[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100564368":3},{"organization":4,"outcomesModule":7,"designInfo":45,"detailedDescription":53,"studyPopulation":50,"armGroups":54,"interventions":64,"overallOfficials":50,"centralContacts":70,"locations":79,"responsibleParty":193,"collaborators":50,"id":195,"slug":50,"hasResults":196,"nctId":197,"briefTitle":198,"officialTitle":199,"acronym":200,"eligibilityCriteria":201,"healthyVolunteers":196,"sex":202,"minAge":203,"maxAge":204,"enrollmentInfo":205,"targetDuration":50,"studyType":208,"phases":209,"briefSummary":211,"conditions":212,"keywords":214,"overallStatus":82,"whyStopped":50,"lastUpdateSubmitDate":220,"lastUpdatePostDateStruct":221,"startDateStruct":224,"completionDateStruct":226,"leadSponsor":228,"locationsCount":229},{"fullName":5,"class":6},"Region Skane","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":21,"otherOutcomes":30},[9,13,17],{"measure":10,"description":11,"timeFrame":12},"Safety of the guidelines","The number of wrongful and missed diagnoses (definition: managed and diagnosed as breath-holding spells at physician assessment within study but later found to be another cause for the symptoms, like long QT syndrome or epilepsy).","From date of inclusion to end of follow up at 36 months",{"measure":14,"description":15,"timeFrame":16},"Usability of the guidelines","Assessed according to the following:\n\n* Number of patients with a diagnostic interventions for each intervention in the guidelines: ECGs and bloodtests.\n* Number of found pathologies for each intervention (blood tests and ECGs) - for patients with typical spells handled according to the guidelines and those with non-typical spells managed individually. This includes a retrospective assessment of ECG (a complete assessment including rythm, long QT syndrome, AV-block, ST-segment changes) and blood test results (for anemia and iron deficiency; i.e. values outside of the age adapted normal range).\n* Retrospective analysis of the clinical doctors compliance with managment guidelines, evaluated through the number of interventions for each patient that were not recommended in the guidlines (for instance number of EEGs).","From date of inclusion until last diagnostic intervention, expected to be within 2 weeks from inclusion.",{"measure":18,"description":19,"timeFrame":20},"Usability of the disease definition","Assessed according to the following:\n\n* Adherence to the the prespecified definition of typical spells through comparison of clinical physicians assessment and a retrospective assessment by study physician, i.e. the number of cases with a discrepant judgment of the clinical presentation.\n* The number of typical spells compared to the number of non-typical spells and other diagnsoses.\n* Compilation of patient and spell characteristics (defined in the variable list in the attached documents) and comparison with the current definition of typical spells.","From the inclusion date until end of physicians assessment",[22,26],{"measure":23,"description":24,"timeFrame":25},"Need of information and support to parents","Through interview study (qualitative study) gather information on given information and support and their need for more information and support. Will be conducted on parents of children with more than 5 spells in total at the 6 month follow up (assessed as frequent spells).","From 6 months after inclusion until interview is performed (expected to be within three months of six month digital survey)",{"measure":27,"description":28,"timeFrame":29},"Effect of iron supplement treatment on spell frequency and severity","In cases of iron treatment (initiated by the clinical physician). Assessed according to the following:\n\n* Comparison of spell frequency (number of spells\u002Ftime unit) before start of treatment, during treatment and after completion of treament.\n* Comparison of spell severity (simple or severe spells defined as spells without and with loss of consciousness) before start of treatment, during treatment and after completion of treament.\n* Anemia and iron deficiency blood test values (Hb, MCV, reticulocytes, ferritin, CRP if signs of infection, iron, iron saturation and transferrin) comparison between patients with effect of iron treatment on spell frequency and severity, versus the group without a clinical effect of iron treatment.