Home Ventilatory Support in Children

Sleep Apnea Syndromes in Children Clinical Trial

Official title:

Home Ventilatory Support in Children

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06172868
• Other study ID #: R210861
• Status: Active, not recruiting
• Start date: October 1, 2020
• Est. completion date: December 1, 2027

Study information

• Verified date: December 2023
• Source: Tampere University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The study consist of children, who have used home ventilatory support during years 2010-2020 in Tampere University Hospital. The study will describe retrospectively different diagnoses and symptoms which will lead to home ventilatory support. We also study compliance to treatment and it's disanvantages. The prospective part of the study describes the quality of live of these children by using questionnaires (PedSQL).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 94
• Est. completion date: December 1, 2027
• Est. primary completion date: December 2026
• Gender: All
• Age group: N/A to 16 Years

Eligibility

Inclusion Criteria:

• ICD-10 Code for Sleep apnea diagnose G47.3 AND G47.3 diagnose found from pediatric electronic patient records between years 2010-2020 OR Patient name found from pediatric multidisciplinary home respiratory team's clinical list

Exclusion Criteria:

• Age over 16
• Patient starting home ventilation after 31st December 2020 or treatment ending before 1st January 2010
• patients with sleep apnea but without home respiratory support treatment
• Only theophylline treatment
• High-flow oxygen therapy
• Age over 16 at treatment onset
• Never started treatment
• Treatment starting point and ending before year 2010

Related Conditions & MeSH terms

• Sleep Apnea Syndromes
• Sleep Apnea Syndromes in Children

Locations

Country	Name	City	State
Finland	Mervi Järvelä	Ilmajoki

Sponsors (1)

Lead Sponsor	Collaborator
Tampere University Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient demographics of patients from 0 up to 16 years old treated by a multidisciplinary home respiratory support-team during January 2010 to December 2020 in Tampere University Hospital, Finland	Data included patient demographics	2022-2023
Primary	Number of patients with clinical characteristics	Data included underlying medical conditions and medications. The circumstances for home respiratory support onset, frequency of follow-up, complications, operative interventions to treat sleep apnea before and during period with home respiratory support were collected. The type of respiratory support (device, mode, interface) was recorded.	2022-2023
Secondary	The duration of treatment	The duration of treatment during January 2010 to December 2020 in Tampere University Hospital, Finland were collected.	2022-2023