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Slow accrual.
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| Name | Class |
|---|---|
| Mothers' Milk Bank Northeast | OTHER |
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Human Breast milk in young children with Norovirus Infection
The investigators hypothesize that children with clinically significant norovirus infection of the gut who receive enteral human milk will more successfully clear the virus or experience improved symptoms compared to children not receiving human milk.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Donor Breastmilk | Experimental | Donated human milk is subjected to pasteurization prior to use. Milk consumption is to be overseen by a Registered Dietician. Oral or enteral milk feeding will begin at 180 ml/day and will be advanced as quickly as tolerated to a goal of 360 ml/day for 6 weeks. If symptoms and stool tests for norovirus do not improve after 6 weeks, milk administration may continue for an additional 6 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Donor Breastmilk | Dietary Supplement | Donor breastmilk will be obtained from the Mother's Milk Bank of New England. |
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| Measure | Description | Time Frame |
|---|---|---|
| Loose/Unformed/Liquid Stools or Abdominal Cramping | Episodes or number of days of loose/unformed/liquid stools or abdominal cramping will be reported. | Up to 12 weeks |
| Norovirus | Stool samples will be tested for the presence of norovirus. | Up to 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Javier El-Bietar, MD | Children's Hospital Medical Center, Cincinnati | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229 | United States |
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| ID | Term |
|---|---|
| D017250 | Caliciviridae Infections |
| ID | Term |
|---|---|
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
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