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NCT00486590 · ClinicalTrials.gov registry record · NA
Evaluation of Prolact-Plus Human Milk Fortifier
A NA study of Infant, Very Low Birth Weight, sponsored by Prolacta Bioscience.
- Completed
- Registry status
- NA
- Development phase
- 105
- Enrollment target
- 4
- Study locations
NCT00486590: Completed NA study of Infant, Very Low Birth Weight, sponsored by Prolacta Bioscience.
NCT00486590 is a NA study of Infant, Very Low Birth Weight that has completed, run by Prolacta Bioscience. The registered enrollment target is 105 participants, below the 281-participant average among 4 other Infant, Very Low Birth Weight trials with a reported enrollment target (63% lower). The trial reports 4 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00486590, a NA study of Infant, Very Low Birth Weight, has completed, sponsored by Prolacta Bioscience.
- COMPLETED
- Registry status
- NA
- Development phase
- 105 participants
- Enrollment target
- 4
- Study locations
Study Summary
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 o
Conditions Studied
Interventions
- PROCEDURE Prolact-Plus Human Milk Fortifier
Study Locations (4)
Florida
- Shands Children's Hospital - Gainesville
- Joe DiMaggio Children's Hospital - Hollywood
- Miami Children's Hospital - Miami
Indiana
- Memorial Hospital of South Bend - South Bend
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 105 participants |
| Start Date | 2006-08 |
| Est. Completion | 2007-08 |
| Phase | NA |
What the finished NCT00486590 record still lists
NCT00486590 is an interventional study that assigns participants to a tested intervention. The registered 105 participants enrollment target is mid-sized for trials with a published cap, below the 281-participant average among 4 other Infant, Very Low Birth Weight trials with a reported enrollment target (63% lower).
The record links to 1 condition, with Infant, Very Low Birth Weight appearing as the primary indexed condition, and to 1 intervention - of which Prolact-Plus Human Milk Fortifier is the first listed.
NCT00486590 reports a single indexed study location in Florida, Indiana.
Frequently Asked Questions
What is clinical trial NCT00486590 about?
NCT00486590 is a clinical study titled "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...
What is the current status of trial NCT00486590?
This trial is currently completed. It is a NA study. The enrollment target is 105 participants. The study started on 2006-08. Estimated completion is 2007-08.
What conditions does trial NCT00486590 study?
This clinical trial studies the following conditions: Infant, Very Low Birth Weight.
What interventions are being tested in trial NCT00486590?
The interventions under investigation include: Prolact-Plus Human Milk Fortifier (PROCEDURE).
Who is sponsoring clinical trial NCT00486590?
This trial is sponsored by Prolacta Bioscience, which has 7 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00486590 being conducted?
This trial has 4 study locations across Florida, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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