Breast Milk CollectionDOMENCT05742815
Analysis of Donor Milk
An observational study of Breast Milk Collection and Nutrition Disorder, Infant, run by Augusta University at 1 site in United States.
Trial summary
The purpose of this prospective, cross-sectional, observational study is to measure the nutrient composition of donated human breastmilk purchased from commercial human milk banks in North America Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Breast Milk Collection, Nutrition Disorder, Infant
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2022to 31 Dec 2023
- Phase
- Observational
- 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 Any age
- All sexes
- Child, Adult, Older adult
Study population: Donor milk samples will be collected from commercially available donor milk banks
Who may be able to join
- Donor human milk from commercially available milk banks
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Nationwide Sampling of Donor Human Milk Nutrient Content
The purpose of this prospective, cross-sectional, observational study is to measure the nutrient composition of donated human breastmilk purchased from commercial human milk banks in North America
Read the detailed description
Aim 1: To measure the micronutrient, macronutrients, microbial count, and endotoxins present in donated human breastmilk purchased from commercial human milk banks in North America (Table 2).
Aim 2: To compare the results of the nutrient analysis to nutrient recommendations for premature infants. (Table 3).
Aim 3: To use the results of the nutrient analysis to calculate the final nutrient content of donor human milk after the addition of commonly used human milk fortifiers (HMF). We will compare the calculated nutrients with intake recommendations for premature infants.
Background Preterm infants are at risk for nutrition depletion because of inadequate placental transfer, low volume feedings in the first days of life, and increased nutrient needs.1-3 Adequate intake of nutrients during neonatal development is crucial for growth. In addition, preterm infants are vulnerable to feeding-related complications, including necrotizing enterocolitis (NEC) and enteral feeding intolerance.4,5 Human milk feedings reduce the risk of NEC and enteral feeding intolerance and are considered the standard of feeding for this population. When mother's own milk (MOM) is not available or is inadequate to meet the needs of the infant, donor human milk (DHM) is the recommended feeding choice for preterm infants with birth weights ≤1500 grams.5 Several factors influence the nutrient composition of human milk, including lactation stage, gestational age at delivery, maternal age, body mass index (BMI), diet, and race.6-8 Preterm MOM is more nutrient-dense than mature human milk and continues to change as the lactation stage progresses.6,7,9 Donors of human milk are typically mothers of infants born at term and are unlikely to donate milk in the first month after delivery when milk is most nutrient-dense.
In 2011 22% of American neonatal intensive care units (NICU) used DHM to feed preterm infants. By 2017 the number of NICU purchasing DHM increased to 75%.10 To meet the demand for DHM, the number of human milk banks has increased from two in 1985 to more than thirty in 2020. The human milk banking industry is self-regulated with little oversight from governmental agencies. Donor human milk can be purchased from non-for-profit, private, public-benefits companies, or mother's milk co-operatives. Practices for donor selection, milk pooling, pasteurization or sterilization, nutrient analysis, and labeling vary by bank.11 Most DHM banks in North America do not report the nutrient composition of the DHM they sell. Of those that do, only three report nutrients other than protein, energy, and fat. Understanding the nutrient profiles of DHM is essential for creating feeding plans to meet the needs of preterm infants.
- Conditions
- Breast Milk Collection, Nutrition Disorder, Infant
- Being tested
- No intervention
- Medical subject headings
- Breast Milk Expression, Infant Nutrition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
This is an observational collection of data from purchased donor milk samples
What is being measured
The primary outcome is the main question the study is designed to answer.
Nutrient composition of donor human milk samples
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2023
- Study start1 Aug 2022
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Breast Milk CollectionStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Augusta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amy Gates, Augusta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05742815
- Sponsor's protocol ID
- 1823198-1
- Acronym
- DOME
- Status last verified
- Feb 2023
- First submitted
- 15 Feb 2023
- Last updated
- 24 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gates A, Maria SD, Meredith NA, Houslay T, Stansfield BK. Vitamin A in donor human milk: An experimental study. JPEN J Parenter Enteral Nutr. 2025 Nov;49(8):951-954. doi: 10.1002/jpen.70008. Epub 2025 Aug 20.
