Ignite Creation Date:
2025-12-24 @ 12:37 PM
Ignite Modification Date:
2026-01-02 @ 8:00 AM
Study NCT ID:
NCT06243861
Status:
RECRUITING
Last Update Posted:
2024-05-17
First Post:
2024-01-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Attachment Bonding and Neonatal Hospitalization: the Impact of Hospitalization in a Kangaroo Unit
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 96}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-04-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2025-04-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-05-16', 'studyFirstSubmitDate': '2024-01-29', 'studyFirstSubmitQcDate': '2024-01-29', 'lastUpdatePostDateStruct': {'date': '2024-05-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mother-infant bonding', 'timeFrame': 'Up to 3 days after delivery', 'description': "Mother-infant bonding score from Taylor's Mother to Infant Bonding Scale (MIBS)"}], 'secondaryOutcomes': [{'measure': "Assessment of mothers' state and trait anxiety levels", 'timeFrame': 'Up to 3 days after delivery', 'description': "using Spielberger's STAY form Y1 and Y2: a self-reported questionnaire with 20 items assessed on a 4 points scale"}, {'measure': 'Assessment of perceived parenting competence', 'timeFrame': 'Up to 3 days after delivery', 'description': 'using Gibaud-Wallston\'s Parenting Sense of Competence Scale (PSOC). The PSOC is a 17 item scale, with 2 subscales. Each item is rated on a 6 point Likert scale anchored by 1 = "Strongly Disagree" and 6 = "Strongly Agree".'}, {'measure': "Assessment of patients' quality of life", 'timeFrame': 'Up to 3 days after delivery', 'description': 'using the McGill Quality of Life Questionnaire (MQOL). consists of 14 items divided into four domains: The Single-Item Scale (SIS), physical symptoms (three items), feelings and thoughts (seven items), and social (three items).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Postnatal Care']}, 'descriptionModule': {'briefSummary': 'The Kangaroo Unit (UK) takes care of newborns requiring special care or monitoring for a pathology whose clinical situation is stable and whose prognosis is favorable. In order to avoid separating mother and child, these units were created with a care pathway somewhere between that requiring hospitalization in a neonatal unit and that of pathology-free newborns in post-natal care. Theoretically, the mother-child bond created in the UK is as good as that created in conventional post-natal care. However, studies show that there are limits to the quality of the bond in the UK. This study aims to assess whether the mother-child bond is degraded in the UK, in comparison with that of mothers in post-natal care.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patient hospitalized in a Kangaroo Unit or in a post-natal unit', 'genderDescription': 'study conducted in mothers', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient over 18 years of age, hospitalized in a Kangaroo Unit or in a post-natal unit,\n* Affiliated to a social security scheme,\n* fluent in French\n* no objection of participation\n\nExclusion Criteria:\n\n* Patient who :\n\n * given birth to a child who was stillborn or died at birth\n * difficulty understanding written French\n * psychological incapacity (psychiatric disorder, too great a vulnerability) or physical incapacity (physical/motor disability) to answer questionnaires,\n* Patient under court protection, guardianship or curatorship.'}, 'identificationModule': {'nctId': 'NCT06243861', 'acronym': 'UKLA', 'briefTitle': 'Attachment Bonding and Neonatal Hospitalization: the Impact of Hospitalization in a Kangaroo Unit', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Régional Metz-Thionville'}, 'officialTitle': 'Attachment Bonding and Neonatal Hospitalization: the Impact of Hospitalization in a Kangaroo Unit', 'orgStudyIdInfo': {'id': '2023-08Obs-CHRMT'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'kangaroo unit', 'interventionNames': ['Behavioral: Mother-child bond']}, {'label': 'postnatal care', 'interventionNames': ['Behavioral: Mother-child bond']}], 'interventions': [{'name': 'Mother-child bond', 'type': 'BEHAVIORAL', 'description': 'assessing whether the mother-child bond is degraded in the UK, in comparison with that of mothers in post-natal care', 'armGroupLabels': ['kangaroo unit', 'postnatal care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '57085', 'city': 'Metz', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Arpiné EL NAR', 'role': 'CONTACT', 'email': 'arpine.el-nar@chr-metz-thionville.fr', 'phone': '0033387557766'}, {'name': 'Marie-Laure BOYE', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHR Metz-Thionville/Hopital Mercy', 'geoPoint': {'lat': 49.11911, 'lon': 6.17269}}], 'centralContacts': [{'name': 'Arpiné EL NAR, PhD', 'role': 'CONTACT', 'email': 'arpine.el-nar@chr-metz-thionville.fr', 'phone': '0033387557766'}], 'overallOfficials': [{'name': 'Marie-Laure BOYE', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHR Metz Thionville'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Régional Metz-Thionville', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}