Ignite Creation Date:
2025-12-24 @ 3:50 PM
Ignite Modification Date:
2026-01-14 @ 2:55 AM
Study NCT ID:
NCT02731092
Status:
UNKNOWN
Last Update Posted:
2016-04-19
First Post:
2016-03-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Tolerability of Lactoferrin in Very Low Birth Weight Infants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D007781', 'term': 'Lactoferrin'}], 'ancestors': [{'id': 'D012697', 'term': 'Serine Endopeptidases'}, {'id': 'D010450', 'term': 'Endopeptidases'}, {'id': 'D010447', 'term': 'Peptide Hydrolases'}, {'id': 'D006867', 'term': 'Hydrolases'}, {'id': 'D004798', 'term': 'Enzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D057057', 'term': 'Serine Proteases'}, {'id': 'D006023', 'term': 'Glycoproteins'}, {'id': 'D006001', 'term': 'Glycoconjugates'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D061250', 'term': 'Transferrins'}, {'id': 'D033862', 'term': 'Iron-Binding Proteins'}, {'id': 'D002352', 'term': 'Carrier Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D007782', 'term': 'Lactoglobulins'}, {'id': 'D000067816', 'term': 'Whey Proteins'}, {'id': 'D008894', 'term': 'Milk Proteins'}, {'id': 'D000080224', 'term': 'Animal Proteins, Dietary'}, {'id': 'D004044', 'term': 'Dietary Proteins'}, {'id': 'D005916', 'term': 'Globulins'}, {'id': 'D008667', 'term': 'Metalloproteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'completionDateStruct': {'date': '2017-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-04-18', 'studyFirstSubmitDate': '2016-03-18', 'studyFirstSubmitQcDate': '2016-04-06', 'lastUpdatePostDateStruct': {'date': '2016-04-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-04-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Definitely related study solution serious adverse event', 'timeFrame': '30 days while receiving study solution'}], 'secondaryOutcomes': [{'measure': 'Number of infants reaching 120 ml/kg of enteral feeds', 'timeFrame': '30 days while receiving study solution', 'description': 'Number of infants reaching 120 ml/kg of enteral feeds while receiving study solution'}, {'measure': 'Number of days not receiving any feedings after lactoferrin administration', 'timeFrame': '30 days while receiving study solution', 'description': 'Number of days not receiving any feedings after lactoferrin administration begun'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['lactoferrin', 'very low birth weight infants', 'preterm infants'], 'conditions': ['Very Low Birth Weight Infants']}, 'descriptionModule': {'briefSummary': 'To evaluate the safety and tolerability of three different lactoferrin doses in preterm infants', 'detailedDescription': 'Aim1: To evaluate the safety and tolerability of three different lactoferrin doses in preterm infants\n\n1. Lactoferrin related adverse events and serious adverse events\n2. Number of infants reaching full feeds while receiving lactoferrin (120 ml/kg/day)\n3. Episodes of not receiving enteral feedings for \\> 24 hours once feeding is initiated\n\nAim 2: To evaluate lactoferrin absorption and excretion.\n\n1. Examine lactoferrin levels in saliva, urine, plasma and stool\n2. Examine lactoferrin levels in maternal and human donor milk.\n\nAim 3: To evaluate the effect of lactoferrin on the intestinal microbiome structure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '14 Days', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* \\< 15 days of age and receiving enteral feedings\n* \\< 1500 grams birth weight\n* \\<37 weeks gestation\n\nExclusion Criteria:\n\n* Congenital bowel obstruction ( esophageal, duodenal, small bowel or anal atresias, Hirschsprung disease, malrotation)\n* Known necrotizing enterocolitis or bowel perforation'}, 'identificationModule': {'nctId': 'NCT02731092', 'briefTitle': 'Safety and Tolerability of Lactoferrin in Very Low Birth Weight Infants', 'organization': {'class': 'OTHER', 'fullName': 'University of Virginia'}, 'officialTitle': 'Safety and Tolerability of Lactoferrin in Very Low Birth Weight Infants', 'orgStudyIdInfo': {'id': 'IRB-HSR 18130'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lactoferrin 100 mg/kg', 'description': '100 mg/kg enteral administration daily for 30 days', 'interventionNames': ['Dietary Supplement: Lactoferrin']}, {'type': 'EXPERIMENTAL', 'label': 'Lactoferrin 200 mg/kg', 'description': '200 mg/kg enteral administration daily for 30 days', 'interventionNames': ['Dietary Supplement: Lactoferrin']}, {'type': 'EXPERIMENTAL', 'label': 'Lactoferrin 300 mg/kg', 'description': '300 mg/kg enteral administration daily for 30 days', 'interventionNames': ['Dietary Supplement: Lactoferrin']}], 'interventions': [{'name': 'Lactoferrin', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Bioferrin® 2000'], 'description': 'Bovine Lactoferrin 100 mg/ml dissolved in sterile water', 'armGroupLabels': ['Lactoferrin 100 mg/kg', 'Lactoferrin 200 mg/kg', 'Lactoferrin 300 mg/kg']}]}, 'contactsLocationsModule': {'locations': [{'zip': '22908', 'city': 'Charlottesville', 'state': 'Virginia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'David Kaufman, MD', 'role': 'CONTACT', 'email': 'Dak4r@virginia.edu', 'phone': '434-924-9114'}, {'name': 'David Kaufman, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Virginia Neonatal Intensive Care Unit', 'geoPoint': {'lat': 38.02931, 'lon': -78.47668}}, {'zip': '22932', 'city': 'Charlottesville', 'state': 'Virginia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'David A Kaufman, MD', 'role': 'CONTACT', 'email': 'dak4r@virginia.edu', 'phone': '434-924-5428'}], 'facility': 'University of Virginia HealthSystem', 'geoPoint': {'lat': 38.02931, 'lon': -78.47668}}], 'centralContacts': [{'name': 'David A Kaufman, MD', 'role': 'CONTACT', 'email': 'dak4r@virginia.edu', 'phone': '4349245428'}], 'overallOfficials': [{'name': 'David A Kaufman, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Virginia School of Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'At UVA and MTA with outside institutions'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Virginia', 'class': 'OTHER'}, 'collaborators': [{'name': 'The Gerber Foundation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'David A Kaufman', 'investigatorAffiliation': 'University of Virginia'}}}}