Ignite Creation Date:
2024-05-05 @ 6:35 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00506584
Status:
COMPLETED
Last Update Posted:
2010-02-18
First Post:
2007-07-20
Brief Title:
Randomized Study of Human-Milk Based Nutrition Versus Formula in Premature Infants
Sponsor:
Prolacta Bioscience
Organization:
Prolacta Bioscience
Study Overview
Official Title:
A Randomized Study of Human Milk-Based Versus Bovine-based Nutrition for Very Low Birth Weight Pre-Term Infants
Status:
COMPLETED
Status Verified Date:
2010-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine whether very low birth weight infants less than or equal to 1250g or about 2 34 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 cows milkor 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 mothers own milk when available donor milk preparations and a human-based fortifier Prolact4 as needed when compared with mothers own milk supplemented with pre-term formula and using a bovine-based HMF as needed for fortification of mothers own milk ie Study Group 1 or when mothers milk is not available comparing the use of donor milk plus human milk based fortification with pre-termterm formula ie 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 mLkgday 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 mLkgday human fortifier given when feedings reach 100 mLkgday and bovine-based HMF given when feedings reach 100 mLkgday or pre-term formula if mothers 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 ie 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 mLkgday arm 2 and human 100 is the human fortifier group starting at 100 mLkgday 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-termterm formula group and human is the human-based donor milkhuman-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
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 ie 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 mLkgday arm 2 and human 100 is the human fortifier group starting at 100 mLkgday 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-termterm formula group and human is the human-based donor milkhuman-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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None