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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:
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.
Please see the Study plan among the documents.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Typical spells | Other | Patients with typical spells should be investigated according to our guidelines |
|
| Non-typical spells | No Intervention | Patients with non-typical spells will be investigated individually, as it is done today |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Guidelines | Diagnostic Test | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Usability of the guidelines | Assessed according to the following:
| From date of inclusion until last diagnostic intervention, expected to be within 2 weeks from inclusion. |
| Usability of the disease definition | Assessed according to the following:
| From the inclusion date until end of physicians assessment |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Description | Time Frame |
|---|---|---|
| Natural course of the spells through long term follow-up | Assessed according to the following parameters, through digital surveys:
|
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sanna Hellström Schmidt, MD | Contact | +4646177203 | sanna.hellstrom_schmidt@med.lu.se | |
| Cornelis J Pronk, MD, PhD | Contact | kees-jan.pronk@med.lu.se |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Barn- och ungdomsmedicinmottagning Eslöv | Recruiting | Eslöv | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37905418 | Background | Hellstrom Schmidt S, Smedenmark J, Jeremiasen I, Sigurdsson B, Eklund EA, Pronk CJ. Overuse of EEG and ECG in children with breath-holding spells and its implication for the management of the spells. Acta Paediatr. 2024 Feb;113(2):317-326. doi: 10.1111/apa.17020. Epub 2023 Oct 31. | |
| 27060698 | Background | Hellstrom Schmidt S, Tedgard U, Pronk CJ. Breath-holding spells occur disproportionately more often in children with transient erythroblastopenia. Acta Paediatr. 2016 Sep;105(9):1088-93. doi: 10.1111/apa.13428. Epub 2016 Apr 29. |
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Data will be share as far as the Swedish law (concerning patient confidentiality) and ethical considerations allows. Decisions will be made from case to case depending on what data are inquired for.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 2, 2024 | Oct 2, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 16, 2024 | Sep 16, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D018798 | Anemia, Iron-Deficiency |
| D008133 | Long QT Syndrome |
| ID | Term |
|---|---|
| D000747 | Anemia, Hypochromic |
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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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.
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|
| 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:
| From the date of inclusion until evaluation of iron treatment, most probably within 12 months from inclusion. |
| 36 months |
| Contact with health care during long term follow-up | Evaluation of the following questions:
Above questions are assessed in a digital survey: - Further contact with healthcare. Answer alternatives: (Yes, No, Don't know). If yes: (acute or planned) | 36 months |
| Burden of care | Will be assessed through a combined evaluation of the following variables:
| 36 months |
| 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). The questions are as follows:
| From inclusion to blood test results, within 2 weeks from initial visit |
| Capio Barnavårdscentral Kristianstad | Recruiting | Kristianstad | Sweden |
|
| Barnläkargruppen Sparta | Recruiting | Lund | Sweden |
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| Skåne University Hospital | Recruiting | Lund | Sweden |
|
| Barnläkargruppen Sparta | Recruiting | Malmö | Sweden |
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| BVC Bambino Hyllie | Recruiting | Malmö | Sweden |
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| BVC Bambino Lindängen | Recruiting | Malmö | Sweden |
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| BVC Bambino Mobilia | Recruiting | Malmö | Sweden |
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| Skåne University Hospital | Recruiting | Malmö | Sweden |
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| Barn- och ungdomsmedicinmottagning Simrishamn, Capio närsjukhus | Recruiting | Simrishamn | Sweden |
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| Familjecentralen Björken, BVC Sjöbo | Recruiting | Sjöbo | Sweden |
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| Lasarettet i Ystad | Recruiting | Ystad | Sweden |
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| D000090463 |
| Iron Deficiencies |
| D019189 | Iron Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D000075224 | Cardiac Conduction System Disease |
| D006330 | Heart Defects, Congenital |
| D018376 | Cardiovascular Abnormalities |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |