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Metadata

Name
Evaluation of Prolact-Plus Human Milk Fortifier
Repository
ClinicalTrials.gov
Identifier
clinicaltrials:NCT00486590
Description
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.
Data or Study Types
clinical trial
Keywords
Human milk fortification, Premature neonate, Very low birth weight
Source Organization
Unknown
Access Conditions
available
Year
2007
Access Hyperlink
https://clinicaltrials.gov/ct2/show/NCT00486590

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