Infant, Very Low Birth WeightNCT00506584
Randomized Study of Human-Milk Based Nutrition Versus Formula in Premature Infants
A study testing Pasteurized human milk and pasteurized human milk fortifier, Human milk fortifier (bovine-based), pre-term formula and Pre-term/term formula in people with Infant, Very Low Birth Weight, run by Prolacta Bioscience at 13 sites in 2 countries.
Trial summary
The purpose of this study is to determine whether very low birth weight infants (less than or equal to 1250g or about 2 3/4 pounds) born prematurely fed a diet of only human milk and human milk-derived nutrition have better health outcomes than babies fed at least some formula (made from cow's milk)or formula-derived… Read more about this study
- Who is it for?
- Ages 1 day to 21 days
- Conditions the study is for
- Infant, Very Low Birth Weight
- What is being tested?
- Pasteurized human milk and pasteurized human milk fortifier, Human milk fortifier (bovine-based), pre-term formula and Pre-term/term formula
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 260 participants
- Where
- 13 sitesin 2 countries
- Study dates
- Jul 2007to Jul 2008
- 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 21 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Birth weight between 500 and 1250g.
- Have a reasonable expectation of survival for the maximum 90 day duration of the study.
- In "Study Group 1", must be able to adhere to a feeding protocol involving mother's own milk and that may include donor human milk with fortification using a human-based product (Prolact+4) or fortification with a bovine-based human milk fortifier and the use of a pre-term/term formula; or in "Study Group 2" the use of donor human milk with Prolact+4 or a pre-term/term formula from the time that the infant initiates enteral feeding through day 90 of life, until discharge from the study institution, discharge home, death or the initiation of at least 50% total oral nutrition (4 complete feeds in a 24 hour period), whichever comes first.
- Enteral feeding must begin before the 21st day of life.
- Total parenteral nutrition (TPN) initiated within 48 hours after birth.
- Informed consent obtained from parent or legal guardian.
Who cannot join
- Less than a reasonable expectation of survival for the infant's particular gestational age through the study period (first 90 days of life, discharge to a non-study institution, discharge home, death or initiation of 50% oral nutrition, whichever comes first).
- On any other clinical study affecting nutritional management during the study period.
- Decision to not start minimum enteral feed before day 21 of life.
- Decision to not start TPN within the first 48 hours after birth.
- Unable to obtain informed consent from parent or legal guardian prior to the initiation of enteral feeding.
- Presence of clinically significant congenital heart disease.
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- Presence of any major congenital malformations.
- Reasonable potential for early transfer to a non-study institution.
- Unable to participate for any reason based on the decision of the study investigator.
Trial locations and contacts
13 sites in 2 countries.
13 sites in 2 countries
United States12 sites
Johns Hopkins Hospital
Baltimore, Maryland, 21287
Alta Bates Summit Medical Center
Berkeley, California, 94705
Rush-Presbyterian St. Luke's Medical Center
Chicago, Illinois, 60612
Duke University Medical Center
Durham, North Carolina, 27710
Shands Children's Hospital
Gainesville, Florida, 32610-0296
Ben Taub Hospital/Baylor College of Medicine
Houston, Texas, 77030
Schneider Children's Hospital at North Shore
Manhasset, New York, 11030
Yale University School of Medicine
New Haven, Connecticut, 06520
Strong Memorial Hospital
Rochester, New York, 14642
University of Utah Medical Center
Salt Lake City, Utah, 84132
University of Texas Health Science Center
San Antonio, Texas, 78229-3900
University of California, San Diego Medical Center
San Diego, California, 92103-8774
About this study
Official title: A Randomized Study of Human Milk-Based Versus Bovine-based Nutrition for Very Low Birth Weight Pre-Term Infants
The purpose of this study is to determine whether very low birth weight infants (less than or equal to 1250g or about 2 3/4 pounds) born prematurely fed a diet of only human milk and human milk-derived nutrition have better health outcomes than babies fed at least some formula (made from cow's milk)or formula-derived nutrition.
