[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100546559":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":22,"centralContacts":27,"locations":36,"responsibleParty":58,"collaborators":60,"id":66,"slug":67,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":70,"acronym":71,"eligibilityCriteria":72,"healthyVolunteers":73,"sex":74,"minAge":75,"maxAge":76,"enrollmentInfo":77,"targetDuration":10,"studyType":80,"phases":10,"briefSummary":81,"conditions":82,"keywords":86,"overallStatus":38,"whyStopped":10,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":112},{"fullName":5,"class":6},"Danish Research Centre for Magnetic Resonance","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Typically developing infants",null,"Born after gestational week 37, Uneventful birth, No known history of brain injury, No known neurological disorders",[13],"Other: No intervention, observational",{"label":15,"type":10,"description":16,"interventionNames":17},"High Risk for Cerebral Palsy","Recruitment through CP-EDIT (Clinical trials.gov ID: NCT05835674), inclusion criteria.\n\n'Newborn-detectable risk-pathway'. Preterm birth with gestational age below 32 or birth weight below 1500 g and clinical concern, Moderate to severe brain injury (Papile grade 3 to 4 intraventricular haemorrhage, cystic periventricular leukomalacia, neonatal stroke, term hypoxic-ischaemic encephalopathy (≥35 weeks gestation at birth) or other significant neurological condition), History (e.g. neonatal seizures, Extra Corporal Membrane Oxygenation, meningitis, kernicterus, severe hypoglycemia) or neurological risk factors (brain malformation, increased tone), Parental concern and one of the factors above\n\n'Infant detectable risk-pathway'. Inability to sit independently by age 9 months, Hand function asymmetry or crawl asymmetry, Inability to take weight through the plantar surface of the feet, History (as above) or neurological risk factors, Parental concern and one of the factors above.",[13],[19],{"type":6,"name":20,"description":20,"armGroupLabels":21,"otherNames":10},"No intervention, observational",[15,9],[23],{"name":24,"affiliation":25,"role":26},"Kathrine Skak Madsen, PhD","Senior Researcher","PRINCIPAL_INVESTIGATOR",[28,33],{"name":29,"role":30,"phone":31,"phoneExt":10,"email":32},"Line K Johnsen, PhD","CONTACT","+4561145571","linekj@drcmr.dk",{"name":24,"role":30,"phone":34,"phoneExt":10,"email":35},"+45 38623323","kathrine@drcmr.dk",[37],{"facility":5,"status":38,"city":39,"state":40,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"RECRUITING","Hvidovre","Capital Region","2650","Denmark","DK",{"type":45,"coordinates":46},"Point",[47,48],12.47708,55.64297,{"lat":48,"lon":47},[51,52,53,54,57],{"name":29,"role":30,"phone":10,"phoneExt":10,"email":32},{"name":24,"role":30,"phone":34,"phoneExt":10,"email":35},{"name":24,"role":26,"phone":10,"phoneExt":10,"email":10},{"name":55,"role":56,"phone":10,"phoneExt":10,"email":10},"Melanie Ganz-Benjaminsen, PhD","SUB_INVESTIGATOR",{"name":29,"role":56,"phone":10,"phoneExt":10,"email":10},{"type":59,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[61,63],{"name":62,"class":6},"Hvidovre University Hospital",{"name":64,"class":65},"Department of Pediatrics and Adolescent Medicine, Rigshospitalet, Denmark","UNKNOWN","100546559","neuroimaging-of-babies-during-natural-sleep-to-assess-typical-development-and-cerebral-palsy-100546559",false,"NCT06396520","Neuroimaging of Babies During Natural Sleep to Assess Typical Development and Cerebral Palsy","NIBS-CP","Inclusion Criteria High-Risk population:\n\nGroup: 'Newborn-detectable risk-pathway'\n\n* Preterm birth with gestational age below 32 weeks\n* Birth weight below 1500 g\n* Moderate to severe brain injury (A label of moderate to severe brain injury was considered if there was Papile grade three to four intraventricular haemorrhage, cystic periventricular leukomalacia, neonatal stroke, term hypoxic-ischaemic encephalopathy (≥35 weeks gestation at birth) or other significant neurological condition)\n* History (e.g., neonatal seizures, ECMO, meningitis, kernicterus, severe hypoglycemia) or neurological risk factors (malformations in CNS, increased tone)\n\nGroup: 'Infant detectable risk-pathway'\n\n* Inability to sit independently by age 9 months\n* Hand function asymmetry or crawl asymmetry\n* Inability to take weight through the plantar surface of the feet\n* History (e.g., as above) or neurological risk factors\n\nAdditional inclusion criteria for inclusion in NIBS-CP for both CP-risk groups:\n\n\\- Consent to health-relevant information on clinical findings being passed on to the medical doctors in CP-EDIT and\u002For their primary care physician.\n\nInclusion Criteria Typically developing infant population:\n\n* Born \\>37 weeks\n* Uneventful birth\n* No known history of brain injury\n* No neurological condition\n* Consent to health-relevant information on clinical findings being passed on to their primary care physician or relevant medical doctors, e.g., neuropaediatrician.\n\nExclusion Criteria (all groups):\n\n* Infants have any MRI contraindications, e.g., pacemaker or other implanted electronic devices.\n* Families do not speak or understand Danish.\n* Families do not wish to be informed about incidental findings on the MRI, or scores within the clinical range in the neurological, motor, or cognitive assessments.",true,"ALL","2 Months","11 Months",{"count":78,"type":79},200,"ESTIMATED","OBSERVATIONAL","Background: Early diagnosis of cerebral palsy (CP) is crucial, enabling intervention when neuroplasticity is at its highest. Magnetic resonance imaging (MRI) plays a vital role in CP diagnosis. Currently, diagnostic MRI of newborns and infants with suspected brain damage relies heavily on structural MR images. The current study aims to i) establish procedures for clinical infant and toddler MRI during natural sleep, ii) use advanced MRI sequences, such as advanced diffusion-weighted imaging (DWI), that may be more sensitive in detecting early brain damage, and iii) map relationships between early brain development, and motor function and development.\n\nMethods: The NIBS-CP study will enroll approximately 200 infants either at risk for CP or typically developing. Infants will be followed longitudinally (for three waves) between 3 months and 2 years of age with cerebral MRI at 3 Tesla and comprehensive assessments of motor and cognitive functioning. The MRI protocol includes advanced diffusion-weighted imaging, high-resolution structural MRI, and MR spectroscopy. The motor and cognitive assessments include Hand Assessment in Infants, Alberta Infant Motor Scales, Hammersmith Infant Neurological Examination, Peabody Developmental Motor Scales, Bayley Scales of Infant Development, and Ages and Stages Questionnaires. NIBS-CP aims to establish normative material on early brain development of Danish children and conduct normative modeling of typical and atypical development to identify deviations in brain development at the level of the single child.\n\nDiscussion: Identifying predictive brain structural features of motor function and motor development is key to the future use of early MRI in the clinical work-up, as this promotes early diagnosis and (clinical) intervention strategies tailored to the individual child.",[83,84,85],"Cerebral Palsy","Infant Development","Development, Infant",[87,88,89,90,91,92,93,94,95,83,96,97,98,99,100,101,102],"MRI","Brain development","Diffusion MRI","Motor development","Cognitive development","Normative modelling","Hand assessment for infants","Alberta Infant Motor scale","Motor functioning","Typically developing","Infants","Toddlers","Children","Peabody Developmental Motor Scales","Corticospinal tract","Motor system","2026-01-27",{"date":105,"type":106},"2026-01-28","ACTUAL",{"date":108,"type":106},"2024-06-01",{"date":110,"type":79},"2027-12-31",{"name":5,"class":6},1]