Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
20 participants
OBSERVATIONAL
2022-08-01
2023-12-31
Brief Summary
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Detailed Description
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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
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Study Design
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OTHER
OTHER
Interventions
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No intervention
This is an observational collection of data from purchased donor milk samples
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
ALL
No
Sponsors
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Augusta University
OTHER
Responsible Party
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Amy Gates
Adjunct Intructor
Locations
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Augusta University
Augusta, Georgia, United States
Countries
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References
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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 Aug 20. doi: 10.1002/jpen.70008. Online ahead of print.
Gates 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.
Other Identifiers
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1823198-1
Identifier Type: -
Identifier Source: org_study_id
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