Read the detailed description
The goal of this study is to evaluate the short-term effect (up to 90 days of life) of purely human-based nutrition using mother's own milk (when available), donor milk preparations and a human-based fortifier (Prolact+4) as needed when compared with mother's own milk supplemented with pre-term formula and using a bovine-based HMF (as needed for fortification of mother's own milk), i.e. "Study Group 1"; or, when mother's milk is not available, comparing the use of donor milk (plus human milk based fortification) with pre-term/term formula, i.e. "Study Group 2". In both instances the comparison will be based on the primary endpoint of days of TPN, and on parameters such as time to full enteral feeding (approximately 150-160 mL/kg/day), amount of IV fluid support, culture-proven sepsis, NEC, death, growth and short-term development, cultured-proven sepsis and incidence of feeding intolerance in either a 2-arm (human nutrition versus bovine nutrition: "Study Group 2") or 3-arm randomized design (human fortifier given when feedings reach 40 mL/kg/day, human fortifier given when feedings reach 100 mL/kg/day, and bovine-based HMF given when feedings reach 100 mL/kg/day [or pre-term formula if mother's milk is not available]: "Study Group 1").
Statistically, the study will attempt to evaluate a null hypothesis of equivalent results with respect to these parameters between either the three types of fortifications in "Study Group 1" or the two types of overall nutrition in "Study Group 2", as compared with an alternative of some inequality between the groups, i.e. letting μ be the mean number of days of TPN any of the study arms, then for "Study Group 1 the hypotheses may be written as:
H0: μ control = μ human 40 = μhuman 100 and HA: At least two of μ control, μ human 40, and μhuman 100 are not equal, where "control" is the bovine-based HMF group, "human 40" is the human fortifier group starting at 40 mL/kg/day (arm 2) and "human 100" is the human fortifier group starting at 100 mL/kg/day (arm 1). For "Study Group 2", the competing hypotheses are: H0: μ formula = μ human and HA: μ formula ≠ μ human , where "formula" is the pre-term/term formula group and "human" is the human-based (donor milk/human-based fortifier) group.
In addition, data will be collected on overall survival and length of stay in the NICU. Any baby that does not complete the full study period will be right-censored in this regard for the purposes of data evaluation. For centers that obtain long-term follow up (18-24 months) on their patients, data on developmental outcomes will be evaluated as available.
- Conditions
- Infant, Very Low Birth Weight
- Being tested
- Pasteurized human milk and pasteurized human milk fortifier, Human milk fortifier (bovine-based), pre-term formula, Pre-term/term formula
- Keywords
- Human milk nutritional intervention, Pre-term, very low birth weight, Fortification of human breast milk
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pasteurized human milk and pasteurized human milk fortifierDietary supplement
Also called Prolact20/Neo20, Prolact+4
Human milk fortifier is initiated when nutrition volume reaches 100 mL/kg/day
Pasteurized human milk and pasteurized human milk fortifierDietary supplement
Also called Prolact20/Neo 20, Prolact+4
Human milk fortifier is initiated when nutrition volume reaches 40 mL/kg/day
Human milk fortifier (bovine-based), pre-term formulaDietary supplement
Bovine-based human milk fortifier is initiated when nutrition volume reaches 100 mL/kg/day
Pasteurized human milk and pasteurized human milk fortifierDietary supplement
Also called Prolact20/Neo20, Prolact+4
Human milk fortifier initiated when nutrition volume reaches 100 mL/kg/day
Pre-term/term formulaDietary supplement
Bovine milk-derived nutrition formulated for very low birth weight infants
| Study group | Role | What they receive |
|---|---|---|
