Actively Recruiting

Phase Not Applicable
Age: 0Months - 60Months
All Genders
ID06628271

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

Led by Region Skane · Updated on 2026-05-05

120

Participants Needed

12

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating new disease descriptions and management guidelines for breath-holding spells in children under 5 years old in southern Sweden. The study aims to determine if these guidelines reduce unnecessary diagnostic procedures and are safe to use. It also investigates whether iron supplements decrease the frequency and severity of these spells and explores what information and support parents need for managing their children's condition. Children diagnosed with typical breath-holding spells will be managed according to the new guidelines, which include cardiac evaluations like ECG for those with relevant family history or symptoms, and blood tests for anemia and iron deficiency if the child has multiple spells. Children with non-typical spells will be assessed individually using current practices. If iron deficiency is identified, supplementation is recommended. Some parents of children with frequent spells may participate in interviews as part of a sub-study. Participants will be evaluated by medical doctors and monitored through digital surveys over time. Researchers will assess the safety and usability of the guidelines, the effectiveness of iron treatment, and the support needs of parents. The study includes follow-up for up to 36 months to monitor outcomes and uses interviews and surveys to gather detailed information from families. The total participation duration varies, with specific assessments scheduled within weeks to months after inclusion.

CONDITIONS

Brief Title

Breath-holding Spells and Its Management Study

Who Can Participate

Age: 0Months - 60Months
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Below 5 years of age
  • Resident in Region Skåne (Sweden)
  • Suspected breath-holding spell
Not Eligible

You will not qualify if you...

  • Previous investigation for breath-holding spell (previous spells are not a reason for exclusion)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Diagnostic Evaluation

Duration - Up to 2 weeks from inclusion

Participants with typical spells will be investigated according to the study guidelines, which may include an ECG and blood tests for anemia and iron deficiency based on symptoms and history. Participants with non-typical spells will be investigated individually as usual.

1 to 2 visits depending on investigations required

Long-term Monitoring

Duration - Up to 36 months from inclusion

Participants will be followed for safety and usability of the guidelines, with assessments including parental support needs and evaluation of iron treatment effects on spell frequency and severity.

Interviews and surveys conducted periodically during follow-up

Trial Site Locations

Total: 12 locations

1

Barn- och ungdomsmedicinmottagning Eslöv

Eslöv, Sweden

Actively Recruiting

2

Capio Barnavårdscentral Kristianstad

Kristianstad, Sweden

Actively Recruiting

3

Barnläkargruppen Sparta

Lund, Sweden

Actively Recruiting

4

Skåne University Hospital

Lund, Sweden

Actively Recruiting

5

Barnläkargruppen Sparta

Malmö, Sweden

Actively Recruiting

6

BVC Bambino Hyllie

Malmö, Sweden

Actively Recruiting

7

BVC Bambino Lindängen

Malmö, Sweden

Actively Recruiting

8

BVC Bambino Mobilia

Malmö, Sweden

Actively Recruiting

9

Skåne University Hospital

Malmö, Sweden

Actively Recruiting

10

Barn- och ungdomsmedicinmottagning Simrishamn, Capio närsjukhus

Simrishamn, Sweden

Actively Recruiting

11

Familjecentralen Björken, BVC Sjöbo

Sjöbo, Sweden

Actively Recruiting

12

Lasarettet i Ystad

Ystad, Sweden

Actively Recruiting

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Research Team

S

Sanna Hellström Schmidt, MD

C

Cornelis J Pronk, MD, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

DIAGNOSTIC

Number of Arms

2

Frequently Asked Questions

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Published Research Related To This Trial

Overuse of EEG and ECG in children with breath-holding spells and its implication for the management of the spells.

Sanna Hellström Schmidt, Julia Smedenmark, Ida Jeremiasen...

https://pubmed.ncbi.nlm.nih.gov/37905418

Breath-holding spells occur disproportionately more often in children with transient erythroblastopenia.

Sanna Hellström Schmidt, Ulf Tedgård, Cornelis J H Pronk

https://pubmed.ncbi.nlm.nih.gov/27060698