Low-birthweight Infant Feeding Exploration
Condition: Low Birthweight; Pre-Term
MeSH terms: Birth Weight
Study type: Observational

Summary: 
      Globally, 15% of all babies, amounting to 20 million infants each year, are born low
      birthweight (LBW), defined less than 2500 grams (5.5 lbs). Compared to normal weight infants,
      LBW infants are at higher risk of morbidity, mortality, and poor growth (Risnes et al 2011;
      Larroque et al 2001; WHO 2006). The main causes of LBW are preterm birth, intrauterine growth
      restriction (IUGR), or their combination. Unfortunately, there is a paucity of information
      around feeding practices and optimal feeding strategies for this population, particularly for
      LBW infants who struggle with breastfeeding or growth. This study hopes to address these
      gaps.
    

Detailed description: 
      The Low-birthweight Infant Feeding Exploration (LIFE)(original grant 0-6 months of age) and
      the 6- month extension (6-12 months of age) will fill a critical data gap in the field of
      newborn care regarding vulnerability and feeding of LBW infants. The investigators aim to
      establish the background information required to set up and test the most efficient and
      feasible infant feeding strategies for LBW infants: first to support breastfeeding, and then
      to support infants who are nutritionally at risk in the first 6 month of life in low and
      middle income countries (LMIC). The investigators 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.

      In addition, this 6-month extension will allow for a more comprehensive exploration and
      understanding of feeding options for LBW infants from 6 to 12 months of age, accounting for
      timing of introduction of complementary liquids and foods, 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. Specifically, we
      will be able to describe the following for LBW infants:

        -  Growth trajectories from 0 to 12 months of age

        -  Patterns and timing of complementary feeding and continued breastfeeding/breastmilk
           consumption

        -  Common infant morbidities and timing of mortality

        -  Maternal demographics, well-being and environmental factors affecting infant feeding and
           growth

      The overall study goal is to understand feeding options for LBW infants in LMIC settings,
      including current feeding practices, health outcomes, and potential interventions. The study
      will take place in four study sites located in three countries: Tanzania, Malawi, and India.
      Each study site will encompass 2 to 5 individual study facilities. The three study objectives
      under the goal include:

        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

      The investigators will also use the results of this work to design ways to support exclusive
      breastfeeding (including strategies for feeding with MOM), and to support other options, when
      mother's own milk (MOM) is unavailable or infants are nutritionally at risk. To do this, the
      investigators will engage in discussion and consensus-building activities among study staff
      and key stakeholders, using the collected study data to inform feasible, acceptable Infant
      and Young Child Feeding (IYCF) strategies for LBW infants that include specific options for
      those who are nutritionally at risk. The strategies will be tailored to the country as much
      as possible. A primary product for this later stage will be a white paper documenting key
      findings from the research and proposing feeding strategies for LBW infants in study sites.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Mothers and their LBW babies who are either born in the study health facilities or arrive
        within 72 hours of birth and meet eligibility criteria
      
Keywords: Infant Health; Low and Middle Income Countries [LMIC]; Maternal Health; Infant Feeding; Low Birthweight