| Group 1, arm 1 | Experimental | Human breast milk + Prolact20/Neo20 (as needed) + Prolact+4 (initiated when nutrition volume reaches 100 mL/kg/day, where Prolact20/Neo 20 are donor human milk formulations at 20 cal/oz, Prolact+4 is a human-milk derived human milk fortified designed to add 4 cal/oz to 20 cal/oz human breast milk. Receives: Dietary Supplement: Pasteurized human milk and pasteurized human milk fortifier |
| Group1, Arm 2 | Experimental | Human breast milk + Prolact20/Neo20 (as needed) + Prolact+4 (initiated when nutrition volume reaches 40 mL/kg/day), where Prolact20/Neo 20 are donor human milk formulations at 20 cal/oz, Prolact+4 is a human-milk derived human milk fortified designed to add 4 cal/oz to 20 cal/oz human breast milk. Receives: Dietary Supplement: Pasteurized human milk and pasteurized human milk fortifier |
| Group 1, Arm 3 | Active comparator | Human breast milk + bovine-based human milk fortifier (initiated when nutrition volume reaches 100 mL/kg/day) + pre-term formula (as needed) Receives: Dietary Supplement: Human milk fortifier (bovine-based), pre-term formula |
| Group 2, Arm 1 | Experimental | Prolact20/Neo20 + Prolact+4 (initiated when nutrition volume reaches 100 mL/kg/day), where Prolact20/Neo 20 are donor human milk formulations at 20 cal/oz, Prolact+4 is a human-milk derived human milk fortified designed to add 4 cal/oz to 20 cal/oz human breast milk. Receives: Dietary Supplement: Pasteurized human milk and pasteurized human milk fortifier |
| Group 2, Arm 2 | Active comparator | Pre-term/term formula (minimum 20 cal/oz) Receives: Dietary Supplement: Pre-term/term formula |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary measure of efficacy for the study is the number of days of TPN (total parenteral nutrition)
Measured: The first 90 days of life, discharge from the study institution or initiation of 50% oral nutrition (50% of the feeding volume in a given 24 hour period provided PO, or 4 complete PO feeds in a given 24 hour period), whichever comes first
Secondary outcomes (5)
Weight gain and other measures of growth including length and head circumference
Measured: The first 90 days of life, transfer to non-study institution, or initiation of 50% oral feeding, whichever comes first
Daily amount of all nutrition
Measured: The first 90 days of life, transfer to non-study institution, or initiation of 50% oral feeding, whichever comes first
Time to discharge from the NICU and hospital
Measured: The first 90 days of life, transfer to non-study institution, or initiation of 50% oral feeding, whichever comes first
Frequency of occurrence of late-onset sepsis and necrotizing enterocolitis
Measured: The first 90 days of life, transfer to non-study institution, or initiation of 50% oral feeding, whichever comes first
Frequency of feeding intolerance
Measured: The first 90 days of life, transfer to non-study institution, or initiation of 50% oral feeding, whichever comes first
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2007 (estimated)
- Study startJul 2007
- Primary completionJul 2008
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 260 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prolacta Bioscience
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Richard J Schanler, MD, Study chair, Schneider Children's Hospital at North Shore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00506584
- Sponsor's protocol ID
- MPPF 001-2007
- Status last verified
- Feb 2010
- First submitted
- 20 Jul 2007
- Last updated
- 18 Feb 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Sullivan S, Schanler RJ, Kim JH, Patel AL, Trawoger R, Kiechl-Kohlendorfer U, Chan GM, Blanco CL, Abrams S, Cotten CM, Laroia N, Ehrenkranz RA, Dudell G, Cristofalo EA, Meier P, Lee ML, Rechtman DJ, Lucas A. An exclusively human milk-based diet is associated with a lower rate of necrotizing enterocolitis than a diet of human milk and bovine milk-based products. J Pediatr. 2010 Apr;156(4):562-7.e1. doi: 10.1016/j.jpeds.2009.10.040. Epub 2009 Dec 29.
PubMed 20036378Quigley M, Embleton ND, Meader N, McGuire W. Donor human milk for preventing necrotising enterocolitis in very preterm or very low-birthweight infants. Cochrane Database Syst Rev. 2024 Sep 6;9(9):CD002971. doi: 10.1002/14651858.CD002971.pub6.
