Low-birthweight Infant Feeding Exploration
- Conditions
- Other low birth weight newborn,
- Registration Number
- CTRI/2019/02/017475
- Lead Sponsor
- Bill and Melinda Gates Foundation
- 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 birthweightinfants (LBWs) prioritize, in this order, the mother’s own breast milk (MOM),donor human milk (DHM), and then breast milk substitute/formula (BMS). Macro ormicronutrient supplementation is not currently recommended, and the guidelinesoffer limited insight into the implementation of these policies. Moreover, 70%of the guidelines are based on “low or very low†quality of evidence (WHOInfant Feeding Guidelines 2011).
Recently,a call to action for investigation of infant feeding practices for vulnerablenewborns highlighted the deep lack of knowledge around the current careprovision for vulnerable newborns, as well as what the optimal infant feeding“ecosystem†is that supports breastfeeding and offers appropriate alternativeswhen infants are nutritionally at risk (Greenslade et al 2017).
Infantfeeding is a very sensitive subject with deeply held beliefs, globally. At theend of the investment, we will have answered key questions around currentinfant feeding practices of low birthweight children who are at heightened riskof morbidity, mortality and poor development. Additionally, we will identifykey systems gaps to understand how and why breastfeeding is unsuccessful. Thiswork will provide new evidence to guide improved nutritional support for the 20million low birthweight infants born each year and fill a massive data gapwhich currently results in suboptimal programs and systems. In particular, thiswork will provide guidance for the needed efficacy and effectiveness trials forinfant in LMICs, where 90% of LBW occurs, and where causes of morbidity andmortality 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 feedingoptions 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-levelIYCF intervention and the proposed infant feeding options for LBW infants
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 1200
Mother/infant pairs-Infant birthweight between 1500 and less than 2500 g Residence within catchment area of facility Mother’s consent.
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.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Understand feeding options for LBW infants in LMIC settings, including current Birth to 6 months of infant age feeding practices, health outcomes, and potential interventions Birth to 6 months of infant age
- Secondary Outcome Measures
Name Time Method Understand the current practices and standard Define and document the key outcomes Assess the acceptability and feasibility of a
Trial Locations
- Locations (4)
JJM Medical College and Bapuji Child Health Institute
🇮🇳Davanagere, KARNATAKA, India
KLES Dr Prabhakar Kore Hospital and Medical Research Centre Belgaum
🇮🇳Belgaum, KARNATAKA, India
S. S. Institute of Medical Sciences and Research Centre
🇮🇳Davanagere, KARNATAKA, India
Srirama Chandra Bhanja Medical College and Hospital
🇮🇳Cuttack, ORISSA, India
JJM Medical College and Bapuji Child Health Institute🇮🇳Davanagere, KARNATAKA, IndiaDr Guruprasad GPrincipal investigator9844065889dr_g_gp@yahoo.com