Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| The Gerber Foundation | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
To evaluate the safety and tolerability of three different lactoferrin doses in preterm infants
Aim1: To evaluate the safety and tolerability of three different lactoferrin doses in preterm infants
Aim 2: To evaluate lactoferrin absorption and excretion.
Aim 3: To evaluate the effect of lactoferrin on the intestinal microbiome structure.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lactoferrin 100 mg/kg | Experimental | 100 mg/kg enteral administration daily for 30 days |
|
| Lactoferrin 200 mg/kg | Experimental | 200 mg/kg enteral administration daily for 30 days |
|
| Lactoferrin 300 mg/kg | Experimental | 300 mg/kg enteral administration daily for 30 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lactoferrin | Dietary Supplement | Bovine Lactoferrin 100 mg/ml dissolved in sterile water |
|
| Measure | Description | Time Frame |
|---|---|---|
| Definitely related study solution serious adverse event | 30 days while receiving study solution |
| Measure | Description | Time Frame |
|---|---|---|
| Number of infants reaching 120 ml/kg of enteral feeds | Number of infants reaching 120 ml/kg of enteral feeds while receiving study solution | 30 days while receiving study solution |
| Number of days not receiving any feedings after lactoferrin administration |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| David A Kaufman, MD | Contact | 4349245428 | dak4r@virginia.edu |
| Name | Affiliation | Role |
|---|---|---|
| David A Kaufman, MD | University of Virginia School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Virginia Neonatal Intensive Care Unit | Recruiting | Charlottesville | Virginia | 22908 | United States |
At UVA and MTA with outside institutions
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D007781 | Lactoferrin |
| ID | Term |
|---|---|
| D012697 | Serine Endopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
| D006867 | Hydrolases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
Number of days not receiving any feedings after lactoferrin administration begun |
| 30 days while receiving study solution |
| University of Virginia HealthSystem | Recruiting | Charlottesville | Virginia | 22932 | United States |
|
| D004798 |
| Enzymes |
| D045762 | Enzymes and Coenzymes |
| D057057 | Serine Proteases |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D061250 | Transferrins |
| D033862 | Iron-Binding Proteins |
| D002352 | Carrier Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D007782 | Lactoglobulins |
| D000067816 | Whey Proteins |
| D008894 | Milk Proteins |
| D000080224 | Animal Proteins, Dietary |
| D004044 | Dietary Proteins |
| D005916 | Globulins |
| D008667 | Metalloproteins |