Block, Kuvempu Nagar, Davanagere
Davanagere
KARNATAKA 
9844065889

dr_g_gp@yahoo.com 
Dr Shivaprasad S Goudar  KLES Dr Prabhakar Kore Hospital and Medical Research Centre Belgaum  KLE Academy of Higher Education and Researchs J N Medical College Nehru Nagar Belgaum Womens and Childrens Health Research Unit Wing
Belgaum
KARNATAKA 
9448126371

sgoudar@jnmc.edu 
Dr B S Prasad  S. S. Institute of Medical Sciences and Research Centre  NH-4, Bypass Road, Davangere-577005
Davanagere
KARNATAKA 
9243312890

umaprasadbs@yahoo.com 
Dr Leena Das  Srirama Chandra Bhanja Medical College and Hospital   Manglabag, Cuttack-753007, Odisha, India
Cuttack
ORISSA 
9437271989

leena_das@yahoo.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 5  
Name of Committee  Approval Status 
Institutional Ethics Committee JJM Medical College Davangere  Approved 
Institutional Ethics Committee S S Institute of Medical Sciences Davangere  Approved 
Institutional Ethics Committee SCB Medical College Cuttack  Approved 
Institutional Ethics Committee, KLE Academy of Higher Education and Research, Belagavi  Approved 
Research and Ethics Committee, DHS, Odisha   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  0.00 Day(s)
Age To  45.00 Year(s)
Gender  Both 
Details  Mother/infant pairs-Infant birthweight between 1500 and less than 2500 g
Residence within catchment area of facility
Mother’s consent 
 
ExclusionCriteria 
Details  Mother/infant pairs-Infant very low birthweight
Congenital abnormality that interferes with feeding
Critical or severe illness jeopardizing early survival
Plans to leave the study area before end of data collection
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Understand feeding options for LBW infants in LMIC settings, including current
feeding practices, health outcomes, and potential interventions 
Birth to 6 months of infant age 
 
Secondary Outcome  
Outcome  TimePoints 
Understand the current
practices and standard
of care (SOC) for
feeding LBW infants 
Birth to 6 months of infant age 
Define and document
the key outcomes
(including growth,
morbidity, and lack of
success on MOM) for
LBW infants under
current practices 
Birth to 6 months of infant age 
Assess the acceptability
and feasibility of a
system-level IYCF
intervention and the
proposed infant feeding
options for LBW infants 
Birth to 6 months of infant age 
 
Target Sample Size   Total Sample Size="1200"
Sample Size from India="600" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/04/2019 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  01/03/2019 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Globally, more than 20 million infants each year are born low birthweight (<2500g); these newborns are at higher risk of mortality, morbidity, and poor growth. Current World Health Organization (WHO) guidelines for feeding low birthweight infants (LBWs) prioritize, in this order, the mother’s own breast milk (MOM), donor human milk (DHM), and then breast milk substitute/formula (BMS). Macro or micronutrient supplementation is not currently recommended, and the guidelines offer limited insight into the implementation of these policies. Moreover, 70% of the guidelines are based on “low or very low” quality of evidence (WHO Infant Feeding Guidelines 2011).

 Recently, a call to action for investigation of infant feeding practices for vulnerable newborns highlighted the deep lack of knowledge around the current care provision for vulnerable newborns, as well as what the optimal infant feeding “ecosystem” is that supports breastfeeding and offers appropriate alternatives when infants are nutritionally at risk (Greenslade et al 2017).

 Infant feeding is a very sensitive subject with deeply held beliefs, globally. At the end of the investment, we will have answered key questions around current infant feeding practices of low birthweight children who are at heightened risk of morbidity, mortality and poor development. Additionally, we will identify key systems gaps to understand how and why breastfeeding is unsuccessful. This work will provide new evidence to guide improved nutritional support for the 20 million low birthweight infants born each year and fill a massive data gap which currently results in suboptimal programs and systems. In particular, this work will provide guidance for the needed efficacy and effectiveness trials for infant in LMICs, where 90% of LBW occurs, and where causes of morbidity and mortality are significantly different than those in High Income Countries (HIC), where most evidence is generated around infant feeding (Blencowe 2013).

Study goal is to understand feeding options for LBW infants in LMIC settings, including current feeding practices, health outcomes, and potential interventions.

 Objectives:

1.    Understand the current practices and standard of care (SOC) for feeding LBW infants

2.    Define and document the key outcomes (including growth, morbidity, and lack of success on MOM) for LBW infants under current practices

3.    Assess the acceptability and feasibility of a system-level IYCF intervention and the proposed infant feeding options for LBW infants

 
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