Clinical trial NCT06628271: Breath-holding Spells and Its Management 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breath-holding Spell
Keywords: disease definition
electrocardiography
iron deficiency anemia
long QT syndrome
parental support
Lead sponsor: Region Skane
Sponsor class: OTHER
First posted: 2024-10-04
Enrollment: 120
Sex: ALL
Minimum age (years): 0
Maximum age (years): 60
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: DIAGNOSTIC

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.

Detailed description: Please see the Study plan among the documents.

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)

Primary outcomes:
measure: Safety of the guidelines
timeFrame: From date of inclusion to end of follow up at 36 months
measure: Usability of the guidelines
timeFrame: From date of inclusion until last diagnostic intervention, expected to be within 2 weeks from inclusion.
measure: Usability of the disease definition
timeFrame: From the inclusion date until end of physicians assessment
Secondary outcomes:
measure: Need of information and support to parents
timeFrame: From 6 months after inclusion until interview is performed (expected to be within three months of six month digital survey)
measure: Effect of iron supplement treatment on spell frequency and severity
timeFrame: From the date of inclusion until evaluation of iron treatment, most probably within 12 months from inclusion.
Other outcomes:
measure: Natural course of the spells through long term follow-up
timeFrame: 36 months
measure: Contact with health care during long term follow-up
timeFrame: 36 months
measure: Burden of care
timeFrame: 36 months
measure: Dietary impact on iron status
timeFrame: From inclusion to blood test results, within 2 weeks from initial visit
Locations:
city: Eslöv
country: Sweden
facility: Barn- och ungdomsmedicinmottagning Eslöv
city: Kristianstad
country: Sweden
facility: Capio Barnavårdscentral Kristianstad
city: Lund
country: Sweden
facility: Barnläkargruppen Sparta
city: Lund
country: Sweden
facility: Skåne University Hospital
city: Malmö
country: Sweden
facility: Barnläkargruppen Sparta
city: Malmö
country: Sweden
facility: BVC Bambino Hyllie
city: Malmö
country: Sweden
facility: BVC Bambino Lindängen
city: Malmö
country: Sweden
facility: BVC Bambino Mobilia
city: Malmö
country: Sweden
facility: Skåne University Hospital
city: Simrishamn
country: Sweden
facility: Barn- och ungdomsmedicinmottagning Simrishamn, Capio närsjukhus
city: Sjöbo
country: Sweden
facility: Familjecentralen Björken, BVC Sjöbo
city: Ystad
country: Sweden
facility: Lasarettet i Ystad
Study officials:
References:
citation: 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.
citation: 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.