Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06628271
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-16
Brief Title:
Breath-holding Spells and Its Management Study
Sponsor:
None
Organization:
None
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BAM
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None