Evaluation of Prolact-Plus Human Milk Fortifier
Prolacta Bioscience has developed the first purely human fortifier, Prolact-Plus, that can provide a source of many of the required nutrients for premature, newborn infants, particularly protein and calories. This product is made from donor human milk from which the skim (non-lipid portion) has been separated and then concentrated. A certain amount of the lipid content has been added back to achieve higher caloric content within a small delivery volume. The product is then pasteurized and filled in small quantities in order to allow for the addition of mother's own milk (or, possibly, milk from another donor). The goal of the preparation is to achieve an increase of approximately 4 cal/oz of mother's milk and to provide a protein level (when mixed with average pre-term milk) of about 3.5-3.8 g/100 Kcal of feed.
The data on Prolact-Plus will be obtained prospectively from infants who will receive human milk fortified in this fashion. The data on standard,bovine (cow)-fortified milk will be obtained retrospectively from medical records at the participating institutions. While this design is not necessarily optimal in this setting, it is an efficient and quick approach to evaluating the acute clinical effect of Prolact-Plus. It is anticipated that further studies will be conducted that will examine longer-term accounts and possibly do this in a controlled, randomized environment.
The goal of this study is to evaluate the short-term effect of Prolact-Plus fortified human milk when compared with bovine-based fortification of human milk on parameters such as growth and short-term development, infectious complications and incidence of feeding intolerance in a cohort design. Statistically, the study will attempt to evaluate a null hypothesis of equivalent results with respect to these parameters between the two types of fortifiers as compared with a two-sided alternative (difference between the groups).
In addition, data will be collected on overall survival and length of stay in the NICU. These data will be collected for descriptive purposes, although an attempt will be made to compare the findings with those obtained from the bovine-based fortifier.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
|Official Title:||The Evaluation of Prolact-Plus, Human Milk Fortifier (Human, Pasteurized) for Pre-Term Infants Receiving Human Milk|
- Feeding intolerance [ Time Frame: 30 days ] [ Designated as safety issue: No ]
- Necrotizing enterocolitis [ Time Frame: 30 days ] [ Designated as safety issue: No ]
- Length of stay in NICU and hospital [ Time Frame: Indeterminate ] [ Designated as safety issue: No ]
- Growth parameters, e.g. weight, head circumference, and length [ Time Frame: 30 days ] [ Designated as safety issue: No ]
|Study Start Date:||August 2006|
|Study Completion Date:||August 2007|
|Primary Completion Date:||August 2007 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00486590
|United States, Florida|
|Shands Children's Hospital|
|Gainesville, Florida, United States, 32610-0296|
|Joe DiMaggio Children's Hospital|
|Hollywood, Florida, United States, 33021|
|Miami Children's Hospital|
|Miami, Florida, United States, 33155|
|United States, Indiana|
|Memorial Hospital of South Bend|
|South Bend, Indiana, United States, 46601|
|Study Director:||Martin L Lee, PhD||Prolacta Bioscience|