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| Name | Class |
|---|---|
| The Gerber Foundation | OTHER |
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This study will examine the safety and tolerability of supplementation with bovine lactoferrin with fructo-oligosaccharide a simple sugar in very low birth weight infants. Lactoferrin is a major whey protein in mother's milk and plays a role in promoting a mature and healthy gut. It also has antimicrobial and immunomodulation activities.
Aim 1: To evaluate the safety and tolerability of three different lactoferrin/FOS doses in preterm infants
Aim 2: To evaluate lactoferrin/FOS absorption and excretion
Aim 3: To evaluate the effect of lactoferrin/FOS on the intestinal microbiome structure
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lactoferrin/FOS 100mg/kg | Experimental | 100 mg/kg enteral administration daily for 30 days |
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| Lactoferrin/FOS 200mg/kg | Experimental | 200 mg/kg enteral administration daily for 30 days |
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| Lactoferrin/FOS 300mg/kg | Experimental | 300 mg/kg enteral administration daily for 30 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lactoferrin/FOS | Dietary Supplement | Bovine Lactoferrin/FOS 100mg/ml dissolved in sterile water |
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| Measure | Description | Time Frame |
|---|---|---|
| Definitely related study solution serious adverse event | 30 days while receiving study solution |
| Measure | Description | Time Frame |
|---|---|---|
| Day after birth to reach 120ml/kg of enteral feeds | 30 days while receiving study solution | |
| Number of days not receiving any feedings after lactoferrin/FOS administration | 30 days while receiving study solution |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| David A Kaufman, MD | Contact | 434-924-5428 | dak4r@virginia.edu |
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Specimens which have been unidentified may be shared with outside labs for analysis
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Dose escalation design
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