\n* Patient compliance for iron supplementation as per survey question with answer altneratives yes\u002Fno\u002Fdon't know","From the date of inclusion until evaluation of iron treatment, most probably within 12 months from inclusion.",[31,35,38,41],{"measure":32,"description":33,"timeFrame":34},"Natural course of the spells through long term follow-up","Assessed according to the following parameters, through digital surveys:\n\n* Spells during the last 3 months (yes or no)\n* Number of spells the previous month (0, 1, 2-5, 6-10, \\>10)\n* Total number of spells (free text)\n* Uncontactable or unconscious (=severity of spells) (Yes, No, Don't know)\n* Alterations in spell semiology? (Yes, No, Don't know)","36 months",{"measure":36,"description":37,"timeFrame":34},"Contact with health care during long term follow-up","Evaluation of the following questions:\n\n1. Do parents follow the advice to reach out to health care if the spell semiology change?\n2. Planned follow up?\n\nAbove questions are assessed in a digital survey:\n\n\\- Further contact with healthcare. Answer alternatives: (Yes, No, Don't know). If yes: (acute or planned)",{"measure":39,"description":40,"timeFrame":34},"Burden of care","Will be assessed through a combined evaluation of the following variables:\n\n* Number of acute health care visits\n* Number of planned health care visits including follow-up appointments over phone\n* Number of over-night hospital stays (number of nights)\n* Number of ambulance rides to the hospital",{"measure":42,"description":43,"timeFrame":44},"Dietary impact on iron status","At first visit, parents will answer questions on the child and family's diet in a questionnaire, to evaluate a possible association between diet and iron status (and further, to breath-holding spell frequency and severity).\n\nThe questions are as follows:\n\n* Mark all alternatives that is correct about your childs diet: (breatmilk\u002Fformula\u002Fcow's milk\u002Ftaste portions\u002Ffamily meals)\n* Does your child drink more than 3 dl of cow's milk per day? (yes\u002Fno)\n\n  \\> If yes, estimate the amount of cow's milk your child drink during a day in dl: (a number in free text)\n* Do you eat vegetarian or vegan food only? (yes\u002Fno)","From inclusion to blood test results, within 2 weeks from initial visit",{"allocation":46,"interventionModel":47,"interventionModelDescription":48,"primaryPurpose":49,"observationalModel":50,"timePerspective":50,"maskingInfo":51},"NON_RANDOMIZED","PARALLEL","Inclusion upon suspicion of Breath Holding Spell. Thereafter, allocation to either the group that has a defined typical Breath Holding spell, or the alternative (parallel) group that is not diagnosed with a typical Breath Holding Spell. Subsequent management of study subject in the Typical Breath Holding Spell group according to the management algorithm.","DIAGNOSTIC",null,{"masking":52,"maskingDescription":50,"whoMasked":50},"NONE","Please see the Study plan among the documents.",[55,60],{"label":56,"type":6,"description":57,"interventionNames":58},"Typical spells","Patients with typical spells should be investigated according to our guidelines",[59],"Diagnostic Test: Guidelines",{"label":61,"type":62,"description":63,"interventionNames":50},"Non-typical spells","NO_INTERVENTION","Patients with non-typical spells will be investigated individually, as it is done today",[65],{"type":66,"name":67,"description":68,"armGroupLabels":69,"otherNames":50},"DIAGNOSTIC_TEST","Guidelines","Participant with typical spells will be investigated according to our guidelines. These include that participants with heredity for or signs and symptoms of cardiac disease will be subjected to an ECG and participants with two or more spells should be subjected to blood tests for anemia and iron deficiency",[56],[71,76],{"name":72,"role":73,"phone":74,"phoneExt":50,"email":75},"Sanna Hellström Schmidt, MD","CONTACT","+4646177203","sanna.hellstrom_schmidt@med.lu.se",{"name":77,"role":73,"phone":50,"phoneExt":50,"email":78},"Cornelis J Pronk, MD, PhD","kees-jan.pronk@med.lu.se",[80,95,106,117,124,133,141,148,155,161,172,183],{"facility":81,"status":82,"city":83,"state":50,"zip":50,"country":84,"countryCode":85,"cosmosGeoPoint":86,"geoPoint":91,"contacts":92},"Barn- och ungdomsmedicinmottagning Eslöv","RECRUITING","Eslöv","Sweden","SE",{"type":87,"coordinates":88},"Point",[89,90],13.30393,55.83928,{"lat":90,"lon":89},[93],{"name":94,"role":73,"phone":50,"phoneExt":50,"email":50},"Annika Lagström",{"facility":96,"status":82,"city":97,"state":50,"zip":50,"country":84,"countryCode":85,"cosmosGeoPoint":98,"geoPoint":102,"contacts":103},"Capio Barnavårdscentral Kristianstad","Kristianstad",{"type":87,"coordinates":99},[100,101],14.15242,56.03129,{"lat":101,"lon":100},[104],{"name":105,"role":73,"phone":50,"phoneExt":50,"email":50},"Linda Nyberg",{"facility":107,"status":82,"city":108,"state":50,"zip":50,"country":84,"countryCode":85,"cosmosGeoPoint":109,"geoPoint":113,"contacts":114},"Barnläkargruppen Sparta","Lund",{"type":87,"coordinates":110},[111,112],13.19321,55.70584,{"lat":112,"lon":111},[115],{"name":116,"role":73,"phone":50,"phoneExt":50,"email":50},"Johanna Bengtsson",{"facility":118,"status":82,"city":108,"state":50,"zip":50,"country":84,"countryCode":85,"cosmosGeoPoint":119,"geoPoint":121,"contacts":122},"Skåne