Breath-holding Spells and Its Management Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Guidelines.
- Who it may be relevant to
- Registry conditions: Breath-holding Spell. Basic parameters: 0 months — 60 months · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Sweden
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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.
Detailed description
Please see the Study plan among the documents.
Interventions
- 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
Primary outcome measures
- Safety of the guidelines [Time frame: From date of inclusion to end of follow up at 36 months]
- Usability of the guidelines [Time frame: From date of inclusion until last diagnostic intervention, expected to be within 2 weeks from inclusion.]
- Usability of the disease definition [Time frame: From the inclusion date until end of physicians assessment]
Secondary outcome measures (2)
- Need of information and support to parents [Time frame: 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 [Time frame: From the date of inclusion until evaluation of iron treatment, most probably within 12 months from inclusion.]
Eligibility criteria
Inclusion criteria
- Below 5 years of age
- resident in Region Skåne (Sweden)
- suspected breath-holding spell
Exclusion criteria
- previous investigation for breath-holding spell (previous spells are not a reason for exclusion)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
Sweden · 12 centers
- Barn- och ungdomsmedicinmottagning Eslöv — Eslöv
- Capio Barnavårdscentral Kristianstad — Kristianstad
- Barnläkargruppen Sparta — Lund
- Skåne University Hospital — Lund
- Barnläkargruppen Sparta — Malmö
- BVC Bambino Hyllie — Malmö
- BVC Bambino Lindängen — Malmö
- BVC Bambino Mobilia — Malmö
- … and 4 more centers
Publications
- 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. PMID 37905418
- 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. PMID 27060698
Identifiers
NCT: NCT06628271 · 2023-03363-01