Ignite Creation Date:
2025-12-25 @ 1:47 AM
Ignite Modification Date:
2025-12-26 @ 12:28 AM
Study NCT ID:
NCT04852094
Status:
UNKNOWN
Last Update Posted:
2021-04-21
First Post:
2021-04-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Family-centered Round in Neonatology
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': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-09-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-04-15', 'studyFirstSubmitDate': '2021-04-11', 'studyFirstSubmitQcDate': '2021-04-15', 'lastUpdatePostDateStruct': {'date': '2021-04-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Experience of participating to a Family-Centered Care (FCR)', 'timeFrame': "1 day during the last week of their newborn 'hospitalisation", 'description': 'Qualitative focus group interview performed at one occasion where the parent describes the experience of the FCR'}], 'secondaryOutcomes': [{'measure': 'Experience of staff members in participating to a (FCR)', 'timeFrame': '1 day after 3 months of FCR experience', 'description': 'Qualitative focus group interview performed at one occasion where the staff members describes the experience of the FCR'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Newborn', 'Preterm', 'medical round', 'family-centered care', 'NICU'], 'conditions': ['Prematurity']}, 'descriptionModule': {'briefSummary': 'The family-centered care is based on dignity and respect, information sharing, collaboration and participation in care and decision-making. In a neonatal unit, the medical round by the attending physician is an important moment for shairing information with the medical and nursing staff and for the decision making process. In France, parents are rarely actively involved in the medical round. The aim of this study is to plan the implantation of the Family-centered round in a neonatal department using the 6 steps of the "Intervention mapping": 1/needs assessment; 2/ performance and change objectives; 3/ theory-based framework; Curriculum development; 5- adoption and implementation; 6- evaluation and dissemination'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Parents group: age, parity, education and income level Staff group: age, gender, years of experience in the NICU, profession', 'healthyVolunteers': False, 'eligibilityCriteria': 'Parents Group:\n\nInclusion Criteria:\n\n* French speaking\n* voluntary to participate\n* parents of an hospitalized newborn\n\nExclusion Criteria:\n\n* not fluent in French speaking\n* mental health problems\n\nProfessional group:\n\n* any staff member\n* voluntary to participate'}, 'identificationModule': {'nctId': 'NCT04852094', 'acronym': 'VINCI', 'briefTitle': 'Family-centered Round in Neonatology', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Brest'}, 'officialTitle': 'Family-centered Round in Neonatal Units : Process Development and Implementation Using the Intervention Mapping', 'orgStudyIdInfo': {'id': 'VINCI'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Parents', 'description': 'parents of hospitalized children, speaking and understanding enough French, not presenting psychiatric disorders, voluntary to participate in focus groups', 'interventionNames': ['Other: Qualitative focus group']}, {'label': 'Professionals', 'description': 'Nurses, assistant nurses, psychologist, physiotherapist, physicians, residents and fellows', 'interventionNames': ['Other: Qualitative focus group']}], 'interventions': [{'name': 'Qualitative focus group', 'type': 'OTHER', 'description': 'A qualitative focus group is performed with staff members and parents of hospitalised newborns in a NICU during Family-centered rounds management. The transcribed interviews are analyzed with qualitative content analysis in order to illuminate the experience, feelings and thoughts arisen among the staff members and the parents.', 'armGroupLabels': ['Parents', 'Professionals']}]}, 'contactsLocationsModule': {'locations': [{'zip': '29609', 'city': 'Brest', 'country': 'France', 'contacts': [{'name': 'Jean-Michel ROUE', 'role': 'CONTACT', 'email': 'jean-michel.roue@chu-brest.fr'}], 'facility': 'CHRU de Brest', 'geoPoint': {'lat': 48.39029, 'lon': -4.48628}}], 'centralContacts': [{'name': 'Jacques Sizun, MD', 'role': 'CONTACT', 'email': 'sizun.j@chu-toulouse.fr', 'phone': '+33561776280'}, {'name': 'Jean-Michel Roue, MD, Phd', 'role': 'CONTACT', 'email': 'jean-michel.roue@chu-brest.fr'}], 'overallOfficials': [{'name': 'Jacques Sizun', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Brest'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Brest', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}