[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100625122":3},{"organization":4,"armGroups":7,"interventions":34,"overallOfficials":40,"centralContacts":49,"locations":55,"responsibleParty":71,"collaborators":10,"id":75,"slug":76,"hasResults":77,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":10,"eligibilityCriteria":81,"healthyVolunteers":82,"sex":83,"minAge":84,"maxAge":85,"enrollmentInfo":86,"targetDuration":10,"studyType":89,"phases":10,"briefSummary":90,"conditions":91,"keywords":95,"overallStatus":57,"whyStopped":10,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":114},{"fullName":5,"class":6},"Laboratory of Psychological and Educational Tests","OTHER_GOV",[8,14,18,22,26,30],{"label":9,"type":10,"description":11,"interventionNames":12},"Control Group",null,"Children without identified developmental delays, genetic conditions, or major perinatal complications, assessed as part of the general population.",[13],"Diagnostic Test: Psychological developmental assessment",{"label":15,"type":10,"description":16,"interventionNames":17},"Developmental Delay","Children with identified developmental delay based on prior clinical assessment or referral information, without a confirmed specific genetic diagnosis.",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Genetic Conditions","Children with confirmed genetic conditions associated with developmental risk, based on medical documentation provided by parents or caregivers.",[13],{"label":23,"type":10,"description":24,"interventionNames":25},"Moderate to Late Preterm","Children born preterm between 33 and 37 weeks of gestational age. This group includes infants and toddlers with a history of moderate to late prematurity, without severe neonatal complications requiring classification as extremely preterm.",[13],{"label":27,"type":10,"description":28,"interventionNames":29},"Extremely Preterm","Children born before 33 weeks of gestational age. This group includes infants and toddlers with a history of extreme prematurity, associated with increased risk for developmental difficulties across multiple domains.",[13],{"label":31,"type":10,"description":32,"interventionNames":33},"Cerebral Palsy","Children with a diagnosis of cerebral palsy documented in medical records. This group includes children with motor impairment of neurological origin, potentially accompanied by cognitive, language, or adaptive difficulties.",[13],[35],{"type":36,"name":37,"description":38,"armGroupLabels":39,"otherNames":10},"DIAGNOSTIC_TEST","Psychological developmental assessment","All participants undergo a standardized psychological developmental assessment conducted by trained specialists. The assessment includes structured diagnostic tasks and direct observation of the child's behavior during play and natural interaction, carried out in the presence of a parent or legal guardian. In addition, parents or caregivers complete standardized questionnaires assessing the child's social-emotional functioning and adaptive behavior. No experimental intervention or therapeutic procedure is applied.",[31,9,15,27,19,23],[41,44,47],{"name":42,"affiliation":5,"role":43},"Urszula Sajewicz-Radtke, Ph.D.","PRINCIPAL_INVESTIGATOR",{"name":45,"affiliation":5,"role":46},"Bartosz M Radtke, Ph.D.","STUDY_DIRECTOR",{"name":48,"affiliation":5,"role":43},"Ariadna Łada-Maśko, Ph.D.",[50],{"name":51,"role":52,"phone":53,"phoneExt":10,"email":54},"Rafał Nowicki, M.A.","CONTACT","+48509805591","nowicki@pracowniatestow.pl",[56],{"facility":5,"status":57,"city":58,"state":59,"zip":60,"country":61,"countryCode":62,"cosmosGeoPoint":63,"geoPoint":68,"contacts":69},"RECRUITING","Gdansk","Pomeranian Voivodeship","80-239","Poland","PL",{"type":64,"coordinates":65},"Point",[66,67],18.64912,54.35227,{"lat":67,"lon":66},[70],{"name":51,"role":52,"phone":53,"phoneExt":10,"email":54},{"type":72,"investigatorFullName":73,"investigatorTitle":74,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"SPONSOR_INVESTIGATOR","Bartosz M. Radtke","PhD","100625122","understanding-early-development-of-infants-and-toddlers-100625122",false,"NCT07418528","Understanding Early Development of Infants and Toddlers","Understanding Early Development: A Biopsychosocial Perspective on Infant and Toddler Functioning","Inclusion Criteria:\n\n* Infants and young children aged from 16 days to 42 months at the time of assessment.\n* Participation of a parent or legal guardian able to provide informed consent.\n* Child's ability to participate in a standardized developmental assessment appropriate for age and developmental level.\n* Availability of basic medical and perinatal information provided by parents or caregivers.\n* Assignment to one of the predefined study cohorts based on medical history and developmental status:\n\nchildren from the general population (control group), children with developmental delay, children with confirmed genetic conditions, children born preterm between 33 and 37 weeks of gestation, children born before 33 weeks of gestation, children with a diagnosis of cerebral palsy.\n\nExclusion Criteria:\n\n* Severe acute medical condition at the time of assessment preventing participation in the psychological evaluation.\n* Uncorrected severe sensory impairments (e.g., profound visual or hearing impairment) that preclude valid administration or interpretation of the developmental assessment.\n* Medical instability or conditions requiring immediate intensive medical care.\n* Lack of informed consent from a parent or legal guardian.\n* Inability of the parent or caregiver to provide reliable information required for questionnaire-based assessment.",true,"ALL","16 Days","42 Months",{"count":87,"type":88},1200,"ESTIMATED","OBSERVATIONAL","The goal of this observational study is to analyze early development in infants and young children from a biopsychosocial perspective, with a particular focus on cognitive, language, motor, social-emotional, and adaptive functioning during the first years of life.\n\nThe study will include infants and young children from 16 days of age up to 42 months of age, assessed during a single diagnostic session conducted by qualified specialists. The developmental assessment will include standardized diagnostic tasks and direct observation of behavior in the form of play and natural interaction, carried out in the presence of a parent or legal guardian.\n\nIn addition, information regarding the child's everyday functioning will be collected from parents or caregivers using standardized questionnaires, including data on social-emotional competencies, communication, and adaptive skills.\n\nThe main research questions addressed by this study are:\n\nWhat is the developmental profile of infants and young children in the first years of life?\n\nWhat relationships exist between different domains of early development within a biopsychosocial model of child functioning?\n\nCan specific developmental patterns be identified that indicate an increased risk of developmental difficulties in early childhood?\n\nHow does age differentiate the structure and variability of developmental functioning across assessed domains?\n\nThe study is non-invasive and observational in nature. Data will be analyzed exclusively in aggregated form and will contribute to a better understanding of early child development as well as to the development of norms and tools supporting early diagnosis and developmental intervention.",[92,93,94],"Early Childhood Development","Infant Development","Child Development",[96,97,98,99,100,101,102,103,104],"Early development","Infant development","Toddler development","Neurodevelopment","Cognitive development","Language development","Motor development","Social-emotional development","Adaptive behavior","2026-02-19",{"date":107,"type":108},"2026-02-23","ACTUAL",{"date":110,"type":108},"2025-01-02",{"date":112,"type":88},"2027-03",{"name":73,"class":6},1]