Ignite Creation Date:
2025-12-26 @ 10:32 AM
Ignite Modification Date:
2025-12-26 @ 10:32 AM
Study NCT ID:
NCT00952328
Status:
COMPLETED
Last Update Posted:
2014-04-10
First Post:
2009-07-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Early Limited Formula Use on Breastfeeding Outcomes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001942', 'term': 'Breast Feeding'}], 'ancestors': [{'id': 'D005247', 'term': 'Feeding Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-04', 'completionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-04-09', 'studyFirstSubmitDate': '2009-07-29', 'studyFirstSubmitQcDate': '2009-08-03', 'lastUpdatePostDateStruct': {'date': '2014-04-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-08-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Is infant receiving exclusively breast milk at 8 days of life?', 'timeFrame': '8 days following baseline'}], 'secondaryOutcomes': [{'measure': 'Is infant receiving exclusive or partial breastfeeding at 1 month, 2 months, and 3 months?', 'timeFrame': '1-3 months following baseline'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['breastfeeding outcomes', 'breastfeeding self-efficacy', 'infant weight loss'], 'conditions': ['Breastfeeding']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to conduct a pilot randomized controlled trial of the effect of early limited formula supplementation on breastfeeding-related outcomes for infants with high early weight loss. The investigators will enroll 40 exclusively breastfeeding infants at 24-48 hours of age and will randomly assign them to early limited formula supplementation following nursing (intervention group) or to no formula feeding (control group). Both groups will receive intensive lactation support. Outcome variables will include breastfeeding status on day-of-life 8, weight nadir, breastfeeding self-efficacy, maternal satisfaction, and exclusive and partial breastfeeding at 1-3 months. The hypothesis for this study is that early limited formula supplementation might help infants with early weight loss avoid eventual weight loss ≥ 10% and associated breastfeeding problems.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '48 Hours', 'minimumAge': '24 Hours', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy term infants (37 to 42 weeks gestation)\n* Infants who have lost 5% of their birth weight at \\<36 hours of age\n\nExclusion Criteria:\n\n* Infants who have received formula or water\n* Mothers who are producing mature milk supply\n* Infants receiving Level II or Level III care other than healthy term infants with routine complete blood count and blood tests pending'}, 'identificationModule': {'nctId': 'NCT00952328', 'acronym': 'ELF', 'briefTitle': 'Effect of Early Limited Formula Use on Breastfeeding Outcomes', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Francisco'}, 'officialTitle': 'Effect of Early Limited Formula Use on Breastfeeding Outcomes', 'orgStudyIdInfo': {'id': 'H49316-34032-01'}, 'secondaryIdInfos': [{'id': '5 K12 HD052 163 Development'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Limited Formula', 'description': 'Participants will supplement feedings with early limited formula following nursing', 'interventionNames': ['Dietary Supplement: Nutramigen infant formula']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Participants are instructed to continue exclusively breastfeeding; no use of formula'}], 'interventions': [{'name': 'Nutramigen infant formula', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Investigators will advise mothers to supplement with 10 cc of elemental formula immediately following each breastfeeding and to discontinue formula once mature milk production begins.', 'armGroupLabels': ['Limited Formula']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94143', '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'}, 'collaborators': [{'name': 'Stanford University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}