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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Region Skane
- 入组人数
- 120
- 试验地点
- 12
- 主要终点
- Safety of the guidelines
研究概览
简要总结
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:
- Does the disease description and management guidelines lead to the expected reduction in diagnostic interventions and are the clinical managements guidelines safe to use?
- If iron supplementation is given, does it reduce the frequency and severity of the spells?
- What information and support does parents to children with breath-holding spells need?
Participants 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.
详细描述
Please see the Study plan among the documents.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 0 Months 至 60 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Below 5 years of age
- •resident in Region Skåne (Sweden)
- •suspected breath-holding spell
排除标准
- •previous investigation for breath-holding spell (previous spells are not a reason for exclusion)
结局指标
主要结局
Safety of the guidelines
时间窗: From date of inclusion to end of follow up at 36 months
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).
Usability of the guidelines
时间窗: From date of inclusion until last diagnostic intervention, expected to be within 2 weeks from inclusion.
Assessed according to the following: * Number of patients with a diagnostic interventions for each intervention in the guidelines: ECGs and bloodtests. * 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). * 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).
Usability of the disease definition
时间窗: From the inclusion date until end of physicians assessment
Assessed according to the following: * 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. * The number of typical spells compared to the number of non-typical spells and other diagnsoses. * Compilation of patient and spell characteristics (defined in the variable list in the attached documents) and comparison with the current definition of typical spells.
次要结局
- Need of information and support to parents(From 6 months after inclusion until interview is performed (expected to be within three months of six month digital survey))
- Effect of iron supplement treatment on spell frequency and severity(From the date of inclusion until evaluation of iron treatment, most probably within 12 months from inclusion.)