Infant Feeding practices in small babies for 24 months

Active, not recruiting

Conditions: Other low birth weight newborn,

Registration Number: CTRI/2021/09/036231

Lead Sponsor: Bill Melinda Gates Foundation

Brief Summary: The overall studygoal is to understand feeding options for LBW infants in LMIC settings up to 24months of age, including current feeding practices, child development, healthand growth outcomes and potential interventions. The study will take place in twocountries: Tanzania and India. Each country will encompass 3 to 5 individualstudy facilities. This study is an extension of the research projecttitled LIFE Extension: Low-birthweight Infant Feeding Exploration Extension whichis previously registered in CTRI (CTRI No: CTRI/2020/06/026004). It willfill a critical data gap in the field of new born care regarding feeding LBWinfants. We aim to establish the background information required to set up andtest 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 lifein LMICs. We will explore all three infant feeding options currently includedin the WHO guidelines for LBW infants (WHO 2011), namely motherâ€™s own milk(MOM), donor human milk (DHM), and breast milk substitute or formula (BMS), inthat order. This work will provide much-needed evidence to inform infantfeeding guidelines. **Specifically, we will be able to describe thefollowing for these LBW infants:** 1. Duration of time fed breastmilk and whenstopped 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 andunderstanding of feeding options for LBW infants from 12 to 24 months of age,changes in feeding types, growth and health outcomes over the entire infancyperiod. This will contribute significantly and allow for high quality data todescribe the burden of disease across sites.

Detailed Description: Not available

Recruitment & Eligibility

Status: Closed to Recruitment of Participants

Sex: All

Target Recruitment: 597

Inclusion Criteria

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.

Exclusion Criteria

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).

Study & Design

Study Type: Observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Growth trajectories from 12 to 24 months of age	12 to 24 months of age

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (3): JJM Medical College and Bapuji Child Health Institute Davanagere
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Davanagere, KARNATAKA, India
KLES Dr Prabhakar Kore Hospital and Medical Research Centre Belgaum
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Belgaum, KARNATAKA, India
S S Institute of Medical Sciences and Research Centre Davanagere
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Davanagere, KARNATAKA, India
JJM Medical College and Bapuji Child Health Institute Davanagere
🇮🇳Davanagere, KARNATAKA, India
Dr Guruprasad G
Principal investigator
9844065889
dr_g_gp@yahoo.com