NCT06628271

Breath-holding Spells and Its Management Study

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Region Skane · Academic / Other
• Sex: All
• Age: 0 Months – 60 Months
• Healthy volunteers: Not accepted

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.

Detailed description

Please see the Study plan among the documents.

Conditions

• Breath-holding Spell

Interventions

Type	Name	Description
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

Timeline

• Start date: 2024-12-02
• Primary completion: 2030-12-01
• Completion: 2030-12-01
• First posted: 2024-10-04
• Last updated: 2025-02-10

Locations

12 sites across 1 country: Sweden