PrematurityNCT01487928
Human Milk Cream as a Caloric Supplement in Pre-Term Infants
A study testing Human Milk Cream in people with Prematurity, run by Baylor College of Medicine at 2 sites in United States.
Trial summary
Human milk is commonly considered to have 20 calories per ounce (kcal/oz). However, studies show that up to 65% of human milk may be less than the expected 20 kcal/oz which can greatly affect an infant's growth. Read more about this study
- Who is it for?
- Ages Up to 21 days
- Conditions the study is for
- Prematurity
- What is being tested?
- Human Milk Cream
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 2 sitesUnited States
- Study dates
- Dec 2011to Jun 2015
- 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 Up to 21 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Birth weight 750 - 1250g
- Able to adhere to expected feeding protocol of mother's own milk/donor milk with fortification of Prolacta® fortifier
- Reasonable expectation of survival
- Enteral feeding must begin before the 21st day of life
Who cannot join
- Decision to not start minimum enteral feed before day 21 of life
- Unable to obtain informed consent from parent/guardian prior to the initiation of fortification of enteral feeding
- Enrolled in any other clinical study affecting nutritional management during the study period
- Presence of clinically significant congenital heart disease or major congenital malformations
- Reasonable potential for early transfer to a non-study institution
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Baylor College of Medicine / Texas Children's Hospital
Houston, Texas, 77030
UT Health Science Center, San Antonio
San Antonio, Texas, 78229
About this study
Official title: A Randomized Study of the Use of Human Milk Cream as a Caloric Supplement in a Subset of Very Low Birth Weight Pre-Term Infants
Human milk is commonly considered to have 20 calories per ounce (kcal/oz). However, studies show that up to 65% of human milk may be less than the expected 20 kcal/oz which can greatly affect an infant's growth. The investigators now have the ability to measure caloric density of human milk and add human milk cream to any human milk (mother's own or donor human milk) that is less than 20 kcal/oz to bring it up to that amount.
Read the detailed description
Once fortification (to either mother's or donor milk) is initiated and tolerance is established (based on clinical observation), infants will be randomized into one of two groups: to receive human milk cream or not.
- Human Milk Cream Group: Human milk (either mother's own or donor) will be tested (once per container of milk). If the caloric level falls below 20 kcal/oz, then an appropriate amount of human milk cream will be added to the milk to bring the content as close as possible to 20 kcal/oz.
- Control Group (no human milk cream): Milk (either mother's own or donor) and human milk fortifier will be provided as usual (milk will be analyzed for study purposes).
This nutritional algorithm will continue until the infant reaches 36 weeks corrected gestational age/weaned from fortifier (whichever comes first) or is otherwise removed from the study (due to transfer to non-study institution, removal from the study or death).
Data will be collected from the time of study entry until the infant reaches 36 weeks corrected gestational age or weaned from the fortifier (whichever comes first) or is otherwise removed from the study.
Primary measure of efficacy:
The primary measure of efficacy for the study is the rate of change of weight from the initiation of enteral feeding through 36 weeks corrected gestational age or weaned from fortifier, whichever comes first. Based on an intent-to-treat (ITT) paradigm, if a study subject fails to complete the study period for any reason, this rate will be determined for the period of time on study. In order to provide a valid comparison between the study subjects, the rate of weight gain will be reported as g/kg/day. In a per-protocol analysis, these subjects will be dropped from any calculations with respect to this primary endpoint.
Primary measure of safety:
For the evaluation of safety, any untoward effects deemed to be related to the nutritional regimen will be identified and recorded. Key outcomes in this regard include feeding intolerance, necrotizing enterocolitis (NEC) and sepsis. Because this population has a high associated morbidity, episodes of apnea, and the use of oxygen and ventilators will be evaluated from a safety perspective.
Baseline measures: (study entry, i.e. initiation of enteral feeding)
At study entry, the following variables will be recorded: birth weight, gestational age, gender, Apgar score at 5 minutes, use of mechanical ventilation at study entry, use of prenatal or postnatal steroids, and the age in days at which enteral feeding was initiated. In addition the presence of any of the following clinical conditions either at the time of study entry or occurring during the course of the study will be noted: transient tachypnea of newborn (TTN), intraventricular hemorrhage (IVH) and grade, and patent ductus arteriosis (PDA).
Other growth measures:
Head circumference increment for the study period and length increment for the study period will be determined (and recorded as cm/week). Length and head circumference will be recorded on a weekly basis during the study period. The use of medications that influence growth and development will be recorded. These include postnatal steroids, e.g. hydrocortisone and dexamethasone, caffeine and other methylxanthine preparations.
