Ignite Creation Date:
2025-12-26 @ 5:24 PM
Ignite Modification Date:
2025-12-26 @ 5:24 PM
Study NCT ID:
NCT00418106
Status:
COMPLETED
Last Update Posted:
2008-01-18
First Post:
2007-01-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Kangaroo Holding Effects on Breast Milk
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D047928', 'term': 'Premature Birth'}], '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-01', 'completionDateStruct': {'date': '2006-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-01-16', 'studyFirstSubmitDate': '2007-01-02', 'studyFirstSubmitQcDate': '2007-01-02', 'lastUpdatePostDateStruct': {'date': '2008-01-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-01-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Breast milk production and composition', 'timeFrame': '1 week'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Premature birth', 'Pumping breast milk', 'Kangaroo holding'], 'conditions': ['Premature Birth']}, 'descriptionModule': {'briefSummary': 'Kangaroo holding is a skin-to-skin method of holding a baby. Many research studies have investigated the maternal and infant benefits associated with kangaroo holding. The purpose of this study is to determine if kangaroo holding a baby changes the amount and composition of breast milk pumped before and after the kangaroo holding session.\n\nHypotheses:\n\n1. There is a significant difference in volume of maternal breast milk pumped after kangaroo holding premature infants as compared to maternal breast milk pumped after non-holding conditions\n2. There is a significant difference in the composition of maternal breast milk pumped after kangaroo holding premature infants as compared to maternal breast milk pumped after non-holding condition.', 'detailedDescription': "This study will address two of the overwhelming challenges in the physiologic care of premature infants in the neonatal intensive care unit (NICU) environment. The first challenge is promoting neonatal growth through providing a careful balance of nutrition to caloric expenditure for premature infants. The second challenge is supporting parents in the intensive, technology driven environment of the NICU to merge physiologic care with parental-infant interaction through touch, communication, and maternal intervention. The vast majority of mothers with premature infants express breast milk for early feedings, however milk production tends to diminish three to four weeks after delivery. The practice of skin-to-skin holding is thought to promote the mother's ability to produce breast milk, but had not been empirically tested. This study will examine the relationship of kangaroo holding on mother's breast milk production and composition."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '14 Days', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Mothers of preterm infants', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Birth weight \\</= 2000 grams\n* Gestational age 26-34 weeks at birth\n* Medically stable at start of study\n* \\< 14 days old at start of study\n\nExclusion Criteria:\n\n* Infants receiving phototherapy\n* Suspected congenital abnormalities\n* Overwhelming sepsis\n* Cardiac Abnormalities\n* Suspected infections'}, 'identificationModule': {'nctId': 'NCT00418106', 'briefTitle': 'Kangaroo Holding Effects on Breast Milk', 'organization': {'class': 'OTHER', 'fullName': 'Christiana Care Health Services'}, 'officialTitle': 'Early Kangaroo Holding Effects on Breast Milk Composition', 'orgStudyIdInfo': {'id': '24211'}}, 'armsInterventionsModule': {'armGroups': [{'label': '1', 'description': 'Mothers who are pumping breast milk and who are willing to kangaroo hold their infant.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '19718', 'city': 'Newark', 'state': 'Delaware', 'country': 'United States', 'facility': 'Christiana Hospital', 'geoPoint': {'lat': 39.68372, 'lon': -75.74966}}], 'overallOfficials': [{'name': 'Amy N. Johnson, DNSc, RNC', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Christiana Care Health Services'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Christiana Care Health Services', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Delaware', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Amy N. Johnson, DNSc, RN', 'oldOrganization': 'Christiana Hospital'}}}}