Evaluation of Prolact-Plus Human Milk Fortifier (NCT00486590) | Clinical Trial Compass
CompletedNot Applicable
Evaluation of Prolact-Plus Human Milk Fortifier
United States105 participantsStarted 2006-08
Plain-language 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 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.
Who can participate
Age range
1 Day – 30 Days
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Between 23 and 32 weeks gestational age
. Weigh between 500 and 1600g
. In the retrospective group, an infant must have been able to adhere to a feeding protocol that included only mother's own milk fortified by either bovine or human product from the time that enteral feeding began (or whenever fortified human milk feeding began) through the next 30 days of life or hospital discharge, whichever came first.
. In the prospective group, the infant must be expected to be able to adhere to a feeding protocol that includes only mother's own milk fortified by the human product from the time that enteral feeding began (or whenever fortified human milk feeding began) through the next 30 days of life or hospital discharge, whichever comes first.
. Informed consent obtained from parent or legal guardian.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.