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
|
|
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
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: P071||Other low birth weight newborn, |
|
Intervention / Comparator Agent
|
|
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 |