Randomized Study of Human-Milk Based Nutrition Versus Formula in Premature Infants
Condition: Infant, Very Low Birth Weight
MeSH terms: Birth Weight
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether very low birth weight infants (less than or
      equal to 1250g or about 2 3/4 pounds) born prematurely fed a diet of only human milk and
      human milk-derived nutrition have better health outcomes than babies fed at least some
      formula (made from cow's milk)or formula-derived nutrition.
    

Detailed description: 
      The goal of this study is to evaluate the short-term effect (up to 90 days of life) of purely
      human-based nutrition using mother's own milk (when available), donor milk preparations and a
      human-based fortifier (Prolact+4) as needed when compared with mother's own milk supplemented
      with pre-term formula and using a bovine-based HMF (as needed for fortification of mother's
      own milk), i.e. "Study Group 1"; or, when mother's milk is not available, comparing the use
      of donor milk (plus human milk based fortification) with pre-term/term formula, i.e. "Study
      Group 2". In both instances the comparison will be based on the primary endpoint of days of
      TPN, and on parameters such as time to full enteral feeding (approximately 150-160
      mL/kg/day), amount of IV fluid support, culture-proven sepsis, NEC, death, growth and
      short-term development, cultured-proven sepsis and incidence of feeding intolerance in either
      a 2-arm (human nutrition versus bovine nutrition: "Study Group 2") or 3-arm randomized design
      (human fortifier given when feedings reach 40 mL/kg/day, human fortifier given when feedings
      reach 100 mL/kg/day, and bovine-based HMF given when feedings reach 100 mL/kg/day [or
      pre-term formula if mother's milk is not available]: "Study Group 1").

      Statistically, the study will attempt to evaluate a null hypothesis of equivalent results
      with respect to these parameters between either the three types of fortifications in "Study
      Group 1" or the two types of overall nutrition in "Study Group 2", as compared with an
      alternative of some inequality between the groups, i.e. letting μ be the mean number of days
      of TPN any of the study arms, then for "Study Group 1 the hypotheses may be written as:

      H0: μ control = μ human 40 = μhuman 100 and HA: At least two of μ control, μ human 40, and
      μhuman 100 are not equal, where "control" is the bovine-based HMF group, "human 40" is the
      human fortifier group starting at 40 mL/kg/day (arm 2) and "human 100" is the human fortifier
      group starting at 100 mL/kg/day (arm 1). For "Study Group 2", the competing hypotheses are:
      H0: μ formula = μ human and HA: μ formula ≠ μ human , where "formula" is the pre-term/term
      formula group and "human" is the human-based (donor milk/human-based fortifier) group.

      In addition, data will be collected on overall survival and length of stay in the NICU. Any
      baby that does not complete the full study period will be right-censored in this regard for
      the purposes of data evaluation. For centers that obtain long-term follow up (18-24 months)
      on their patients, data on developmental outcomes will be evaluated as available.
    

Intervention name(s): Pasteurized human milk and pasteurized human milk fortifier; Pasteurized human milk and pasteurized human milk fortifier; Human milk fortifier (bovine-based), pre-term formula; Pasteurized human milk and pasteurized human milk fortifier; Pre-term/term formula
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Human milk fortifier is initiated when nutrition volume reaches 100 mL/kg/day; Human milk fortifier is initiated when nutrition volume reaches 40 mL/kg/day; Bovine-based human milk fortifier is initiated when nutrition volume reaches 100 mL/kg/day; Human milk fortifier initiated when nutrition volume reaches 100 mL/kg/day; Bovine milk-derived nutrition formulated for very low birth weight infants
Other intervention name(s): Prolact20/Neo20; Prolact+4; Prolact20/Neo 20; Prolact+4; Prolact20/Neo20; Prolact+4
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Human milk nutritional intervention; Pre-term, very low birth weight; Fortification of human breast milk