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The purpose of this study is to compare if newborn infant hypoglycemia can be improved with bottle supplementation of commercially-sterilized donor human milk compared to standard infant formula. Hypothesis is that supplementation with commercially-sterilized donor human milk will improve hypoglycemia and limit formula use in exclusively breastfed infants.
Enrolled infant participants will receive a maximum of two bottle feeding supplementations (of their designated treatment arm for either 20 calorie-per-ounce commercially-sterilized donor human milk OR 20-calorie-per-ounce standard infant formula) as treatment if they meet hypoglycemia criteria. Infant participants will complete the study if 1) they have received two bottle feeding supplementations for treatment of hypoglycemia, 2) they only received one bottle supplementation and hypoglycemia resolved, 3) if the medical teams deems the infants requires a higher level of care for their hypoglycemia (example: admission to the newborn intensive care unit for intravenous fluids with dextrose).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Infant Formula | Active Comparator | Infants in this randomized treatment arm will receive bottle supplementation of up to 15 milliliters of standard 20 calorie-per-ounce infant formula up to two times during the duration of the study to treat hypoglycemia. |
|
| Commercially-Sterilized Donor Human Milk | Experimental | Infants in this randomized treatment arm will receive bottle supplementation of up to 15 milliliters of 20 calorie-per-ounce commercially-sterilized donor human milk up to two times during the duration of the study to treat hypoglycemia. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bottle Supplementation--Commercially-Sterilized Donor Human Milk | Dietary Supplement | Supplementation by bottle with 20-calorie-per-ounce commercially-sterilized donor human milk (up to 15 ml, up to two times) for infants meeting hypoglycemia criteria and randomized to this treatment arm. |
| Measure | Description | Time Frame |
|---|---|---|
| Effectiveness of Resolving Neonatal Hypoglycemia: Blood glucose levels | To compare the effectiveness of commercially-sterilized donor human milk bottle supplementation for the treatment of hypoglycemia in the breastfed infant in the normal newborn nursery compared to bottle supplementation with standard infant formula. | Blood glucose levels will be monitored within 60 minutes of initiating a feeding. Overall outcomes for each treatment arm will be compared at the completion of the study for all enrolled participants. |
| Measure | Description | Time Frame |
|---|---|---|
| Exclusive Breastfeeding Duration | To assess if donor human milk supplementation (when compared to formula supplementation) impacts rate of exclusive breastfeeding during the first 6 months of life. | Families of consented participants will be contacted when the enrolled infant is 6 months old. |
| Parenteral Satisfaction of Infant Feeding: Parenteral satisfaction surveys |
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Mother-infant pairs will be consented for participation via informed written consent.
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Melissa K Thoene, RD, PhD | Nebraska Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Nebraska Medical Center | Omaha | Nebraska | 68198 | United States |
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| Bottle Supplementation--Standard Infant Formula | Dietary Supplement | Supplementation by bottle with 20-calorie-per-ounce standard infant formula (up to 15 ml, up to two times) for infants meeting hypoglycemia criteria and randomized to this treatment arm. |
|
To compare if donor human milk supplementation (when compared to formula supplementation) improves parental satisfaction related to infant feeding during post-partum hospitalization. |
| Parenteral satisfaction surveys will be completed prior to mother's hospital discharge (within 72 hours following delivery). |
| ID | Term |
|---|---|
| D007003 | Hypoglycemia |
| D001942 | Breast Feeding |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D005247 | Feeding Behavior |
| D001519 | Behavior |
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