[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100522832":3},{"organization":4,"outcomesModule":7,"designInfo":39,"detailedDescription":38,"studyPopulation":38,"armGroups":48,"interventions":61,"overallOfficials":38,"centralContacts":69,"locations":79,"responsibleParty":108,"collaborators":38,"id":111,"slug":38,"hasResults":112,"nctId":113,"briefTitle":114,"officialTitle":115,"acronym":38,"eligibilityCriteria":116,"healthyVolunteers":112,"sex":117,"minAge":118,"maxAge":119,"enrollmentInfo":120,"targetDuration":38,"studyType":123,"phases":124,"briefSummary":126,"conditions":127,"keywords":129,"overallStatus":82,"whyStopped":38,"lastUpdateSubmitDate":136,"lastUpdatePostDateStruct":137,"startDateStruct":140,"completionDateStruct":142,"leadSponsor":144,"locationsCount":145},{"fullName":5,"class":6},"St. Justine's Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":38},[9],{"measure":10,"description":11,"timeFrame":12},"Neurodevelopment","Recording with video and coding with Assessment of Behavioral Systems Organization (ABSO) (from Assessment of Preterm Infant Behavior (APIB))","36 weeks gestational age (GA)",[14,17,19,23,26,30,34],{"measure":10,"description":15,"timeFrame":16},"Cerebral discontinuity activity vs. activity with EEG","4 months and 18 months",{"measure":10,"description":18,"timeFrame":16},"Bayley-IIII (Questionnaire)",{"measure":20,"description":21,"timeFrame":22},"Parental Stress","Questionnaire - Parental Stress Scale - Neonatal Intensive Care Unit (NICU) (PSS:NICU) - 25 items with a 5-point Likert-type. Minimum value: 25, maximum value: 100. A higher score indicates higher parental stress.","Baseline before randomization and every week after until 36 weeks GA",{"measure":24,"description":25,"timeFrame":22},"Parental Anxiety","Questionnaire - State-Trait Anxiety Inventory (STAI) - 20 items with a 4-point Likert-type scale. Minimum value: 20; maximum value: 80. A higher score indicates higher anxiety.",{"measure":27,"description":28,"timeFrame":29},"Parental sensitivity","Recording through videos and coding with Welch Emotional Connection Screen (WECS) - 4 dimensions: mutual attraction, facial communication, vocal communication and sensitivity\u002Freciprocity are coded on a 9-point scale from 1 to 3. Minimum value 4; maximum value 12. Higher scores indicate a better mother-child emotional connection.","4 months ans 18 months",{"measure":31,"description":32,"timeFrame":33},"Milk production","Through diary","Every day in mL until study completion at infants' 36 weeks gestational age.",{"measure":35,"description":36,"timeFrame":37},"Milk consumption","Through charting","Total in mL until study completion at infants' 36 weeks gestational age.",null,{"allocation":40,"interventionModel":41,"interventionModelDescription":38,"primaryPurpose":42,"observationalModel":38,"timePerspective":38,"maskingInfo":43},"RANDOMIZED","PARALLEL","SUPPORTIVE_CARE",{"masking":44,"maskingDescription":38,"whoMasked":45},"DOUBLE",[46,47],"PARTICIPANT","OUTCOMES_ASSESSOR",[49,55],{"label":50,"type":51,"description":52,"interventionNames":53},"NeuroN-QI","EXPERIMENTAL","Randomized dyads in the experimental group will be asked to do at least one session weekly (ideally 3) skin-to-skin contact (SSC) lasting 2 hours until the age of 36 weeks. Auditory sensory stimulation by mothers or fathers (reading a book) will be carried out during the first 10 minutes during the SSC sessions. The SSC will be followed by a period of calm and rest of one hour during which the infants will rest in their incubator with breast milk's olfactory stimulation. Light and sound control will be done during the entire intervention.",[54],"Behavioral: NeuroN-QI",{"label":56,"type":57,"description":58,"interventionNames":59},"SSC alone","ACTIVE_COMPARATOR","Randomized dyads in the control group will be asked to do at least one session weekly (ideally 3) skin-to-skin contact (SPC) lasting 2 hours until the corrected age of 36 weeks. During these sessions, light and noise levels will not be controlled or accompanied of auditory stimulation. SSC periods will not be followed by a calm and rest period with a