Safety and Tolerability of Lactoferrin/FOS in Very Low Birth Weight Infants
NCT ID: NCT03163212
Last Updated: 2017-05-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
EARLY_PHASE1
20 participants
INTERVENTIONAL
2017-06-30
2018-06-30
Brief Summary
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Detailed Description
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1. Lactoferrin/FOS related adverse events and serious adverse events
2. Time reaching full feeds while receiving lactoferrin/FOS (120 ml/kg/day)
3. Episodes of not receiving enteral feedings for \> 24 hours once feeding is initiated
Aim 2: To evaluate lactoferrin/FOS absorption and excretion
1. Examine lactoferrin/FOS levels in saliva, urine, plasma, and stool
2. Examine lactoferrin levels in materal and human donor milk
Aim 3: To evaluate the effect of lactoferrin/FOS on the intestinal microbiome structure
Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Lactoferrin/FOS 100mg/kg
100 mg/kg enteral administration daily for 30 days
Lactoferrin/FOS
Bovine Lactoferrin/FOS 100mg/ml dissolved in sterile water
Lactoferrin/FOS 200mg/kg
200 mg/kg enteral administration daily for 30 days
Lactoferrin/FOS
Bovine Lactoferrin/FOS 100mg/ml dissolved in sterile water
Lactoferrin/FOS 300mg/kg
300 mg/kg enteral administration daily for 30 days
Lactoferrin/FOS
Bovine Lactoferrin/FOS 100mg/ml dissolved in sterile water
Interventions
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Lactoferrin/FOS
Bovine Lactoferrin/FOS 100mg/ml dissolved in sterile water
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* \< 1500 grams birth weight
* \< 37 weeks gestation
Exclusion Criteria
* Known necrotizing enterocolitis or bowel perforation
14 Days
ALL
No
Sponsors
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The Gerber Foundation
OTHER
University of Virginia
OTHER
Responsible Party
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David A Kaufman
Neonatologist
Central Contacts
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Other Identifiers
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19804
Identifier Type: -
Identifier Source: org_study_id
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