Ignite Creation Date:
2025-12-25 @ 12:54 AM
Ignite Modification Date:
2026-02-17 @ 7:08 PM
Study NCT ID:
NCT01330667
Status:
WITHDRAWN
Last Update Posted:
2018-11-15
First Post:
2011-02-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Early Limited Formula on Total Serum Bilirubin Among Newborns With Hyperbilirubinemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051556', 'term': 'Hyperbilirubinemia, Neonatal'}, {'id': 'D006932', 'term': 'Hyperbilirubinemia'}, {'id': 'D001942', 'term': 'Breast Feeding'}], 'ancestors': [{'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D005247', 'term': 'Feeding Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C097269', 'term': 'pregestimil'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'funding not available', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2015-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'completionDateStruct': {'date': '2016-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-11-13', 'studyFirstSubmitDate': '2011-02-23', 'studyFirstSubmitQcDate': '2011-04-06', 'lastUpdatePostDateStruct': {'date': '2018-11-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-04-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'TSB meeting or exceeding AAP-recommended phototherapy treatment threshold.', 'timeFrame': 'Up to two weeks after birth', 'description': 'The investigators will compare measured TSB to AAP guideline recommendations for phototherapy treatment and confirming with Bili Tool, an automated program designed for this purpose.'}], 'secondaryOutcomes': [{'measure': 'Receipt of phototherapy and hospital readmission, exclusive and partial breastfeeding at 1 week, 1 month, 2 months, and 3 months; breastfeeding self-efficacy', 'timeFrame': 'Up to three months after birth', 'description': 'The investigators will ask mothers whether the infant received any breast milk in the last 24 hours. For infants whose mothers state they have received breast milk in the last 24 hours, the investigators will ask mothers whether the infant received anything other than breast milk in the last 24 hours. The investigators will ask mothers whether the infant received anything other than breast milk since the prior assessment. The investigators will query subjects using the Breastfeeding Self Efficacy Scale, short form, at enrollment, 1week and at 1 month.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Hyperbilirubinemia', 'Breastfeeding', 'Limited Formula'], 'conditions': ['Hyperbilirubinemia, Neonatal']}, 'descriptionModule': {'briefSummary': 'The investigators propose to conduct an exploratory pilot study, enrolling 30 exclusively breastfeeding newborns 36-96 hours of age, whose Total Serum Bilirubin (TSB) is within 0.1-3 mg/dl of the American Academy of Pediatrics (AAP)-recommended treatment thresholds for Phototherapy (PT). These newborns will be randomly assigned to receive either 10 cc extensively hydrolyzed formula following each breastfeeding using cup, spoon or syringe, or to continue exclusive breastfeeding. Infants will be followed at 1, 2, 3 and 6 months to assess breastfeeding duration and use of formula and complementary foods. Our hypothesis is that limited, small amounts of formula administered without a bottle immediately following breastfeeding might reduce the incidence of severe hyperbilirubinemia among newborns at increased risk of TSB exceeding AAP-recommended thresholds for beginning phototherapy.', 'detailedDescription': 'Inclusion criteria\n\n* Healthy infants ≥ 35 weeks\n* Neonates 36-96 hours old\n* Exclusively breastfeeding\n* TSB 0.1-3 mg/dl below AAP-recommended PT threshold\n* TSB \\< 6 hours ago\n* Mothers English-speaking or Spanish-speaking\n\nOutcome Measures\n\n* Primary outcome: Total Serum Bilirubin\n* Secondary clinical outcomes: Phototherapy, hospital readmission, exclusive and partial breastfeeding at 1 week, 1 month, 2 months, and 3 months; breastfeeding self-efficacy'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '96 Hours', 'minimumAge': '36 Hours', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy infants ≥ 35 weeks\n* Neonates 36-96 hours old\n* Exclusively breastfeeding\n* TSB 0.1-3 mg/dl below AAP-recommended PT threshold\n* TSB \\< 6 hours ago\n* Mothers English-speaking or Spanish-speaking\n\nExclusion Criteria:\n\n* Infants who have already received formula\n* Infants who have received or are receiving Level II or Level III\n* Infants who have already lost ≥ 10% birth weight\n* Infants with Glucose-6-phosphate dehydrogenase deficiency, positive direct antigen testing, cephalohematoma or other extensive bruising'}, 'identificationModule': {'nctId': 'NCT01330667', 'briefTitle': 'Effect of Early Limited Formula on Total Serum Bilirubin Among Newborns With Hyperbilirubinemia', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Francisco'}, 'officialTitle': 'Effect of Early Limited Formula on Total Serum Bilirubin Among Newborns With Hyperbilirubinemia', 'orgStudyIdInfo': {'id': 'ELF for Hyperbilirubinemia'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Formula Supplementation', 'description': 'Participants will supplement feedings with early limited formula following nursing.', 'interventionNames': ['Dietary Supplement: Nutramigen Infant Formula']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Participants will be instructed to continue exclusively breastfeeding with no formula supplementation.'}], 'interventions': [{'name': 'Nutramigen Infant Formula', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Nutramigen'], 'description': "Investigators will advise to supplement with 10cc's of extensively hydrolyzed formula immediately following each breastfeeding until TSB declines.", 'armGroupLabels': ['Formula Supplementation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94122', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'University of California, San Francisco Medical Center', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}], 'overallOfficials': [{'name': 'Valerie Flaherman, MD,MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Francisco'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Francisco', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}