Breath-holding Spells and Its Management Study (BAM)

Region Skane

Status: Enrolling

Conditions: Breath-holding Spell

Treatments: Diagnostic Test: Guidelines

Study type: Interventional

Funder types: Other

Identifiers

NCT06628271

2023-03363-01

Details and patient eligibility

About

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.

Full description

Please see the Study plan among the documents.

Enrollment: 120 estimated patients

Sex: All

Ages: Under 60 months old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

Typical spells

Other group

Description:

Patients with typical spells should be investigated according to our guidelines

Treatment:

Diagnostic Test: Guidelines

Non-typical spells

No Intervention group

Description:

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