PubMed 39239939Cristofalo EA, Schanler RJ, Blanco CL, Sullivan S, Trawoeger R, Kiechl-Kohlendorfer U, Dudell G, Rechtman DJ, Lee ML, Lucas A, Abrams S. Randomized trial of exclusive human milk versus preterm formula diets in extremely premature infants. J Pediatr. 2013 Dec;163(6):1592-1595.e1. doi: 10.1016/j.jpeds.2013.07.011. Epub 2013 Aug 20.
PubMed 23968744Ghandehari H, Lee ML, Rechtman DJ; H2MF Study Group. An exclusive human milk-based diet in extremely premature infants reduces the probability of remaining on total parenteral nutrition: a reanalysis of the data. BMC Res Notes. 2012 Apr 25;5:188. doi: 10.1186/1756-0500-5-188.
PubMed 22534258
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Study of Human Milk-Based Versus Bovine-based Nutrition for Very Low Birth Weight Pre-Term Infants
- ClinicalTrials.gov ID
- NCT00506584
- Acronym / sponsor ID
- MPPF 001-2007
- Conditions
- Infant, Very Low Birth Weight
- Keywords
- Human milk nutritional intervention, Pre-term, very low birth weight, Fortification of human breast milk
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 260 participants (actual)
- Lead sponsor
- Prolacta BioscienceIndustry (pharma, biotech, devices)
- Study start
- Jul 2007
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 25 Jul 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.
The purpose of this study is to determine whether very low birth weight infants (less than or equal to 1250g or about 2 3/4 pounds) born prematurely fed a diet of only human milk and human milk-derived nutrition have better health outcomes than babies fed at least some formula (made from cow's milk)or formula-derived nutrition.
Detailed description
The goal of this study is to evaluate the short-term effect (up to 90 days of life) of purely human-based nutrition using mother's own milk (when available), donor milk preparations and a human-based fortifier (Prolact+4) as needed when compared with mother's own milk supplemented with pre-term formula and using a bovine-based HMF (as needed for fortification of mother's own milk), i.e. "Study Group 1"; or, when mother's milk is not available, comparing the use of donor milk (plus human milk based fortification) with pre-term/term formula, i.e. "Study Group 2". In both instances the comparison will be based on the primary endpoint of days of TPN, and on parameters such as time to full enteral feeding (approximately 150-160 mL/kg/day), amount of IV fluid support, culture-proven sepsis, NEC, death, growth and short-term development, cultured-proven sepsis and incidence of feeding intolerance in either a 2-arm (human nutrition versus bovine nutrition: "Study Group 2") or 3-arm randomized design (human fortifier given when feedings reach 40 mL/kg/day, human fortifier given when feedings reach 100 mL/kg/day, and bovine-based HMF given when feedings reach 100 mL/kg/day [or pre-term formula if mother's milk is not available]: "Study Group 1").
Statistically, the study will attempt to evaluate a null hypothesis of equivalent results with respect to these parameters between either the three types of fortifications in "Study Group 1" or the two types of overall nutrition in "Study Group 2", as compared with an alternative of some inequality between the groups, i.e. letting μ be the mean number of days of TPN any of the study arms, then for "Study Group 1 the hypotheses may be written as:
H0: μ control = μ human 40 = μhuman 100 and HA: At least two of μ control, μ human 40, and μhuman 100 are not equal, where "control" is the bovine-based HMF group, "human 40" is the human fortifier group starting at 40 mL/kg/day (arm 2) and "human 100" is the human fortifier group starting at 100 mL/kg/day (arm 1). For "Study Group 2", the competing hypotheses are: H0: μ formula = μ human and HA: μ formula ≠ μ human , where "formula" is the pre-term/term formula group and "human" is the human-based (donor milk/human-based fortifier) group.
