Ignite Creation Date:
2025-12-24 @ 7:10 PM
Ignite Modification Date:
2025-12-27 @ 3:16 PM
Study NCT ID:
NCT04395703
Status:
COMPLETED
Last Update Posted:
2022-04-08
First Post:
2020-05-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Baby Friendly Initiative Implementation: Maternity Staff Experiences
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D007407', 'term': 'Interviews as Topic'}, {'id': 'D017144', 'term': 'Focus Groups'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 21}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-10-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2021-10-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-04-07', 'studyFirstSubmitDate': '2020-05-12', 'studyFirstSubmitQcDate': '2020-05-19', 'lastUpdatePostDateStruct': {'date': '2022-04-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-10-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To identify barriers to the successful implementation of Unicef Baby Friendly Initiative within a maternity organisation.', 'timeFrame': '2 years', 'description': 'The aim is to identify themes regarding barriers that are in place when implementing policies into maternity organisations. These will be developed into recommendations which managers and policy makers can utilise to enable change management.'}, {'measure': 'To identify challenges to the successful implementation of Unicef Baby Friendly Initiative within a maternity organisation.', 'timeFrame': '2 years', 'description': 'The aim is to identify themes regarding the challenges that are in place when implementing policies into maternity organisations. These will be developed into recommendations which managers and policy makers can utilise to enable change management.'}, {'measure': 'To identify what facilitates the successful implementation of Unicef Baby Friendly Initiative within a maternity organisation.', 'timeFrame': '2 years', 'description': 'The aim is to identify themes regarding the facilitators when implementing the Unicef Baby Friendly Initiative into maternity organisations. These will be developed into recommendations which managers and policy makers can utilise to enable change management.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Staff experience,barriers,challenges,facilitators'], 'conditions': ['Experience, Life']}, 'descriptionModule': {'briefSummary': 'This qualitative, case study will explore the experiences of maternity staff in England when implementing the World Health Organisation and Unicef Baby Friendly Initiative (BFI) standards within a maternity organisation.', 'detailedDescription': 'A range of maternity staff over 4 UK NHS hospitals will be recruited and interviewed by one chief investigator regarding their experiences of working with the BFI standards in their daily professional practice.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Maternity and neonatal staff who meet the inclusion criteria.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion criteria\n\n* Maternity staff who have had training in and with experience of working with the BFI.\n* Senior neonatal staff working in the maternity unit.\n* Maternity unit management.\n* Staff in specialised infant feeding roles at local hospitals.\n* Student midwives on placement at main study hospital site.\n* English speaking.\n\nExclusion criteria\n\n* Maternity staff with no BFI experience.\n* Medical staff.\n* Community maternity staff.\n* Community nurses and health visitors.\n* Student nurses.'}, 'identificationModule': {'nctId': 'NCT04395703', 'briefTitle': 'Baby Friendly Initiative Implementation: Maternity Staff Experiences', 'organization': {'class': 'OTHER', 'fullName': 'Bournemouth University'}, 'officialTitle': 'Barriers, Challenges and Facilitators for the Unicef Baby Friendly Initiative (BFI): A Qualitative Study of Maternity Staff Experiences', 'orgStudyIdInfo': {'id': '274438'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Maternity staff', 'description': 'Interviews with maternity staff working within a maternity unit including midwifery managers and infant feeding lead staff members.', 'interventionNames': ['Other: Interviews and focus groups']}, {'label': 'Neonatal unit staff', 'description': 'Staff working within a local maternity unit.', 'interventionNames': ['Other: Interviews and focus groups']}], 'interventions': [{'name': 'Interviews and focus groups', 'type': 'OTHER', 'description': 'Unstructured and semi-structured interviews with open ended questions.', 'armGroupLabels': ['Maternity staff', 'Neonatal unit staff']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'DT1 2JY', 'city': 'Dorchester', 'state': 'Dorset', 'country': 'United Kingdom', 'facility': 'Dorset County Hospital NHS Foundation Trust', 'geoPoint': {'lat': 50.71667, 'lon': -2.43333}}], 'overallOfficials': [{'name': 'Hazel Tennant', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Postgraduate Researcher and Midwife'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bournemouth University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Dorset County Hospital NHS Foundation Trust', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}