Infant, Very Low Birth WeightNCT00486590
Evaluation of Prolact-Plus Human Milk Fortifier
A study testing Prolact-Plus Human Milk Fortifier in people with Infant, Very Low Birth Weight, run by Prolacta Bioscience at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 day to 30 days
- Conditions the study is for
- Infant, Very Low Birth Weight
- What is being tested?
- Prolact-Plus Human Milk Fortifier
- Type of treatment
- Surgery or procedure
- How many people
- 105 participants
- Where
- 4 sitesUnited States
- Study dates
- Aug 2006to Aug 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 30 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
- Mother must be willing to adhere to a feeding protocol that includes 30 days of mother's own milk for the prospective arm of the study.
Who cannot join
- Less than a 50% probability of survival through the study period (first 30 days of enteral feeding or hospital discharge).
- On any other clinical study during the study period
- Receipt of any bovine-based formula or fortifier prior to the infant's enrollment in the study.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Shands Children's Hospital
Gainesville, Florida, 32610-0296
Joe DiMaggio Children's Hospital
Hollywood, Florida, 33021
Miami Children's Hospital
Miami, Florida, 33155
Memorial Hospital of South Bend
South Bend, Indiana, 46601
About this study
Official title: The Evaluation of Prolact-Plus, Human Milk Fortifier (Human, Pasteurized) for Pre-term Infants Receiving Human Milk
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.
Read more
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.
Read the detailed description
This will be a cohort designed study in pre-term infants (<32 weeks of gestation) comparing bovine fortified (using any one of the commercially available fortifier products) human milk with Prolact-Plus (human) fortified human milk in which the former cohort will be obtained retrospectively and the latter obtained prospectively in each participating institution. The number of infants to be included in this study is a minimum of 50 in each group who complete the 30 days on study. (If a baby drops out of the study prior to 30 days of evaluation, then they would be replaced in order to achieve that number.) This sample size was not determined statistically, but rather is based solely on the desire to obtain a reasonable amount of data to evaluate the new human fortifier in this setting. However, from the perspective of a non-inferiority evaluation of an endpoint such as feeding intolerance, consider the following. Assuming a rate of 15% for this outcome for the retrospective cohort, then with 50 subjects per cohort, the study would be able to demonstrate a lack of inferiority of the human-based fortifier with a delta of 20% using a power of slightly greater than 80% and a one-sided 2.5% significance level. (By a "delta of 20%" it is implied that a theoretical feeding intolerance rate for the Prolact-Plus of no worse than 35% would result in a conclusion of lack of inferiority with the given levels of significance and power.) Conversely, if the human-based fortifier is able to reduce the feeding intolerance rate from 15% to about 1%, then with the sample sizes in this trial, this would be doable with 80% power and 5% significance (two-sided). (Thus, the trial, in theory, also could demonstrate a dramatic reduction in this rate.) The retrospective data will be obtained from available medical charts at the participating institution and the selected infants should reflect the most recently treated (within the 12 month period prior to the initiation of the prospective phase of this protocol) and the numbers should be similar in kind to the number treated prospectively in that institution.
- Conditions
- Infant, Very Low Birth Weight
- Being tested
- Prolact-Plus Human Milk Fortifier
- Keywords
- Human milk fortification, Premature neonate, Very low birth weight
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prolact-Plus Human Milk FortifierProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Feeding intolerance
Measured: 30 days
Necrotizing enterocolitis
Measured: 30 days
Secondary outcomes (2)
Length of stay in NICU and hospital
Measured: Indeterminate
Growth parameters, e.g. weight, head circumference, and length
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2007 (estimated)
- Study startAug 2006
- Primary completionAug 2007
- Study completionAug 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infant, Very Low Birth WeightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prolacta Bioscience
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Martin L Lee, PhD, Study director, Prolacta Bioscience
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00486590
- Sponsor's protocol ID
- MPPF 001-2006
- Status last verified
- Feb 2008
- First submitted
- 12 Jun 2007
- Last updated
- 17 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Evaluation of Prolact-Plus, Human Milk Fortifier (Human, Pasteurized) for Pre-term Infants Receiving Human Milk
- ClinicalTrials.gov ID
- NCT00486590
- Acronym / sponsor ID
- MPPF 001-2006
- Conditions
- Infant, Very Low Birth Weight
- Keywords
- Human milk fortification, Premature neonate, Very low birth weight
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Prolacta BioscienceIndustry (pharma, biotech, devices)
- Study start
- Aug 2006
- Primary completion
- Aug 2007 (actual)
- Study completion
- Aug 2007 (actual)
- First posted
- 14 Jun 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This will be a cohort designed study in pre-term infants (<32 weeks of gestation) comparing bovine fortified (using any one of the commercially available fortifier products) human milk with Prolact-Plus (human) fortified human milk in which the former cohort will be obtained retrospectively and the latter obtained prospectively in each participating institution. The number of infants to be included in this study is a minimum of 50 in each group who complete the 30 days on study. (If a baby drops out of the study prior to 30 days of evaluation, then they would be replaced in order to achieve that number.) This sample size was not determined statistically, but rather is based solely on the desire to obtain a reasonable amount of data to evaluate the new human fortifier in this setting. However, from the perspective of a non-inferiority evaluation of an endpoint such as feeding intolerance, consider the following. Assuming a rate of 15% for this outcome for the retrospective cohort, then with 50 subjects per cohort, the study would be able to demonstrate a lack of inferiority of the human-based fortifier with a delta of 20% using a power of slightly greater than 80% and a one-sided 2.5% significance level. (By a "delta of 20%" it is implied that a theoretical feeding intolerance rate for the Prolact-Plus of no worse than 35% would result in a conclusion of lack of inferiority with the given levels of significance and power.) Conversely, if the human-based fortifier is able to reduce the feeding intolerance rate from 15% to about 1%, then with the sample sizes in this trial, this would be doable with 80% power and 5% significance (two-sided). (Thus, the trial, in theory, also could demonstrate a dramatic reduction in this rate.) The retrospective data will be obtained from available medical charts at the participating institution and the selected infants should reflect the most recently treated (within the 12 month period prior to the initiation of the prospective phase of this protocol) and the numbers should be similar in kind to the number treated prospectively in that institution.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 1 day to 30 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (3 listed)
- Less than a 50% probability of survival through the study period (first 30 days of enteral feeding or hospital discharge).
- On any other clinical study during the study period
- Receipt of any bovine-based formula or fortifier prior to the infant's enrollment in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prolact-Plus Human Milk Fortifier | Procedure or surgery | – |
Primary outcome
Feeding intolerance
Time frame: 30 days
Necrotizing enterocolitis
Time frame: 30 days
2 secondary outcomes
Length of stay in NICU and hospital
Time frame: Indeterminate
Growth parameters, e.g. weight, head circumference, and length
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martin L Lee, PhD study director
Prolacta Bioscience
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prolact-Plus Human Milk Fortifier in people with Infant, Very Low Birth Weight, run by Prolacta Bioscience at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feeding intolerance (time frame: 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2021.