In addition, data will be collected on overall survival and length of stay in the NICU. Any baby that does not complete the full study period will be right-censored in this regard for the purposes of data evaluation. For centers that obtain long-term follow up (18-24 months) on their patients, data on developmental outcomes will be evaluated as available.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Group 1, arm 1 | Experimental | Dietary Supplement: Pasteurized human milk and pasteurized human milk fortifierHuman breast milk + Prolact20/Neo20 (as needed) + Prolact+4 (initiated when nutrition volume reaches 100 mL/kg/day, where Prolact20/Neo 20 are donor human milk formulations at 20 cal/oz, Prolact+4 is a human-milk derived human milk fortified designed to add 4 cal/oz to 20 cal/oz human breast milk. |
| Group1, Arm 2 | Experimental | Dietary Supplement: Pasteurized human milk and pasteurized human milk fortifierHuman breast milk + Prolact20/Neo20 (as needed) + Prolact+4 (initiated when nutrition volume reaches 40 mL/kg/day), where Prolact20/Neo 20 are donor human milk formulations at 20 cal/oz, Prolact+4 is a human-milk derived human milk fortified designed to add 4 cal/oz to 20 cal/oz human breast milk. |
| Group 1, Arm 3 | Active comparator | Dietary Supplement: Human milk fortifier (bovine-based), pre-term formulaHuman breast milk + bovine-based human milk fortifier (initiated when nutrition volume reaches 100 mL/kg/day) + pre-term formula (as needed) |
| Group 2, Arm 1 | Experimental | Dietary Supplement: Pasteurized human milk and pasteurized human milk fortifierProlact20/Neo20 + Prolact+4 (initiated when nutrition volume reaches 100 mL/kg/day), where Prolact20/Neo 20 are donor human milk formulations at 20 cal/oz, Prolact+4 is a human-milk derived human milk fortified designed to add 4 cal/oz to 20 cal/oz human breast milk. |
| Group 2, Arm 2 | Active comparator | Dietary Supplement: Pre-term/term formulaPre-term/term formula (minimum 20 cal/oz) |
Who may qualify
- Ages
- 1 day to 21 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Birth weight between 500 and 1250g.
- Have a reasonable expectation of survival for the maximum 90 day duration of the study.
- In "Study Group 1", must be able to adhere to a feeding protocol involving mother's own milk and that may include donor human milk with fortification using a human-based product (Prolact+4) or fortification with a bovine-based human milk fortifier and the use of a pre-term/term formula; or in "Study Group 2" the use of donor human milk with Prolact+4 or a pre-term/term formula from the time that the infant initiates enteral feeding through day 90 of life, until discharge from the study institution, discharge home, death or the initiation of at least 50% total oral nutrition (4 complete feeds in a 24 hour period), whichever comes first.
- Enteral feeding must begin before the 21st day of life.
- Total parenteral nutrition (TPN) initiated within 48 hours after birth.
Key exclusion criteria (9 listed)
- Less than a reasonable expectation of survival for the infant's particular gestational age through the study period (first 90 days of life, discharge to a non-study institution, discharge home, death or initiation of 50% oral nutrition, whichever comes first).
- On any other clinical study affecting nutritional management during the study period.
- Decision to not start minimum enteral feed before day 21 of life.
- Decision to not start TPN within the first 48 hours after birth.
- Unable to obtain informed consent from parent or legal guardian prior to the initiation of enteral feeding.