University Hospital",{"type":87,"coordinates":120},[111,112],{"lat":112,"lon":111},[123],{"name":72,"role":73,"phone":50,"phoneExt":50,"email":50},{"facility":107,"status":82,"city":125,"state":50,"zip":50,"country":84,"countryCode":85,"cosmosGeoPoint":126,"geoPoint":130,"contacts":131},"Malmö",{"type":87,"coordinates":127},[128,129],13.00073,55.60587,{"lat":129,"lon":128},[132],{"name":116,"role":73,"phone":50,"phoneExt":50,"email":50},{"facility":134,"status":82,"city":125,"state":50,"zip":50,"country":84,"countryCode":85,"cosmosGeoPoint":135,"geoPoint":137,"contacts":138},"BVC Bambino Hyllie",{"type":87,"coordinates":136},[128,129],{"lat":129,"lon":128},[139],{"name":140,"role":73,"phone":50,"phoneExt":50,"email":50},"Anna Sövgren",{"facility":142,"status":82,"city":125,"state":50,"zip":50,"country":84,"countryCode":85,"cosmosGeoPoint":143,"geoPoint":145,"contacts":146},"BVC Bambino Lindängen",{"type":87,"coordinates":144},[128,129],{"lat":129,"lon":128},[147],{"name":140,"role":73,"phone":50,"phoneExt":50,"email":50},{"facility":149,"status":82,"city":125,"state":50,"zip":50,"country":84,"countryCode":85,"cosmosGeoPoint":150,"geoPoint":152,"contacts":153},"BVC Bambino Mobilia",{"type":87,"coordinates":151},[128,129],{"lat":129,"lon":128},[154],{"name":140,"role":73,"phone":50,"phoneExt":50,"email":50},{"facility":118,"status":82,"city":125,"state":50,"zip":50,"country":84,"countryCode":85,"cosmosGeoPoint":156,"geoPoint":158,"contacts":159},{"type":87,"coordinates":157},[128,129],{"lat":129,"lon":128},[160],{"name":72,"role":73,"phone":50,"phoneExt":50,"email":50},{"facility":162,"status":82,"city":163,"state":50,"zip":50,"country":84,"countryCode":85,"cosmosGeoPoint":164,"geoPoint":168,"contacts":169},"Barn- och ungdomsmedicinmottagning Simrishamn, Capio närsjukhus","Simrishamn",{"type":87,"coordinates":165},[166,167],14.35037,55.55653,{"lat":167,"lon":166},[170],{"name":171,"role":73,"phone":50,"phoneExt":50,"email":50},"Therése Saksø",{"facility":173,"status":82,"city":174,"state":50,"zip":50,"country":84,"countryCode":85,"cosmosGeoPoint":175,"geoPoint":179,"contacts":180},"Familjecentralen Björken, BVC Sjöbo","Sjöbo",{"type":87,"coordinates":176},[177,178],13.70622,55.63135,{"lat":178,"lon":177},[181],{"name":182,"role":73,"phone":50,"phoneExt":50,"email":50},"Gustav Robertz, MD",{"facility":184,"status":82,"city":185,"state":50,"zip":50,"country":84,"countryCode":85,"cosmosGeoPoint":186,"geoPoint":190,"contacts":191},"Lasarettet i Ystad","Ystad",{"type":87,"coordinates":187},[188,189],13.82041,55.42966,{"lat":189,"lon":188},[192],{"name":182,"role":73,"phone":50,"phoneExt":50,"email":50},{"type":194,"investigatorFullName":50,"investigatorTitle":50,"investigatorAffiliation":50,"oldNameTitle":50,"oldOrganization":50},"SPONSOR","100564368",false,"NCT06628271","Breath-holding Spells and Its Management Study","Breath-holding Spells and Its Management: a Prospective Study on Patient and Disease Characteristics, Evaluation of Novel Guidelines, Parental Handling, and Long-term Follow-up in Breath-holding Spells","BAM","Inclusion Criteria:\n\n* Below 5 years of age\n* resident in Region Skåne (Sweden)\n* suspected breath-holding spell\n\nExclusion Criteria:\n\n* previous investigation for breath-holding spell (previous spells are not a reason for exclusion)","ALL","0 Months","60 Months",{"count":206,"type":207},120,"ESTIMATED","INTERVENTIONAL",[210],"NA","The goal of this prospective population-based study is to evaluate the new disease description and management guidelines for breath-holding spells in children (Hellström Schmidt et al, Acta Paediatrica 2024) below the age of 5 years in southern Sweden. The main questions it aims to answer are:\n\n* Does the disease description and management guidelines lead to the expected reduction in diagnostic interventions and are the clinical managements guidelines safe to use?\n* If iron supplementation is given, does it reduce the frequency and severity of the spells?\n* What information and support does parents to children with breath-holding spells need?\n\nParticipants will undergo evaluation by a medical doctor and if typical breath-holding spells are diagnosed, be managed according to the new guidelines. If iron deficiency is found, iron supplementation is recommended. Digital surveys will be distributed and parents of patients with frequent spells will be eligible for participation in an interview sub-study.",[213],"Breath-holding Spell",[215,216,217,218,219],"disease definition","electrocardiography","iron deficiency anemia","long QT syndrome","parental support","2026-05-04",{"date":222,"type":223},"2026-05-05","ACTUAL",{"date":225,"type":223},"2024-12-02",{"date":227,"type":207},"2030-12",{"name":5,"class":6},12]