An observational study in Sleep Apnea Syndromes in Children, Obesity in Children and Bronchopulmonary Dysplasia (BPD), sponsored by University Hospital, Grenoble. Not yet recruiting at 2 sites in France. Open to participants aged 0 Years to 17 Years. Per ClinicalTrials.gov, last updated 2024-11-18.
Sponsored by University Hospital, Grenoble · Observational
the primary outcome is to describe the perceived success of the use of the respiratory support from the parent's point of view
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.
1,129 studies on the registry are indexed under Pediatric Obesity; 187 are open to participants now.
This study's planned enrollment of 30 is below the median of 180 across 235 observational studies indexed under Pediatric Obesity.
Browse Pediatric Obesity studies →University Hospital, Grenoble is the lead sponsor of 837 studies on the registry; 207 are open to participants now.
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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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
describe the perceived success of the use of the respiratory support from the parent's point of view
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."
Time frame: Assessment during the filling of the questionnaire at enrollment
Describe the persistence of symptoms under ventilatory support according to the parent.
Answer to the question from the parent interview guide: "What symptoms did your child have before starting treatment? Have these symptoms improved?"
Time frame: Assessment during the filling of the questionnaire at enrollment
Describe the persistence of symptoms under ventilatory support according to the child
Answer to the question from the child interview guide: "Were you bothered before getting the machine? Is it better with the machine?"
Time frame: Assessment during the filling of the questionnaire at enrollment
Describe the tolerance of ventilatory support according to the parent.
Answer to the question from the parent interview guide: "Have you noticed any complications since your child started using the machine?"
Time frame: Assessment during the filling of the questionnaire at enrollment
Describe the tolerance of ventilatory support according to the child.
Answer to the question from the child interview guide: "Does the machine bother you?"
Time frame: Assessment during the filling of the questionnaire at enrollment
Describe adherence to ventilatory support according to the parent.
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?"
Time frame: Assessment during the filling of the questionnaire at enrollment
Describe adherence to ventilatory support according to the child.
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? "
Time frame: Assessment during the filling of the questionnaire at enrollment
This study is not yet recruiting, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
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