Safety and Tolerability of Lactoferrin in Very Low Birth Weight Infants
NCT ID: NCT02731092
Last Updated: 2016-04-19
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
PHASE1
30 participants
INTERVENTIONAL
2016-04-30
2017-03-31
Brief Summary
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Detailed Description
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1. Lactoferrin related adverse events and serious adverse events
2. Number of infants reaching full feeds while receiving lactoferrin (120 ml/kg/day)
3. Episodes of not receiving enteral feedings for \> 24 hours once feeding is initiated
Aim 2: To evaluate lactoferrin absorption and excretion.
1. Examine lactoferrin levels in saliva, urine, plasma and stool
2. Examine lactoferrin levels in maternal and human donor milk.
Aim 3: To evaluate the effect of lactoferrin on the intestinal microbiome structure.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Lactoferrin 100 mg/kg
100 mg/kg enteral administration daily for 30 days
Lactoferrin
Bovine Lactoferrin 100 mg/ml dissolved in sterile water
Lactoferrin 200 mg/kg
200 mg/kg enteral administration daily for 30 days
Lactoferrin
Bovine Lactoferrin 100 mg/ml dissolved in sterile water
Lactoferrin 300 mg/kg
300 mg/kg enteral administration daily for 30 days
Lactoferrin
Bovine Lactoferrin 100 mg/ml dissolved in sterile water
Interventions
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Lactoferrin
Bovine Lactoferrin 100 mg/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
MD
Principal Investigators
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David A Kaufman, MD
Role: PRINCIPAL_INVESTIGATOR
University of Virginia School of Medicine
Locations
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University of Virginia Neonatal Intensive Care Unit
Charlottesville, Virginia, United States
University of Virginia HealthSystem
Charlottesville, Virginia, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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IRB-HSR 18130
Identifier Type: -
Identifier Source: org_study_id
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