Alveolar Hypoventilation, Bronchopulmonary Dysplasia (BPD), Malformation, Neuromuscular Disease, Obesity in Children, Sleep Apnea Syndromes in Children, Storage Disease
Conditions
Keywords
respiratory suport, sleep apnea syndrome, CPAP, BiPAP, ventilation, alveolar hypoventilation, non invasive ventilation
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.
Interventions
None listed
Sponsors
University Hospital, Grenoble
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
0 Years to 17 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| describe the perceived success of the use of the respiratory support from the parent's point of view | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Describe the persistence of symptoms under ventilatory support according to the child | 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? |
| Describe the tolerance of ventilatory support according to the parent. | 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? |
| Describe the persistence of symptoms under ventilatory support according to the parent. | 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? |
| Describe adherence to ventilatory support according to the parent. | 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? |
| Describe adherence to ventilatory support according to the child. | 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? |
| Describe the tolerance of ventilatory support according to the child. | Assessment during the filling of the questionnaire at enrollment | Answer to the question from the child interview guide: Does the machine bother you? |
Countries
France
Contacts
Primary ContactJulie CASSIBBA, MD
Backup ContactCamille BERTIN, Intern
Outcome results
None listed