Feeding protocol:
The daily amount of all enteral nutrition will be recorded in units of mL. This quantity will be subdivided into the various types of nutrition used, i.e. mother's milk, donor milk, human milk cream, fortifiers, and any other nutritional support. In the event of feeding intolerance or discontinuation of enteral feeding and the baby being returned to total parenteral nutrition (TPN), the assumed cause will be identified. The total number of days of TPN will be recorded for the study period as well as the range of dates the infant was on TPN.
Infectious complications:
Although not a focus of this study, occurrences of sepsis, NEC and other related infectious outcomes will be recorded.
Demographics:
Basic demographic and medical information on each subject will be collected and recorded. These variables include: gestational age, birth weight (including whether the infant was AGA or SGA based on standard criteria), gender, and racial group.
Medications:
Information on the dosing of the following drugs will be recorded: Lasix, caffeine, diuril, insulin, and dopamine.
Parenteral Nutrition:
Components and rate of parenteral nutrition will be recorded during study days to further evaluate nutritional intake and growth.
Labs:
Nutritionally-relevant labs that are obtained for clinical purposes will be recorded: Na, K, Cl, CO2, BUN, Creatinine, glucose, Ca, Phos, Mg, and triglycerides.
- Conditions
- Prematurity
- Being tested
- Human Milk Cream
- Keywords
- breastfed, human milk cream, human milk fat, caloric supplement
- Medical subject headings
- Premature Birth, Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Human Milk CreamDietary supplement
If the caloric level of human milk (mother's own or donor) falls below 20 kcal/oz, then an appropriate amount of human milk cream will be added to the milk to bring the content as close as possible to 20 kcal/oz. For example, if the human milk is 19 kcal/oz, 2 mL of human milk cream will be added to 100mL of human milk.
| Study group | Role | What they receive |
|---|---|---|
| Human Milk Cream Group | Experimental | For infants randomized to the human milk cream group, the human milk (either mother's own or donor) being provided to the infant will be tested each time a new container is used to prepare feedings. The test will be for the caloric content of the milk using a commercially available device provided for this purpose. If the caloric level falls below 20 kcal/oz for any test, then an appropriate amount of human milk cream will be added to the milk to bring the content as close as possible to 20 kcal/oz. The amount added will be calculated to the nearest mL rounding down for 0.1-0.4mL and up for 0.5-0.9 mL to avoid imprecision due to the measuring device used in the nutrition preparation area. Receives: Dietary Supplement: Human Milk Cream |
| Control Group | No intervention | For infants randomized to the Control group, human milk and human milk derived fortifier will be provided according to the institutional standard of care and there will be no use of the milk analysis (mother's own or donor), which is typical for the vast majority of neonatal intensive care units. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Caloric content of human milk
Human milk samples will be analyzed for macronutrients and total caloric content.
Measured: Daily until 36 weeks corrected gestational age
Secondary outcomes (1)
Growth
Growth (weight, length, and head circumference) will be evaluated weekly throughout the study
Measured: Weekly until 36 weeks corrected age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2011 (estimated)
- Study startDec 2011
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for PrematurityStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Prolacta Bioscience
- Responsible party
- Principal investigator, Amy Hair, Baylor College of Medicine
- Investigators
- Amy B Hair, MD, Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01487928
- Sponsor's protocol ID
- H-29743
- Status last verified
- Jan 2026
- First submitted
- 5 Dec 2011
- Last updated
- 29 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
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 20036378Wojcik KY, Rechtman DJ, Lee ML, Montoya A, Medo ET. Macronutrient analysis of a nationwide sample of donor breast milk. J Am Diet Assoc. 2009 Jan;109(1):137-40. doi: 10.1016/j.jada.2008.10.008.
PubMed 19103335Hawthorne KM, Griffin IJ, Abrams SA. Current issues in nutritional management of very low birth weight infants. Minerva Pediatr. 2004 Aug;56(4):359-72.
PubMed 15457134Fabrizio V, Trzaski JM, Brownell EA, Esposito P, Lainwala S, Lussier MM, Hagadorn JI. Individualized versus standard diet fortification for growth and development in preterm infants receiving human milk. Cochrane Database Syst Rev. 2020 Nov 23;11(11):CD013465. doi: 10.1002/14651858.CD013465.pub2.
PubMed 33226632Amissah EA, Brown J, Harding JE. Protein supplementation of human milk for promoting growth in preterm infants. Cochrane Database Syst Rev. 2020 Sep 23;9(9):CD000433. doi: 10.1002/14651858.CD000433.pub3.
PubMed 32964431Hair AB, Blanco CL, Moreira AG, Hawthorne KM, Lee ML, Rechtman DJ, Abrams SA. Randomized trial of human milk cream as a supplement to standard fortification of an exclusive human milk-based diet in infants 750-1250 g birth weight. J Pediatr. 2014 Nov;165(5):915-20. doi: 10.1016/j.jpeds.2014.07.005. Epub 2014 Aug 15.
PubMed 25130571
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Study of the Use of Human Milk Cream as a Caloric Supplement in a Subset of Very Low Birth Weight Pre-Term Infants
- ClinicalTrials.gov ID
- NCT01487928
- Acronym / sponsor ID
- H-29743
- Conditions
- Prematurity
- Keywords
- breastfed, human milk cream, human milk fat, caloric supplement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Collaborators
- Prolacta Bioscience
- Study start
- Dec 2011
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 8 Dec 2011 (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.
Human milk is commonly considered to have 20 calories per ounce (kcal/oz). However, studies show that up to 65% of human milk may be less than the expected 20 kcal/oz which can greatly affect an infant's growth. The investigators now have the ability to measure caloric density of human milk and add human milk cream to any human milk (mother's own or donor human milk) that is less than 20 kcal/oz to bring it up to that amount.
Detailed description
Once fortification (to either mother's or donor milk) is initiated and tolerance is established (based on clinical observation), infants will be randomized into one of two groups: to receive human milk cream or not.
- Human Milk Cream Group: Human milk (either mother's own or donor) will be tested (once per container of milk). If the caloric level falls below 20 kcal/oz, then an appropriate amount of human milk cream will be added to the milk to bring the content as close as possible to 20 kcal/oz.
- Control Group (no human milk cream): Milk (either mother's own or donor) and human milk fortifier will be provided as usual (milk will be analyzed for study purposes).
This nutritional algorithm will continue until the infant reaches 36 weeks corrected gestational age/weaned from fortifier (whichever comes first) or is otherwise removed from the study (due to transfer to non-study institution, removal from the study or death).
Data will be collected from the time of study entry until the infant reaches 36 weeks corrected gestational age or weaned from the fortifier (whichever comes first) or is otherwise removed from the study.
Primary measure of efficacy:
The primary measure of efficacy for the study is the rate of change of weight from the initiation of enteral feeding through 36 weeks corrected gestational age or weaned from fortifier, whichever comes first. Based on an intent-to-treat (ITT) paradigm, if a study subject fails to complete the study period for any reason, this rate will be determined for the period of time on study. In order to provide a valid comparison between the study subjects, the rate of weight gain will be reported as g/kg/day. In a per-protocol analysis, these subjects will be dropped from any calculations with respect to this primary endpoint.
Primary measure of safety:
For the evaluation of safety, any untoward effects deemed to be related to the nutritional regimen will be identified and recorded. Key outcomes in this regard include feeding intolerance, necrotizing enterocolitis (NEC) and sepsis. Because this population has a high associated morbidity, episodes of apnea, and the use of oxygen and ventilators will be evaluated from a safety perspective.
Baseline measures: (study entry, i.e. initiation of enteral feeding)
At study entry, the following variables will be recorded: birth weight, gestational age, gender, Apgar score at 5 minutes, use of mechanical ventilation at study entry, use of prenatal or postnatal steroids, and the age in days at which enteral feeding was initiated. In addition the presence of any of the following clinical conditions either at the time of study entry or occurring during the course of the study will be noted: transient tachypnea of newborn (TTN), intraventricular hemorrhage (IVH) and grade, and patent ductus arteriosis (PDA).
Other growth measures:
Head circumference increment for the study period and length increment for the study period will be determined (and recorded as cm/week). Length and head circumference will be recorded on a weekly basis during the study period. The use of medications that influence growth and development will be recorded. These include postnatal steroids, e.g. hydrocortisone and dexamethasone, caffeine and other methylxanthine preparations.
Feeding protocol:
The daily amount of all enteral nutrition will be recorded in units of mL. This quantity will be subdivided into the various types of nutrition used, i.e. mother's milk, donor milk, human milk cream, fortifiers, and any other nutritional support. In the event of feeding intolerance or discontinuation of enteral feeding and the baby being returned to total parenteral nutrition (TPN), the assumed cause will be identified. The total number of days of TPN will be recorded for the study period as well as the range of dates the infant was on TPN.
Infectious complications:
Although not a focus of this study, occurrences of sepsis, NEC and other related infectious outcomes will be recorded.
Demographics:
Basic demographic and medical information on each subject will be collected and recorded. These variables include: gestational age, birth weight (including whether the infant was AGA or SGA based on standard criteria), gender, and racial group.
