[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100605944":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":26,"locations":33,"responsibleParty":54,"collaborators":10,"id":56,"slug":57,"hasResults":58,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":62,"eligibilityCriteria":63,"healthyVolunteers":58,"sex":64,"minAge":65,"maxAge":66,"enrollmentInfo":67,"targetDuration":10,"studyType":70,"phases":10,"briefSummary":71,"conditions":72,"keywords":74,"overallStatus":79,"whyStopped":10,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},{"fullName":5,"class":6},"University Hospital, Toulouse","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"SPIN-NA Evaluation",null,"Infants evaluated by SPIN-NA grid",[13],"Other: SPIN-NA Developmental Observation Grid Assessment via Home-Based Standardized Video Recording",[15],{"type":6,"name":16,"description":17,"armGroupLabels":18,"otherNames":10},"SPIN-NA Developmental Observation Grid Assessment via Home-Based Standardized Video Recording","The SPIN-NA intervention consists of an analytical assessment of development using a standardized clinical observation grid.\n\nInfants are filmed at home once between 1 and 6 months of corrected age in their family environment by the creators of the grid.\n\nThe filmed observation includes structured observation scenarios designed to assess eight areas of development:\n\nstress signals, physiological and tonic regulation, perceptual abilities of different sensory channels, exploratory appetite, manipulative activities, child interactions and communication, emotional expressions and expressiveness, parent-child interactions: parental adaptation to the child's behavior.The videos are evaluated independently by five experienced psychomotor therapists trained together in the use of the SPINNA grid. No treatment or physical intervention is administered; the intervention is observational and non-invasive, aimed at validating the reproducibility of the grid in a real-world context.",[9],[20,24],{"name":21,"affiliation":22,"role":23},"Corine Alberge","University Hospital of Toulouse","STUDY_DIRECTOR",{"name":25,"affiliation":22,"role":23},"Nathalie Noack",[27],{"name":28,"role":29,"phone":30,"phoneExt":31,"email":32},"Nadège Algans","CONTACT","0561777204","+33","algans.n@chu-toulouse.fr",[34],{"facility":35,"status":10,"city":36,"state":10,"zip":37,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"Intensive care \u002Fneonatology Toulouse Hospital","Toulouse","31000","France","FR",{"type":41,"coordinates":42},"Point",[43,44],1.44367,43.60426,{"lat":44,"lon":43},[47,51],{"name":48,"role":29,"phone":49,"phoneExt":31,"email":50},"Corinne Alberge","33 6 23 81 09 77","alberge.c@chu-toulouse.fr",{"name":52,"role":53,"phone":10,"phoneExt":10,"email":10},"Alice Pincon","PRINCIPAL_INVESTIGATOR",{"type":55,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100605944","study-of-the-interprofessional-reproducibility-of-a-clinical-observation-scale-for-the-development-of-very-premature-infants-100605944",false,"NCT07169110","Study of the Interprofessional Reproducibility of a Clinical Observation Scale for the Development of Very Premature Infants","Study of the Interprofessional Reproducibility of a Clinical Observation Scale for the Development of Very Premature Infants Aged 1 to 6 Months Corrected, for the Very Early Detection of Developmental Disorders.","SPIN-NA","Inclusion Criteria:\n\n* Male or female child born between 27 and 32 weeks of amenorrhea in a singleton pregnancy;\n* Child hospitalized in the neonatology unit of Toulouse University Hospital;\n* Family home within a 15 km radius of Toulouse to allow for home visits for filming;\n* Parents with parental authority affiliated with a social security scheme or equivalent;\n* Signature of the informed consent form by the parents with parental authority\n* Absence of serious illness, as defined in the exclusion criteria;\n* The child may participate in another study during the duration of this study, without an exclusion period.\n\nExclusion Criteria:\n\n* Child with a severe organic pathology detected during hospitalization and requiring specific and appropriate care for the diagnosed pathology;\n* Child with a neurological complication: Grade 3 or 4 intraventricular hemorrhage, periventricular cavitary leukomalacia, excluding frontal leukomalacia;\n* Child with a malformation or multiple malformations that impair the neurological prognosis;\n* Child with genetic or metabolic diseases;\n* Fetal alcohol syndrome;\n* Parental authority holders under guardianship, curatorship, or legal protection;\n* Any family condition that prevents compliance with the procedures set out in the study protocol, in the opinion of the investigator.\n* Family members who do not speak French fluently, in order to ensure understanding of the system and the proposed care.","ALL","1 Month","6 Months",{"count":68,"type":69},35,"ESTIMATED","OBSERVATIONAL","The research concerns the study of the interprofessional reproducibility of a grid for observing the development of premature infants from 1 to 6 months corrected age. No tool is available to characterize the mechanisms of early developmental processes and their deviations. We propose an analytical observation grid of developmental mechanisms in the first few months, in order to identify warning signs of developmental deviations and help define the nature and type of early care for vulnerable infants.",[73],"Prematurity",[75,76,77,78],"Premature infant","early development","early care intervention","early evaluation","NOT_YET_RECRUITING","2025-12-11",{"date":82,"type":83},"2025-12-18","ACTUAL",{"date":85,"type":69},"2025-12-22",{"date":87,"type":69},"2026-12-30",{"name":5,"class":6},1]