Breath-holding Spells and Its Management Study

NCT06628271 | Recruiting

• 1 other identifier: 2023-03363-01
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 12

Brief 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. 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.

Conditions

Breath-holding Spell

Keywords

disease definition; electrocardiography; iron deficiency anemia; long QT syndrome; parental support

Outcome Measures

Primary Outcomes (3)

• 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: * 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).

  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.

  From the inclusion date until end of physicians assessment

Secondary Outcomes (2)

• 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.

Other Outcomes (4)

• Natural course of the spells through long term follow-up

  36 months

• Contact with health care during long term follow-up

  36 months

• Burden of care

  36 months

Study Arms (2)

Typical spells

OTHER

Patients with typical spells should be investigated according to our guidelines

Diagnostic Test: Guidelines

Non-typical spells

NO INTERVENTION

Patients with non-typical spells will be investigated individually, as it is done today

Interventions

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

Typical spells

Eligibility Criteria

• Age: 0 Months - 60 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Below 5 years of age
• resident in Region Skåne (Sweden)
• suspected breath-holding spell

Sponsors & Collaborators

• Region Skane: lead

Study Sites (12)

Barn- och ungdomsmedicinmottagning Eslöv

Eslöv, Sweden

RECRUITING

Capio Barnavårdscentral Kristianstad

Kristianstad, Sweden

RECRUITING

Barnläkargruppen Sparta

Lund, Sweden

RECRUITING

Skåne University Hospital

Lund, Sweden

RECRUITING

Barnläkargruppen Sparta

Malmö, Sweden

RECRUITING

BVC Bambino Hyllie

Malmö, Sweden

RECRUITING

BVC Bambino Lindängen

Malmö, Sweden

RECRUITING

BVC Bambino Mobilia

Malmö, Sweden

RECRUITING

Skåne University Hospital

Malmö, Sweden

RECRUITING

Barn- och ungdomsmedicinmottagning Simrishamn, Capio närsjukhus

Simrishamn, Sweden

RECRUITING

Familjecentralen Björken, BVC Sjöbo

Sjöbo, Sweden

RECRUITING

Lasarettet i Ystad

Ystad, Sweden

RECRUITING

Related Publications (2)

• 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 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.

  PMID: 27060698 BACKGROUND

MeSH Terms

Conditions

Anemia, Iron-Deficiency; Long QT Syndrome

Condition Hierarchy (Ancestors)

Anemia, Hypochromic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Deficiencies; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Heart Defects, Congenital; Cardiovascular Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Sanna Hellström Schmidt, MD

CONTACT

+4646177203; sanna.hellstrom_schmidt@med.lu.se

Cornelis J Pronk, MD, PhD

CONTACT

kees-jan.pronk@med.lu.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 16, 2024
• First Posted: October 4, 2024
• Study Start: December 2, 2024
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): December 1, 2030
• Last Updated: May 5, 2026

Record last verified: 2026-04

Locations

SE (12)