Ignite Creation Date:
2025-12-24 @ 3:37 PM
Ignite Modification Date:
2026-02-26 @ 5:47 AM
Study NCT ID:
NCT01050192
Status:
WITHDRAWN
Last Update Posted:
2017-03-23
First Post:
2010-01-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Nutritional Content of Breast Milk From Mothers of Premies
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D047928', 'term': 'Premature Birth'}, {'id': 'D001942', 'term': 'Breast Feeding'}], 'ancestors': [{'id': 'D007752', 'term': 'Obstetric Labor, Premature'}, {'id': 'D007744', 'term': 'Obstetric Labor Complications'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D005247', 'term': 'Feeding Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Lack of enrollment', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2009-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2010-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-21', 'studyFirstSubmitDate': '2010-01-13', 'studyFirstSubmitQcDate': '2010-01-14', 'lastUpdatePostDateStruct': {'date': '2017-03-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-01-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To determine the correlation, if any, between the nutritional content of breast milk pumped by the mothers of VLBW infants in the NICU and the nutritional value they are actually receiving in a 24 hour period.', 'timeFrame': '28 days of life'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Prematurity', 'Nutrition', 'Breast Feeding'], 'conditions': ['Prematurity', 'Nutrition']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the correlation, if any, between the nutritional content of breast milk pumped by the mothers of very low birth weight (VLBW) infants in the neonatal intensive care unit (NICU) and the nutritional value they are actually receiving in a 24 hour period, since as a practical matter, these may not be the same.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '30 Weeks', 'minimumAge': '23 Weeks', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Neonatal Intensive Care Unit', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Mothers of infants with a gestational age \\<=30 weeks in the NICU who are supplying their own breast milk for use by their baby\n* Reasonable likelihood of survival of infant to 28 days\n* Infant on/ready for oral feeding by DOL 7 days\n* Willing to provide breast milk for their baby\n* Able to produce at least 7mL breast milk per feeding\n* Willing to abide by requirements of the study protocol\n* Documentation of informed consent\n\nExclusion Criteria:\n\n* Unable to provide at least 7mL breast milk per feeding\n* Medically unsuitable to provide breast milk to her baby\n* Maternal age \\<18 years of age'}, 'identificationModule': {'nctId': 'NCT01050192', 'briefTitle': 'Nutritional Content of Breast Milk From Mothers of Premies', 'organization': {'class': 'OTHER', 'fullName': 'Pediatrix'}, 'officialTitle': 'The Nutritional Content of Breast Milk From Mothers of Premature Neonates During the First 28 Days of Life', 'orgStudyIdInfo': {'id': 'Pro0001271'}}, 'contactsLocationsModule': {'locations': [{'city': 'Greenville', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Greenville Memorial Hospital', 'geoPoint': {'lat': 34.85262, 'lon': -82.39401}}], 'overallOfficials': [{'name': 'Reese Clark, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Greenville Memorial Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pediatrix', 'class': 'OTHER'}, 'collaborators': [{'name': 'Prolacta Bioscience', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director Clinical Trial Operations', 'investigatorFullName': 'Amy Kelleher', 'investigatorAffiliation': 'Pediatrix'}}}}