Ignite Creation Date:
2025-12-25 @ 2:08 AM
Ignite Modification Date:
2026-02-22 @ 9:05 AM
Study NCT ID:
NCT07237360
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-11-19
First Post:
2025-11-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Prevention of Safe Sleeping and Unexpected Infant Death
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': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-11-30', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-14', 'studyFirstSubmitDate': '2025-11-14', 'studyFirstSubmitQcDate': '2025-11-14', 'lastUpdatePostDateStruct': {'date': '2025-11-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-11-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Increase in the number of babies lying well on their backs after the guided interview VS the number of babies lying well on their backs before the guided interview', 'timeFrame': 'During the interview of the family, about 1 hour'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Unexpected Infant Death', 'Prevention & Control', 'Safe Sleeping']}, 'descriptionModule': {'briefSummary': 'The sudden unexpected infant death (SUID) is defined as "the sudden death of a child aged from 1 month to 1 year who had been healthy until then, whereas nothing in his known history or in the history of events could have allowed him to predict". In France, the French High Autority of Health (Haute Autorité de Santé (HAS)) has set the upper age limit at 2 years.\n\nAccording to french statistics, between 250 and 350 babies die each year of unexpected infant death. It is the leading cause of infant mortality in developed countries, with all the devastating psychological, social and legal consequences for families. The national prevention campaigns for the "back to sleep" SUID carried out in the 1990s allowed a 75% decrease in the number of SUID. Yet, still at the moment, around 150 deaths could be avoided each year in France by respecting strict dorsal sleeping recommendations and a safe environment.\n\nAccording to the SUID register of Nantes (France) of April 2024, 75% of deaths occur before the child\'s six months. The risk factors are mainly prematurity, exposure to tobacco (during and after pregnancy), and a sleeping mode not recommended by HAS. Indeed, on the day of death, 20% of babies were lying on their stomach or side, 30% shared their bed and 59% were lying in bedding at risk of containment or obstruction of the upper airway.\n\nAccording to the database of National Association of Infant Death Unexpected Reference Centers since 2022, there has been a resurgence in the number of these deaths. This proves the urgency of prevention on this public health issue.\n\nIn parallel, we do not know why the number of SUID is not decreasing in correlation with the decrease in the birth rate in France. Moreover, it would be interesting to know the reasons why parents do not follow the recommendations of the HAS for their baby to sleep safely.\n\nThus, I wish to evaluate the impact of systematic prevention by the Advanced Practice Nurse with the parents of infants aged 0 to 6 months presenting to the Pediatric Emergency and know their barriers/levers to change.\n\nMy research question is therefore titled:\n\nWhy and how many infants under 6 months sleep in insecurity compared to lying babies according to the international recommendations ?'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '6 Months', 'minimumAge': '0 Months', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Parents of children from 0 to 6 months consulting at the Pediatric Emergency Department of University Hospital of Angers.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All parents consulting the Pediatric Emergency Department of University Hospital of Angers for their baby aged 0 to 6 months\n\nExclusion Criteria:\n\n* Any other person consulting for a baby aged 0 to 6 months who is not the parent of the baby: a grandparent, an uncle, an aunt, a childminder, the nursery manager, a friend of the parents, etc.\n* Parent refusing the use of their data\n* Parent and/or child under legal protection\n* Parent who does not understand French'}, 'identificationModule': {'nctId': 'NCT07237360', 'acronym': 'MinUTE', 'briefTitle': 'Impact of Prevention of Safe Sleeping and Unexpected Infant Death', 'organization': {'class': 'OTHER_GOV', 'fullName': 'University Hospital, Angers'}, 'officialTitle': 'Impact in Pediatric Emergency Departments of a Systematic Individualized Interview Conducted by an Advanced Practice Nurse, on the Prevention of Safe Sleeping and Unexpected Infant Death, in a Population of Infants From 0 to 6 Months', 'orgStudyIdInfo': {'id': '49RC25_0113'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Emergencies babies', 'interventionNames': ['Other: Sleeping mode']}], 'interventions': [{'name': 'Sleeping mode', 'type': 'OTHER', 'description': 'Smoking habits, socio-professional category', 'armGroupLabels': ['Emergencies babies']}]}, 'contactsLocationsModule': {'locations': [{'zip': '49933', 'city': 'Angers', 'country': 'France', 'facility': 'CHU Angers', 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}], 'centralContacts': [{'name': 'Gaëlle SORIN', 'role': 'CONTACT', 'email': 'gaelle.sorin@chu-angers.fr', 'phone': '+33241354427'}, {'name': 'Elise HOUSSIN', 'role': 'CONTACT', 'email': 'DRCI-Promotion-Interne@chu-angers.fr', 'phoneExt': '+33241356147'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Angers', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}