Overview: Use of Respiratory Support At Home in Children (ELIPSE)

November 14, 2024 updated by: University Hospital, Grenoble

An Overview of the Use of Respiratory Support At Home in Children - Patients and Families Point of View

the primary outcome is to describe the perceived success of the use of the respiratory support from the parent's point of view

Study Overview

Status

Not yet recruiting

Conditions

Detailed Description

The use of ventilatory support, including CPAP (Continuous Positive Airway Pressure), which is a mode of ventilation with continuous positive pressure, and BiPAP (Bilevel Positive Airway Pressure), which is a mode of ventilation with two levels of pressure, has seen a significant increase in indications in recent years. The indications have become more numerous and increasingly complex. Sleep-related respiratory disorders, including obstructive sleep apnea-hypopnea syndrome, central apnea syndrome, and alveolar hypoventilation, are the primary reasons for these indications. In pediatrics, numerous conditions contribute to sleep-related respiratory disorders: ENT malformations, genetic conditions, obesity, bronchopulmonary dysplasia, neuromuscular diseases, thoracic deformities, and storage diseases.

The non-use or insufficient use of ventilatory support leads to a lack of treatment for sleep-related respiratory disorders. In the absence of treatment, the consequences are neurocognitive, cardiovascular, and metabolic, resulting in high morbidity. Non-use or insufficient use is a cause of failure of ventilatory support. Neither the use nor the failure of ventilatory support is clearly defined. It is crucial to evaluate the use of ventilatory support in order to correct factors related to non-use or insufficient use and to prevent the negative consequences resulting from unaddressed sleep-related respiratory disorders. This pilot study aims to assess the use of ventilatory support at home in pediatrics through interviews with patients and their parents. We will use a questionnaire designed for the study, consisting of 10 questions regarding sleep, symptoms, quality of life, technical issues, side effects, economic barriers, and adherence, to describe their experiences with ventilatory support.

Study Type

Observational

Enrollment (Estimated)

30

Contacts and Locations

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

Study Contact

Study Contact Backup

Study Locations

  • France
      • La Tronche, France, 38700
        • Centre Hospitalier Grenoble Alpes
        • Contact:
        • Contact:
        • Contact:
          • Julie CASSIBBA, MD
    • Isère
      • Grenoble, Isère, France, 38100
        • Centre Hospitalier Universitaire Grenoble Alpes

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

No

Sampling Method

Probability Sample

Study Population

Our study population includes patients from the Grenoble Alpes Hospital, from 0 to 18 (not yet passed) years old. These patients benefit from respiratory support at home. Their follow-up is done at the Grenoble Alpes Hospital. We will not include patients who benefit from palliative care, invasive ventilation or high flow oxygen therapy.

Description

Inclusion Criteria:

  • Children with respiratory support at home
  • Age 0 to 18 (not yet passed) years old

Exclusion Criteria:

  • Palliative care
  • Invasive ventilation
  • High flow oxygen therapy

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
describe the perceived success of the use of the respiratory support from the parent's point of view
Time Frame: Assessment during the filling of the questionnaire at enrollment
The primary outcome measure is the median score and interquartile range, obtained from the answer modalities according to the Likert scale (scores ranging from 1 to 5), in response to the question from the parent interview guide, which states: "Do you consider that the ventilatory support proposed for your child is a success? Please circle the corresponding score."
Assessment during the filling of the questionnaire at enrollment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Describe the persistence of symptoms under ventilatory support according to the parent.
Time Frame: Assessment during the filling of the questionnaire at enrollment
Answer to the question from the parent interview guide: "What symptoms did your child have before starting treatment? Have these symptoms improved?"
Assessment during the filling of the questionnaire at enrollment
Describe the persistence of symptoms under ventilatory support according to the child
Time Frame: Assessment during the filling of the questionnaire at enrollment
Answer to the question from the child interview guide: "Were you bothered before getting the machine? Is it better with the machine?"
Assessment during the filling of the questionnaire at enrollment
Describe the tolerance of ventilatory support according to the parent.
Time Frame: Assessment during the filling of the questionnaire at enrollment
Answer to the question from the parent interview guide: "Have you noticed any complications since your child started using the machine?"
Assessment during the filling of the questionnaire at enrollment
Describe the tolerance of ventilatory support according to the child.
Time Frame: Assessment during the filling of the questionnaire at enrollment
Answer to the question from the child interview guide: "Does the machine bother you?"
Assessment during the filling of the questionnaire at enrollment
Describe adherence to ventilatory support according to the parent.
Time Frame: Assessment during the filling of the questionnaire at enrollment
Answer to the question from the parent interview guide: "How many hours does your child use the machine at night? How many nights per week? Does your child use the machine when you go away for the weekend or on vacation...? If not, why?" For children aged 0-4 years: "Does the child wear it during naps? How many naps per week?"
Assessment during the filling of the questionnaire at enrollment
Describe adherence to ventilatory support according to the child.
Time Frame: Assessment during the filling of the questionnaire at enrollment
Answer to the question from the child interview guide: "Can you wear your machine all night? Every night? Do you wear your machine when you're not sleeping at home? If not, why? "
Assessment during the filling of the questionnaire at enrollment

Collaborators and Investigators

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

Sponsor

University Hospital, Grenoble

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Estimated)

November 1, 2024

Primary Completion (Estimated)

August 1, 2025

Study Completion (Estimated)

August 1, 2025

Study Registration Dates

First Submitted

November 14, 2024

First Submitted That Met QC Criteria

November 14, 2024

First Posted (Estimated)

November 18, 2024

Study Record Updates

Last Update Posted (Estimated)

November 18, 2024

Last Update Submitted That Met QC Criteria

November 14, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-A01045-42

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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