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 |
|---|---|---|
| Pasteurized human milk and pasteurized human milk fortifierAlso: Prolact20/Neo20, Prolact+4Human milk fortifier is initiated when nutrition volume reaches 100 mL/kg/day | Dietary supplement | Group 1, arm 1 |
| Pasteurized human milk and pasteurized human milk fortifierAlso: Prolact20/Neo 20, Prolact+4Human milk fortifier is initiated when nutrition volume reaches 40 mL/kg/day | Dietary supplement | Group1, Arm 2 |
| Human milk fortifier (bovine-based), pre-term formulaBovine-based human milk fortifier is initiated when nutrition volume reaches 100 mL/kg/day | Dietary supplement | Group 1, Arm 3 |
| Pasteurized human milk and pasteurized human milk fortifierAlso: Prolact20/Neo20, Prolact+4Human milk fortifier initiated when nutrition volume reaches 100 mL/kg/day | Dietary supplement | Group 2, Arm 1 |
| Pre-term/term formulaBovine milk-derived nutrition formulated for very low birth weight infants | Dietary supplement | Group 2, Arm 2 |
Primary outcome
The primary measure of efficacy for the study is the number of days of TPN (total parenteral nutrition)
Time frame: The first 90 days of life, discharge from the study institution or initiation of 50% oral nutrition (50% of the feeding volume in a given 24 hour period provided PO, or 4 complete PO feeds in a given 24 hour period), whichever comes first
5 secondary outcomes
Weight gain and other measures of growth including length and head circumference
Time frame: The first 90 days of life, transfer to non-study institution, or initiation of 50% oral feeding, whichever comes first
Daily amount of all nutrition
Time frame: The first 90 days of life, transfer to non-study institution, or initiation of 50% oral feeding, whichever comes first
Time to discharge from the NICU and hospital
Time frame: The first 90 days of life, transfer to non-study institution, or initiation of 50% oral feeding, whichever comes first
Frequency of occurrence of late-onset sepsis and necrotizing enterocolitis
Time frame: The first 90 days of life, transfer to non-study institution, or initiation of 50% oral feeding, whichever comes first
Frequency of feeding intolerance
Time frame: The first 90 days of life, transfer to non-study institution, or initiation of 50% oral feeding, whichever comes first
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 18 Feb 2010.
- Results publication: PubMed 20036378Sullivan S, Schanler RJ, Kim JH, Patel AL, Trawoger R, Kiechl-Kohlendorfer U, Chan GM, Blanco CL, Abrams S, Cotten CM, Laroia N, Ehrenkranz RA, Dudell G, Cristofalo EA, Meier P, Lee ML, Rechtman DJ, Lucas A. An exclusively human milk-based diet is associated with a lower rate of necrotizing enterocolitis than a diet of human milk and bovine milk-based products. J Pediatr. 2010 Apr;156(4):562-7.e1. doi: 10.1016/j.jpeds.2009.10.040. Epub 2009 Dec 29.
- Derived from this study: PubMed 39239939Quigley M, Embleton ND, Meader N, McGuire W. Donor human milk for preventing necrotising enterocolitis in very preterm or very low-birthweight infants. Cochrane Database Syst Rev. 2024 Sep 6;9(9):CD002971. doi: 10.1002/14651858.CD002971.pub6.
- Derived from this study: PubMed 23968744Cristofalo EA, Schanler RJ, Blanco CL, Sullivan S, Trawoeger R, Kiechl-Kohlendorfer U, Dudell G, Rechtman DJ, Lee ML, Lucas A, Abrams S. Randomized trial of exclusive human milk versus preterm formula diets in extremely premature infants. J Pediatr. 2013 Dec;163(6):1592-1595.e1. doi: 10.1016/j.jpeds.2013.07.011. Epub 2013 Aug 20.
- Derived from this study: PubMed 22534258Ghandehari H, Lee ML, Rechtman DJ; H2MF Study Group. An exclusive human milk-based diet in extremely premature infants reduces the probability of remaining on total parenteral nutrition: a reanalysis of the data. BMC Res Notes. 2012 Apr 25;5:188. doi: 10.1186/1756-0500-5-188.
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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.
Richard J Schanler, MD study chair
Schneider Children's Hospital at North Shore
13 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pasteurized human milk and pasteurized human milk fortifier, Human milk fortifier (bovine-based), pre-term formula and Pre-term/term formula in people with Infant, Very Low Birth Weight, run by Prolacta Bioscience at 13 sites in 2 countries.
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 9 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 18 Feb 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States, Austria. 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?
The primary measure of efficacy for the study is the number of days of TPN (total parenteral nutrition) (time frame: The first 90 days of life, discharge from the study institution or initiation of 50% oral nutrition (50% of the feeding volume in a given 24 hour period provided PO, or 4 complete PO feeds in a given 24 hour period), whichever comes first). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00506584, which also lists 4 linked publications.
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 18 Feb 2010.