Home Ventilatory Support in Children

Active, not recruiting

• Conditions: Sleep Apnea Syndromes in Children

• Registration Number: NCT06172868
• Lead Sponsor: Tampere University Hospital

Brief 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2020-10-01
• Study First Submitted: 2022-08-08
• Status Verified: 2023-12
• Study First Submitted QC: 2023-12-14
• Last Update Submitted: 2023-12-14
• Study First Posted: 2023-12-15
• Last Update Posted: 2023-12-15
• Primary Completion: 2026-12
• Study Completion: 2027-12-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 94

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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	2022-2023	Data included patient demographics
Number of patients with clinical characteristics	2022-2023	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.

Secondary Outcome Measures

Name	Time	Method
The duration of treatment	2022-2023	The duration of treatment during January 2010 to December 2020 in Tampere University Hospital, Finland were collected.

Trial Locations

Locations (1)

Mervi Järvelä; 🇫🇮 Ilmajoki, Finland