Ignite Creation Date:
2025-12-24 @ 11:49 PM
Ignite Modification Date:
2025-12-30 @ 11:03 AM
Study NCT ID:
NCT04380051
Status:
RECRUITING
Last Update Posted:
2024-12-18
First Post:
2020-05-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of a Sensory-tonic Stimulation on Development of Parent-infant Interactions and Social Cognition in Very Premature Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'participants are assigned to one of two or more groups in parallel for the duration of the study'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-01-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2033-01-19', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-17', 'studyFirstSubmitDate': '2020-05-05', 'studyFirstSubmitQcDate': '2020-05-05', 'lastUpdatePostDateStruct': {'date': '2024-12-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-01-19', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'interactions between parents and child', 'timeFrame': '12 months', 'description': 'Two free play sequences of 15 minutes will be filmed. The Coding Interactive Behavior (CIB; Feldman, 1998) contains 43 items (22 relating to parents, 16 relating to child and 5 related to parent-child dyad. Each item is rated from 1 (a little) to 5 (a lot). The Coding Interactive Behavior has 6 dimensions. The dimension "social commitment of the child" will be the primary outcome for this study.'}], 'secondaryOutcomes': [{'measure': 'Social cognition / Theory of mind', 'timeFrame': '6 years', 'description': 'small stories involving the thinking and feelings of character'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Very Preterm Birth']}, 'referencesModule': {'references': [{'pmid': '36727004', 'type': 'DERIVED', 'citation': 'Guittard C, Novo A, Eutrope J, Gower C, Barbe C, Bednarek N, Rolland AC, Caillies S, Loron G. Protocol for a prospective multicenter longitudinal randomized controlled trial (CALIN) of sensory-tonic stimulation to foster parent child interactions and social cognition in very premature infants. Front Pediatr. 2023 Jan 16;10:913396. doi: 10.3389/fped.2022.913396. eCollection 2022.'}]}, 'descriptionModule': {'briefSummary': "Attachment is built primarily on the first interactions of the first 9 months of a baby's life. These first interactions and their effects of stress, pleasure and displeasure are retained to establish some of the baby's attachment behaviours and future relationships with others.\n\nExtreme prematurity strongly modify these first interactions between parents and child. Very preterm child is separated from his parents and is placed in a stressful, technical and potentially painful environment.\n\nEarly interventions stimulate neuroplasticity and can positively affect the neurological development of very preterm infant. Tactile stimuli such as skin-to-skin contact and massages carried out by parents can be pleasant experiences that can support early interactions between parents and child.", 'detailedDescription': 'The aim of the study is to evaluate impact of a sensory-tonic stimulation on development of parent-infant interaction and on social cognition in very premature children.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '1 Day', 'healthyVolunteers': False, 'eligibilityCriteria': 'inclusion criteria :\n\n* very preterm child (born before 32 weeks of amenorrhoea)\n* parents agreeing to participate to the study\n\nexclusion criteria :\n\n* child born before 25 weeks of amenorrhoea\n* child with a birth weight less than 600 grams\n* child with congenital malformation\n* child with hemodynamic instability'}, 'identificationModule': {'nctId': 'NCT04380051', 'acronym': 'CALIN', 'briefTitle': 'Evaluation of a Sensory-tonic Stimulation on Development of Parent-infant Interactions and Social Cognition in Very Premature Children', 'organization': {'class': 'OTHER', 'fullName': 'CHU de Reims'}, 'officialTitle': 'Evaluation of a Sensory-tonic Stimulation on Development of Parent-infant Interaction and Social Cognition in Very Premature Children', 'orgStudyIdInfo': {'id': 'PR20064*'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm 1 : skin-to-skin contact associated with a sensory-tonic s', 'description': 'skin-to-skin contact left free for parents associated with a sensory-tonic stimulation five times a week during 15 minutes at each time', 'interventionNames': ['Behavioral: sensory-tonic stimulation', 'Behavioral: skin-to-skin contact']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Arm 2 : skin-to-skin contact only', 'description': 'skin-to-skin contact left free for parents', 'interventionNames': ['Behavioral: skin-to-skin contact']}], 'interventions': [{'name': 'sensory-tonic stimulation', 'type': 'BEHAVIORAL', 'description': 'sensory-tonic stimulation done by the parents to the child, five times a week during 15 minutes at each time', 'armGroupLabels': ['Arm 1 : skin-to-skin contact associated with a sensory-tonic s']}, {'name': 'skin-to-skin contact', 'type': 'BEHAVIORAL', 'description': 'skin-to-skin contact left free for parents', 'armGroupLabels': ['Arm 1 : skin-to-skin contact associated with a sensory-tonic s', 'Arm 2 : skin-to-skin contact only']}]}, 'contactsLocationsModule': {'locations': [{'zip': '51092', 'city': 'Reims', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Damien JOLLY', 'role': 'CONTACT', 'email': 'djolly@chu-reims.fr', 'phone': '326788472', 'phoneExt': '33'}], 'facility': 'Chu Reims', 'geoPoint': {'lat': 49.26526, 'lon': 4.02853}}], 'centralContacts': [{'name': 'Gauthier Loron', 'role': 'CONTACT', 'email': 'gloron@chu-reims.fr', 'phone': '0326787878'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CHU de Reims', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}