[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100634693":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":10,"centralContacts":15,"locations":24,"responsibleParty":41,"collaborators":10,"id":43,"slug":44,"hasResults":45,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":51,"sex":52,"minAge":10,"maxAge":53,"enrollmentInfo":54,"targetDuration":10,"studyType":57,"phases":10,"briefSummary":58,"conditions":59,"keywords":61,"overallStatus":26,"whyStopped":10,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":75},{"fullName":5,"class":6},"University of Oxford","OTHER",[8,12],{"label":9,"type":10,"description":11,"interventionNames":10},"Test cohort",null,"Children with spinal muscular atrophy, identified by newborn screening and treated with DMT or diagnosed after birth due to affected sibling and treated with DMT or 4 copies of SMN2 and not treated. Patients between 4 months and 4 years at the baseline visit, inclusion of patients can be before 4 months of age.",{"label":13,"type":10,"description":14,"interventionNames":10},"Control cohort","Typically developing children below 4 years of age between 6 months and 4 years of age at inclusion.",[16,21],{"name":17,"role":18,"phone":19,"phoneExt":10,"email":20},"Charlotte Lilien","CONTACT","01865618799","charlotte.lilien@paediatrics.ox.ac.uk",{"name":22,"role":18,"phone":10,"phoneExt":10,"email":23},"Active-NBS Joint Mailbox","active.nbs@paediatrics.ox.ac.uk",[25],{"facility":5,"status":26,"city":27,"state":10,"zip":28,"country":29,"countryCode":30,"cosmosGeoPoint":31,"geoPoint":36,"contacts":37},"RECRUITING","Oxford","OX3 9DU","United Kingdom","UK",{"type":32,"coordinates":33},"Point",[34,35],-1.25596,51.75222,{"lat":35,"lon":34},[38,39],{"name":17,"role":18,"phone":19,"phoneExt":10,"email":20},{"name":40,"role":18,"phone":10,"phoneExt":10,"email":23},"Joint inbox",{"type":42,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100634693","an-international-federated-model-for-wearable-derived-remote-longitudinal-motor-monitoring-in-young-children-with-spinal-muscular-atrophy-compared-with-healthy-controls-active-nbs-study-uk-100634693",false,"NCT07543003","An International Federated Model for Wearable-derived Remote Longitudinal Motor Monitoring in Young Children With Spinal Muscular Atrophy Compared With Healthy Controls: Active-NBS Study (UK)","A Prospective, Longitudinal and Decentralised Study Investigating the Motor Development of Patients With Spinal Muscular Atrophy Identified by Newborn Screening Age 4 Years and Below: Active-NBS UK.","Active-NBS UK","Inclusion criteria (Test cohort):\n\n1. Genetically confirmed SMA and number of SMN2 copies available\n2. a. Patients identified by NBS and treated with disease modifying therapy (DMT)\n\n(2)a,i 4 copies or more of SMN2 and not treated with DMT\n\n(2)a,ii less than 4 copies of SMN2 and not treated with DMT\n\nor\n\n(2)b. Patients diagnosed due to a sibling or alternative means\n\n(2)b,i 4 copies or more of SMN2 and not treated with DMT\n\n(2)b,ii less than 4 copies of SMN2 and not treated with DMT\n\n(3)Patients between 4 months and below 4 years at baseline. Inclusion of patients can be before 4 months of age\n\n(4)Parent(s)\u002Flegal guardian(s) able to provide written informed consent prior to the patient's participation in the study\n\n(5)Male or female\n\nExclusion Criteria (Test cohort):\n\n1. Any acute or chronic condition which, according to the investigator, significantly interferes with the assessments and\u002For the motor evolution\n2. Currently enrolled in an experimental treatment study\n\nInclusion criteria (Control):\n\n1. Typically developing child\n2. Participant between 6 months and 4 years at inclusion\n3. Parent(s)\u002Flegal guardian(s) able to provide written informed consent prior to the participation in the study\n4. Male or female\n\nExclusion criteria (Control):\n\n(1)Any acute or chronic condition which, according to the investigator, significantly interferes with the assessments and\u002For the motor evolution",true,"ALL","4 Years",{"count":55,"type":56},90,"ESTIMATED","OBSERVATIONAL","Active-NBS is a study to evaluate the muscle development of patients with spinal muscular atrophy (SMA) who are diagnosed at birth.\n\nMedicines have become available in the last decade, and many patients are treated very early. Treatments are most effective if used before the patient develops symptoms. However, some patients may show symptoms by the time they receive treatment. This means that even with early diagnosis, they might still develop muscle weakness despite treatment. The investigators want to see when the movements of patients diagnosed at birth differ from normal development. This information will help identify the best time to give additional medicines currently being developed to support the muscle.\n\nThe investigators will track the progress of up to 60 patients over a maximum of 30 months using wearable technologies which are worn at home. The investigators aim to validate their outcomes for use in this age group. The wearable devices are called Syde and Motor Assessment of an Infant in a Jumpsuit (MAIJU).\n\nThey will be worn at regular intervals during the study and will not involve extra hospital visits for patients. The study will also recruit up to 30 healthy control participants and follow them for up to 30 months. This will help define normal development with use of the Syde device.\n\nActive-NBS will be conducted in the UK and internationally using a federated data model. Collaborative sites will collect harmonised data in accordance with the Active-NBS protocol, with data integration and oversight managed by the University of Oxford. International sites may contact the Oxford study team to establish collaboration.",[60],"Spinal Muscular Atrophy (SMA)",[62,63,64,65],"Spinal muscular atrophy","Newborn screening","Motricity","Development","2026-05-06",{"date":68,"type":69},"2026-05-11","ACTUAL",{"date":71,"type":69},"2026-05-01",{"date":73,"type":56},"2029-07",{"name":5,"class":6},1]