Medications:
Information on the dosing of the following drugs will be recorded: Lasix, caffeine, diuril, insulin, and dopamine.
Parenteral Nutrition:
Components and rate of parenteral nutrition will be recorded during study days to further evaluate nutritional intake and growth.
Labs:
Nutritionally-relevant labs that are obtained for clinical purposes will be recorded: Na, K, Cl, CO2, BUN, Creatinine, glucose, Ca, Phos, Mg, and triglycerides.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Human Milk Cream Group | Experimental | Dietary Supplement: Human Milk CreamFor infants randomized to the human milk cream group, the human milk (either mother's own or donor) being provided to the infant will be tested each time a new container is used to prepare feedings. The test will be for the caloric content of the milk using a commercially available device provided for this purpose. If the caloric level falls below 20 kcal/oz for any test, then an appropriate amount of human milk cream will be added to the milk to bring the content as close as possible to 20 kcal/oz. The amount added will be calculated to the nearest mL rounding down for 0.1-0.4mL and up for 0.5-0.9 mL to avoid imprecision due to the measuring device used in the nutrition preparation area. |
| Control Group | No intervention | –For infants randomized to the Control group, human milk and human milk derived fortifier will be provided according to the institutional standard of care and there will be no use of the milk analysis (mother's own or donor), which is typical for the vast majority of neonatal intensive care units. |
Who may qualify
- Ages
- Up to 21 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Birth weight 750 - 1250g
- Able to adhere to expected feeding protocol of mother's own milk/donor milk with fortification of Prolacta® fortifier
- Reasonable expectation of survival
- Enteral feeding must begin before the 21st day of life
Key exclusion criteria (5 listed)
- Decision to not start minimum enteral feed before day 21 of life
- Unable to obtain informed consent from parent/guardian prior to the initiation of fortification of enteral feeding
- Enrolled in any other clinical study affecting nutritional management during the study period
- Presence of clinically significant congenital heart disease or major congenital malformations
- Reasonable potential for early transfer to a non-study institution
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 |
|---|---|---|
| Human Milk CreamIf the caloric level of human milk (mother's own or donor) falls below 20 kcal/oz, then an appropriate amount of human milk cream will be added to the milk to bring the content as close as possible to 20 kcal/oz. For example, if the human milk is 19 kcal/oz, 2 mL of human milk cream will be added to 100mL of human milk. | Dietary supplement | Human Milk Cream Group |
Primary outcome
Caloric content of human milk
Time frame: Daily until 36 weeks corrected gestational age
Human milk samples will be analyzed for macronutrients and total caloric content.
1 secondary outcome
Growth
Time frame: Weekly until 36 weeks corrected age
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 29 Jan 2026.
- Background: 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.
- Background: PubMed 19103335Wojcik KY, Rechtman DJ, Lee ML, Montoya A, Medo ET. Macronutrient analysis of a nationwide sample of donor breast milk. J Am Diet Assoc. 2009 Jan;109(1):137-40. doi: 10.1016/j.jada.2008.10.008.
- Background: PubMed 15457134Hawthorne KM, Griffin IJ, Abrams SA. Current issues in nutritional management of very low birth weight infants. Minerva Pediatr. 2004 Aug;56(4):359-72.
- Derived from this study: PubMed 33226632Fabrizio V, Trzaski JM, Brownell EA, Esposito P, Lainwala S, Lussier MM, Hagadorn JI. Individualized versus standard diet fortification for growth and development in preterm infants receiving human milk. Cochrane Database Syst Rev. 2020 Nov 23;11(11):CD013465. doi: 10.1002/14651858.CD013465.pub2.
- Derived from this study: PubMed 32964431Amissah EA, Brown J, Harding JE. Protein supplementation of human milk for promoting growth in preterm infants. Cochrane Database Syst Rev. 2020 Sep 23;9(9):CD000433. doi: 10.1002/14651858.CD000433.pub3.
- Derived from this study: PubMed 25130571Hair AB, Blanco CL, Moreira AG, Hawthorne KM, Lee ML, Rechtman DJ, Abrams SA. Randomized trial of human milk cream as a supplement to standard fortification of an exclusive human milk-based diet in infants 750-1250 g birth weight. J Pediatr. 2014 Nov;165(5):915-20. doi: 10.1016/j.jpeds.2014.07.005. Epub 2014 Aug 15.
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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.
Amy B Hair, MD principal investigator
Baylor College of Medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Human Milk Cream in people with Prematurity, run by Baylor College of Medicine at 2 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 4 inclusion and 5 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 29 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Caloric content of human milk (time frame: Daily until 36 weeks corrected gestational age). 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 NCT01487928, which also lists 6 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 29 Jan 2026.