Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT05742815 |
| Other study ID # |
1823198-1 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
August 1, 2022 |
| Est. completion date |
December 31, 2023 |
Study information
| Verified date |
February 2023 |
| Source |
Augusta University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical 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
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.
