NCT06628271 Breath-holding Spells and Its Management Study
| NCT ID | NCT06628271 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Region Skane |
| Condition | Breath-holding Spell |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2024-12-02 |
| Primary Completion | 2030-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 120 participants in total. It began in 2024-12-02 with a primary completion date of 2030-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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)
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06628271 clinical trial?
This trial is open to participants of all sexes, aged 0 Months or older, up to 60 Months, studying Breath-holding Spell. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06628271 currently recruiting?
Yes, NCT06628271 is actively recruiting participants. Contact the research team at sanna.hellstrom_schmidt@med.lu.se for enrollment information.
Where is the NCT06628271 trial being conducted?
This trial is being conducted at Eslöv, Sweden, Kristianstad, Sweden, Lund, Sweden, Lund, Sweden and 8 additional locations.
Who is sponsoring the NCT06628271 clinical trial?
NCT06628271 is sponsored by Region Skane. The trial plans to enroll 120 participants.