PubMed 40836482Gates A, Hair AB, Salas AA, Thompson AB, Stansfield BK. Nutrient Composition of Donor Human Milk and Comparisons to Preterm Human Milk. J Nutr. 2023 Sep;153(9):2622-2630. doi: 10.1016/j.tjnut.2023.07.012. Epub 2023 Jul 28.
PubMed 37517552
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nationwide Sampling of Donor Human Milk Nutrient Content
- ClinicalTrials.gov ID
- NCT05742815
- Acronym / sponsor ID
- DOME / 1823198-1
- Conditions
- Breast Milk Collection, Nutrition Disorder, Infant
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Augusta UniversityUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 24 Feb 2023 (actual)
- 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 prospective, cross-sectional, observational study is to measure the nutrient composition of donated human breastmilk purchased from commercial human milk banks in North America
Detailed description
Aim 1: To measure the micronutrient, macronutrients, microbial count, and endotoxins present in donated human breastmilk purchased from commercial human milk banks in North America (Table 2).
Aim 2: To compare the results of the nutrient analysis to nutrient recommendations for premature infants. (Table 3).
Aim 3: To use the results of the nutrient analysis to calculate the final nutrient content of donor human milk after the addition of commonly used human milk fortifiers (HMF). We will compare the calculated nutrients with intake recommendations for premature infants.
Background Preterm infants are at risk for nutrition depletion because of inadequate placental transfer, low volume feedings in the first days of life, and increased nutrient needs.1-3 Adequate intake of nutrients during neonatal development is crucial for growth. In addition, preterm infants are vulnerable to feeding-related complications, including necrotizing enterocolitis (NEC) and enteral feeding intolerance.4,5 Human milk feedings reduce the risk of NEC and enteral feeding intolerance and are considered the standard of feeding for this population. When mother's own milk (MOM) is not available or is inadequate to meet the needs of the infant, donor human milk (DHM) is the recommended feeding choice for preterm infants with birth weights ≤1500 grams.5 Several factors influence the nutrient composition of human milk, including lactation stage, gestational age at delivery, maternal age, body mass index (BMI), diet, and race.6-8 Preterm MOM is more nutrient-dense than mature human milk and continues to change as the lactation stage progresses.6,7,9 Donors of human milk are typically mothers of infants born at term and are unlikely to donate milk in the first month after delivery when milk is most nutrient-dense.
In 2011 22% of American neonatal intensive care units (NICU) used DHM to feed preterm infants. By 2017 the number of NICU purchasing DHM increased to 75%.10 To meet the demand for DHM, the number of human milk banks has increased from two in 1985 to more than thirty in 2020. The human milk banking industry is self-regulated with little oversight from governmental agencies. Donor human milk can be purchased from non-for-profit, private, public-benefits companies, or mother's milk co-operatives. Practices for donor selection, milk pooling, pasteurization or sterilization, nutrient analysis, and labeling vary by bank.11 Most DHM banks in North America do not report the nutrient composition of the DHM they sell. Of those that do, only three report nutrients other than protein, energy, and fat. Understanding the nutrient profiles of DHM is essential for creating feeding plans to meet the needs of preterm infants.
Study design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Donor milk samples will be collected from commercially available donor milk banks
Key inclusion criteria (1 listed)
- Donor human milk from commercially available milk banks
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| No interventionThis is an observational collection of data from purchased donor milk samples | Other | – |
Primary outcome
Nutrient composition of donor human milk samples
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2023.
- Derived from this study: PubMed 40836482Gates A, Maria SD, Meredith NA, Houslay T, Stansfield BK. Vitamin A in donor human milk: An experimental study. JPEN J Parenter Enteral Nutr. 2025 Nov;49(8):951-954. doi: 10.1002/jpen.70008. Epub 2025 Aug 20.
- Derived from this study: PubMed 37517552Gates A, Hair AB, Salas AA, Thompson AB, Stansfield BK. Nutrient Composition of Donor Human Milk and Comparisons to Preterm Human Milk. J Nutr. 2023 Sep;153(9):2622-2630. doi: 10.1016/j.tjnut.2023.07.012. Epub 2023 Jul 28.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Milk Collection and Nutrition Disorder, Infant, run by Augusta University at 1 site 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 24 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
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?
Nutrient composition of donor human milk samples (time frame: 6 months). 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 NCT05742815, which also lists 2 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 24 Feb 2023.