Clinical trial NCT06692660: Overview: Use of Respiratory Support At Home in Children
Official title: An Overview of the Use of Respiratory Support At Home in Children - Patients and Families Point of View
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Sleep Apnea Syndromes in Children
Obesity in Children
Bronchopulmonary Dysplasia (BPD)
Neuromuscular Disease
Storage Disease
Malformation
Alveolar Hypoventilation
Keywords: respiratory suport
sleep apnea syndrome
CPAP
BiPAP
ventilation
alveolar hypoventilation
non invasive ventilation
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2024-11-18
Enrollment: 30
Sex: ALL
Minimum age (years): 0
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: describe the perceived success of the use of the respiratory support from the parent's point of view
timeFrame: Assessment during the filling of the questionnaire at enrollment
Secondary outcomes:
measure: Describe the persistence of symptoms under ventilatory support according to the parent.
timeFrame: Assessment during the filling of the questionnaire at enrollment
measure: Describe the persistence of symptoms under ventilatory support according to the child
timeFrame: Assessment during the filling of the questionnaire at enrollment
measure: Describe the tolerance of ventilatory support according to the parent.
timeFrame: Assessment during the filling of the questionnaire at enrollment
measure: Describe the tolerance of ventilatory support according to the child.
timeFrame: Assessment during the filling of the questionnaire at enrollment
measure: Describe adherence to ventilatory support according to the parent.
timeFrame: Assessment during the filling of the questionnaire at enrollment
measure: Describe adherence to ventilatory support according to the child.
timeFrame: Assessment during the filling of the questionnaire at enrollment
Other outcomes:
Locations:
city: Grenoble
country: France
facility: Centre Hospitalier Universitaire Grenoble Alpes
state: Isère
city: La Tronche
country: France
facility: Centre Hospitalier Grenoble Alpes
Study officials:
References:
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