Randomized Study of Human-Milk Based Nutrition Versus Formula in Premature Infants

Infant, Very Low Birth Weight Clinical Trial

Official title: A Randomized Study of Human Milk-Based Versus Bovine-based Nutrition for Very Low Birth Weight Pre-Term Infants

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Birth Weight
• Infant, Very Low Birth Weight

• NCT number: NCT00506584
• Study type: Interventional
• Source: Prolacta Bioscience
• Status: Completed
• Phase: N/A
• Start date: July 2007
• Completion date: July 2008