Ignite Creation Date:
2025-12-24 @ 11:19 PM
Ignite Modification Date:
2026-02-24 @ 8:27 AM
Study NCT ID:
NCT00527956
Status:
COMPLETED
Last Update Posted:
2008-06-09
First Post:
2007-09-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Facilitation and Barriers to Breastfeeding in the NICU
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001942', 'term': 'Breast Feeding'}, {'id': 'D047928', 'term': 'Premature Birth'}], 'ancestors': [{'id': 'D005247', 'term': 'Feeding Behavior'}, {'id': 'D001519', 'term': 'Behavior'}, {'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'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 8}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-06', 'completionDateStruct': {'date': '2008-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-06-06', 'studyFirstSubmitDate': '2007-09-10', 'studyFirstSubmitQcDate': '2007-09-10', 'lastUpdatePostDateStruct': {'date': '2008-06-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-09-11', 'type': 'ESTIMATED'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Breastfeeding premature infants'], 'conditions': ['Breastfeeding', 'Prematurity']}, 'descriptionModule': {'briefSummary': "To date, there is a paucity of research focusing on maternal breastfeeding goals, how these goals may change after an unexpected event such as a preterm birth, and how mothers of ill and preterm infants define breastfeeding success. No studies were identified that focused exclusively on the breastfeeding goals of mothers of hospitalized preterm infants\n\nThe purpose of this study is to answer the following research questions: 1) What are the breastfeeding goals of mothers with preterm infants in the NICU? and 2) What are mothers' perceptions of facilitators and barriers to meeting their breastfeeding goals in the NICU?", 'detailedDescription': 'As the objective of this study is to describe the breastfeeding goals of mothers and their perceptions of breastfeeding support in the NICU, this study will follow a descriptive, qualitative design. Mothers of preterm newborns in the Royal Victoria Hospital will participate in a semi-structured interview about their breastfeeding goals and what they perceived to be facilitators and barriers to achieving their intended goals. During the interviews, the mothers will be asked a set of socio-demographic questions, open-ended questions about their breastfeeding goals, and open-ended questions about their perceptions of barriers and facilitators to meeting these goals in the NICU Participants may also receive one follow-up phone call to clarify their responses to the questions or to validate the information obtained from the interview.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. have one (or more) infant(s) currently admitted in the NICU at the RVH;\n2. intended to provide breast milk to their infant(s);\n3. are able to speak English; and\n4. are willing to be audiotaped during the interview.\n\nExclusion Criteria:\n\nInclude mothers who:\n\n1. never intended to breastfeed;\n2. have high risk social situations (for example, known maternal mental illness; involvement of youth protection; known alcohol and drug abuse; adoption; identified congenital anomalies);\n3. gave birth at term; and\n4. have infants with significant birth defects or serious medical conditions in addition to prematurity.'}, 'identificationModule': {'nctId': 'NCT00527956', 'briefTitle': 'Facilitation and Barriers to Breastfeeding in the NICU', 'organization': {'class': 'OTHER', 'fullName': 'McGill University Health Centre/Research Institute of the McGill University Health Centre'}, 'orgStudyIdInfo': {'id': 'PSY 07-009'}}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Luisa Ciofani, RN, M.Sc.(A)', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'McGill Univsersity Health Centre'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'McGill University Health Centre/Research Institute of the McGill University Health Centre', 'class': 'OTHER'}}}}