Breath-holding SpellBAMNCT06628271
Breath-holding Spells and Its Management Study
A study testing Guidelines in people with Breath-holding Spell, run by Region Skane at 12 sites in Sweden.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 0 to 60 months
- Conditions the study is for
- Breath-holding Spell
- What is being tested?
- Guidelines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 12 sitesSweden
- Study dates
- 2 Dec 2024to Dec 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 60 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Below 5 years of age
- resident in Region Skåne (Sweden)
- suspected breath-holding spell
Who cannot join
- previous investigation for breath-holding spell (previous spells are not a reason for exclusion)
Trial locations and contacts
12 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Cornelis J Pronk, MD, PhD contact
12 sites in 1 country
Sweden12 sites, 12 recruiting
- Recruiting
Barn- och ungdomsmedicinmottagning Eslöv
Eslöv
Annika Lagström
- Recruiting
Capio Barnavårdscentral Kristianstad
Kristianstad
Linda Nyberg
- Recruiting
Barnläkargruppen Sparta
Lund
Johanna Bengtsson
- Recruiting
Skåne University Hospital
Lund
Sanna Hellström Schmidt, MD
- Recruiting
Barnläkargruppen Sparta
Malmö
Johanna Bengtsson
- Recruiting
BVC Bambino Hyllie
Malmö
Anna Sövgren
- Recruiting
BVC Bambino Lindängen
Malmö
Anna Sövgren
- Recruiting
BVC Bambino Mobilia
Malmö
Anna Sövgren
- Recruiting
Skåne University Hospital
Malmö
Sanna Hellström Schmidt, MD
- Recruiting
Barn- och ungdomsmedicinmottagning Simrishamn, Capio närsjukhus
Simrishamn
Therése Saksø
- Recruiting
Familjecentralen Björken, BVC Sjöbo
Sjöbo
Gustav Robertz, MD
- Recruiting
Lasarettet i Ystad
Ystad
Gustav Robertz, MD
About this study
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
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.
Read the detailed description
Please see the Study plan among the documents.
- Conditions
- Breath-holding Spell
- Being tested
- Guidelines
- Keywords
- disease definition, electrocardiography, iron deficiency anemia, long QT syndrome, parental support
- Medical subject headings
- Anemia, Iron-Deficiency, Long QT Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GuidelinesDiagnostic 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
| Study group | Role | What they receive |
|---|---|---|
| Typical spells | Other | Patients with typical spells should be investigated according to our guidelines Receives: Diagnostic Test: Guidelines |
| Non-typical spells | No intervention | Patients with non-typical spells will be investigated individually, as it is done today |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: From date of inclusion to end of follow up at 36 months
Usability of the guidelines
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).
Measured: 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:
- 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.
Measured: From the inclusion date until end of physicians assessment
Secondary outcomes (2)
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).
Measured: 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
In cases of iron treatment (initiated by the clinical physician). Assessed according to the following:
- Comparison of spell frequency (number of spells/time unit) before start of treatment, during treatment and after completion of treament.
- 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.
- 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.
- Patient compliance for iron supplementation as per survey question with answer altneratives yes/no/don't know
Measured: From the date of inclusion until evaluation of iron treatment, most probably within 12 months from inclusion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2024
- Study start2 Dec 2024
- Primary completionDec 2030 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Breath-holding SpellStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06628271
- Sponsor's protocol ID
- 2023-03363-01
- Other IDs
- 2023
- Acronym
- BAM
- Status last verified
- Apr 2026
- First submitted
- 16 Sep 2024
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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.
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.
PubMed 37905418Hellstrom 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.
PubMed 27060698
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06628271
- Acronym / sponsor ID
- BAM / 2023-03363-01
- Conditions
- Breath-holding Spell
- Keywords
- disease definition, electrocardiography, iron deficiency anemia, long QT syndrome, parental support
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Study start
- 2 Dec 2024 (actual)
- Primary completion
- Dec 2030 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 4 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Typical spells | Other | Diagnostic Test: GuidelinesPatients 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 |
Who may qualify
- Ages
- 0 to 60 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Below 5 years of age
- resident in Region Skåne (Sweden)
- suspected breath-holding spell
Key exclusion criteria (1 listed)
- previous investigation for breath-holding spell (previous spells are not a reason for exclusion)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GuidelinesParticipant 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 | Diagnostic test | Typical spells |
Primary outcome
Safety of the guidelines
Time frame: 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
Time frame: 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
Time frame: 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.
2 secondary outcomes
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- Background: PubMed 37905418Hellstrom 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.
- Background: PubMed 27060698Hellstrom 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.
- Individual participant dataSharing planned: Undecided. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Cornelis J Pronk, MD, PhD contact
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Guidelines in people with Breath-holding Spell, run by Region Skane at 12 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sanna Hellström Schmidt, MD (+4646177203, sanna.hellstrom_schmidt@med.lu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of the guidelines (time frame: From date of inclusion to end of follow up at 36 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06628271, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026.