olfactory stimulation.",[60],"Behavioral: SSC alone",[62,66],{"type":63,"name":50,"description":64,"armGroupLabels":65,"otherNames":38},"BEHAVIORAL","Skin-to-skin contact (SSC) lasting 2 hours with an auditory sensory stimulation followed by a period of calm and rest of one hour during which the infants will rest in their incubator with breast milk's olfactory stimulation. Light and sound control will be done during the entire intervention.",[50],{"type":63,"name":56,"description":67,"armGroupLabels":68,"otherNames":38},"Skin-to-skin contact (SSC) lasting 2 hours",[56],[70,76],{"name":71,"role":72,"phone":73,"phoneExt":74,"email":75},"Marilyn Aita, Ph.D.","CONTACT","514-343-6111","51473","marilyn.aita@umontreal.ca",{"name":77,"role":72,"phone":38,"phoneExt":38,"email":78},"Kate St-Arneault, Ph.D (cand.)","kate.st-arneault.hsj@ssss.gouv.qc.ca",[80,97],{"facility":81,"status":82,"city":83,"state":84,"zip":85,"country":86,"countryCode":87,"cosmosGeoPoint":88,"geoPoint":93,"contacts":94},"CHU Sainte-Justine","RECRUITING","Montreal","Quebec","H3T 1C5","Canada","CA",{"type":89,"coordinates":90},"Point",[91,92],-73.58781,45.50884,{"lat":92,"lon":91},[95],{"name":96,"role":72,"phone":73,"phoneExt":74,"email":75},"Marilyn Aita",{"facility":98,"status":99,"city":83,"state":84,"zip":100,"country":86,"countryCode":87,"cosmosGeoPoint":101,"geoPoint":103,"contacts":104},"CUSM","NOT_YET_RECRUITING","H4A 3J1",{"type":89,"coordinates":102},[91,92],{"lat":92,"lon":91},[105],{"name":106,"role":72,"phone":38,"phoneExt":38,"email":107},"Jessica Duby","jessica.duby@mcgill.ca",{"type":109,"investigatorFullName":96,"investigatorTitle":110,"investigatorAffiliation":5,"oldNameTitle":38,"oldOrganization":38},"PRINCIPAL_INVESTIGATOR","Researcher","100522832",false,"NCT06087744","NeuroN-QI: An Intervention to Promote Preterm Infants' Neurodevelopment","Effects of a Parent-preterm Proximity and Calm Intervention (NeuroN-QI) on the Neurodevelopment of Preterm Infants: A Randomized Pragmatic Clinical Trial","Inclusion Criteria for preterm infants:\n\n* born between 24 and 33 6\u002F7 weeks GA;\n* ready for SSC\n\nInclusion criteria for mothers and fathers:\n\n* agree to do at least one SSC session\u002Fweek combined with 10 min of auditory stimulation until 36 weeks of GA of their preterm infant;\n* mothers express breast milk for their preterm infants\n\nFor twin births (twin pregnancies), fathers will also be invited to participate in the study, so that both infants can participate in the study.\n\nExclusion criteria for preterm infants:\n\n* congenital anomalies or genetic disorders\n* intraventricular hemorrhage \\> grade II\n* are small for GA defined as birth weight \\\u003C10th percentile\n* on postnatal day 19 (maximum days targeted for study start)\n* are still receiving analgesics, sedatives, paralyzing agents\n* are under mechanical ventilation\n\nExclusion criteria mothers and fathers:\n\n* are aged \\\u003C18 years;\n* have a physical condition that does not allow the SSC\n* abuse illicit substances or alcohol that could influence stress, anxiety and parent- child interactions\n* feed their preterm infant exclusively with commercial infant formula\n* mothers had a breast surgery that could influence their breast milk production\n* do not speak, read or write in French or in English","ALL","24 Weeks","34 Weeks",{"count":121,"type":122},124,"ESTIMATED","INTERVENTIONAL",[125],"NA","NeuroN-QI aims to evaluate the effects of an intervention consisting of periods of: 1) parents\u002Fpreterm infants skin-to-skin contact and auditory stimulation by the parents's voice and 2) calm without manipulation with olfactory stimulation with breast milk in the incubator\u002Fbed both combined with appropriate light and noise levels to promote neurodevelopment preterm infants.",[128],"Neurodevelopmental Disorders",[130,131,132,133,134,135],"NICU","skin to skin contact","neurodevelopment","preterm infants","positive stimulation","environmental control","2024-04-17",{"date":138,"type":139},"2024-04-19","ACTUAL",{"date":141,"type":139},"2023-11-23",{"date":143,"type":122},"2027-10",{"name":5,"class":6},2]