Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
120 participants
INTERVENTIONAL
2024-12-02
2030-12-31
Brief Summary
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* 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.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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Typical spells
Patients with typical spells should be investigated according to our guidelines
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
Non-typical spells
Patients with non-typical spells will be investigated individually, as it is done today
No interventions assigned to this group
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* resident in Region Skåne (Sweden)
* suspected breath-holding spell
Exclusion Criteria
0 Months
60 Months
ALL
No
Sponsors
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Region Skane
OTHER
Responsible Party
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Locations
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Barn- och ungdomsmedicinmottagning Eslöv
Eslöv, , Sweden
Capio Barnavårdscentral Kristianstad
Kristianstad, , Sweden
Barnläkargruppen Sparta
Lund, , Sweden
Skåne University Hospital
Lund, , Sweden
Barnläkargruppen Sparta
Malmo, , Sweden
BVC Bambino Hyllie
Malmo, , Sweden
BVC Bambino Lindängen
Malmo, , Sweden
BVC Bambino Mobilia
Malmo, , Sweden
Skåne University Hospital
Malmo, , Sweden
Barn- och ungdomsmedicinmottagning Simrishamn, Capio närsjukhus
Simrishamn, , Sweden
Familjecentralen Björken, BVC Sjöbo
Sjöbo, , Sweden
Lasarettet i Ystad
Ystad, , Sweden
Countries
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Central Contacts
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Facility Contacts
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Annika Lagström
Role: primary
Linda Nyberg
Role: primary
Johanna Bengtsson
Role: primary
Sanna Hellström Schmidt, MD
Role: primary
Johanna Bengtsson
Role: primary
Anna Sövgren
Role: primary
Anna Sövgren
Role: primary
Anna Sövgren
Role: primary
Sanna Hellström Schmidt, MD
Role: primary
Therése Saksø
Role: primary
Gustav Robertz, MD
Role: primary
Gustav Robertz, MD
Role: primary
References
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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.
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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2023-03363-01
Identifier Type: -
Identifier Source: org_study_id
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