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| ID | Type | Description | Link |
|---|---|---|---|
| K23HD057232 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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Breastfeeding is an important health-promoting behavior. Human milk is the ideal diet for all infants, optimizes intellect, and provides protection against infectious and atopic diseases in childhood as well as decreasing risks for obesity, hypertension and other chronic diseases. Infants with the highest risk of life-long disability, very low birthweight (VLBW) preterm infants, are breastfed at some of the lowest rates in the US. Maternal milk is not always available, and pasteurized donor human milk is an alternative that requires investigation. Whether donor milk conveys health and developmental advantages similar to those bestowed by maternal milk is unknown. By determining the effects of donor milk on health and developmental outcomes when compared to preterm infant formula, the investigators seek to optimize outcomes in this fragile population. The hypothesis of our donor milk research is that a donor human milk diet in non-maternal milk fed VLBW infants is associated with better neurodevelopmental outcome scores at 18-22 months adjusted age than a preterm infant formula diet.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Donor Human Milk | Experimental | VLBW infants randomized to be fed donor human milk, fortified as appropriate, for all feedings for which maternal milk is not available, including infants who receive no maternal milk |
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| Preterm Formula | Experimental | VLBW infants randomized to receive preterm infant formula for any feedings for which maternal milk is unavailable, including infants receiving no maternal milk |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Donor Human Milk | Dietary Supplement | Donor Human Milk, obtained from the Mother's Milk of Iowa, a HMBANA milk bank |
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| Measure | Description | Time Frame |
|---|---|---|
| Cognitive scale score of the Bayley Scales of Infant Development, III | We will administer the BSID III to all subjects at 18-22 mo of age, adjusted for prematurity. We will compare the scores between subjects who received donor human milk to those who received preterm infant formula | 18 - 22 months' adjusted age |
| Measure | Description | Time Frame |
|---|---|---|
| Late Onset sepsis | We will compare rates of in-hospital confirmed late onset sepsis in VLBW infants receiving donor human milk and preterm formula | 4 months |
| length of hospital stay | We will compare the length of initial hospital stay between infants who receive donor human milk and those who receive preterm infant formula |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tarah T Colaizy, MD, MPH | University of Iowa | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Iowa | Iowa City | Iowa | 52242 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39239939 | Derived | Quigley 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. |
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Contact PI to discuss data sharing
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| ID | Term |
|---|---|
| D047928 | Premature Birth |
| D001942 | Breast Feeding |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| 4 months |
| D000091642 | Urogenital Diseases |
| D005247 | Feeding Behavior |
| D001519 | Behavior |