Home Ventilatory Support in Children

December 14, 2023 updated by: Tampere University Hospital
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).

Study Overview

Status

Active, not recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

94

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Ilmajoki, Finland, 60720
        • Mervi Järvelä

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

93 patients treated by a multidisciplinary paediatric home ventilatory support -team from January 2010 to December 2020 in Tampere University Hospital. The individuals were identified combining two sources: the team´s clinical list of patients and a database search from patient records with ICD-10 diagnose G47.3 (Sleep Apnea) in Pediatric Patient records.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Time Frame: 2022-2023
Data included patient demographics
2022-2023
Number of patients with clinical characteristics
Time Frame: 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.
2022-2023

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The duration of treatment
Time Frame: 2022-2023
The duration of treatment during January 2010 to December 2020 in Tampere University Hospital, Finland were collected.
2022-2023

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tampere University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2020

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

August 8, 2022

First Submitted That Met QC Criteria

December 14, 2023

First Posted (Estimated)

December 15, 2023

Study Record Updates

Last Update Posted (Estimated)

December 15, 2023

Last Update Submitted That Met QC Criteria

December 14, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R210861

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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