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NCT Number: NCT06692660

Overview: Use of Respiratory Support At Home in Children

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

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Key information

Conditions

Sleep Apnea Syndromes in Children Alveolar Hypoventilation Apnea Body Weight Bronchopulmonary Dysplasia Bronchopulmonary Dysplasia (BPD) Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dyssomnias Hypoventilation Infant, Newborn, Diseases Infant, Premature, Diseases Lung Diseases Lung Injury Malformation Nervous System Diseases Neuromuscular Disease Neuromuscular Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Obesity in Children Overnutrition Overweight Pathologic Processes Pathological Conditions, Signs and Symptoms Pediatric Obesity Respiration Disorders Respiratory Aspiration Respiratory Insufficiency Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory Sleep Apnea Syndromes Sleep Disorders, Intrinsic Sleep Wake Disorders Storage Disease Ventilator-Induced Lung Injury

Age range

0 year–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre Hospitalier Universitaire Grenoble Alpes, Grenoble, Isère, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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."

Secondary outcomes

  1. 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?"

  2. 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?"

  3. 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?"

  4. 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?"

  5. 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?"

  6. 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? "

Study contacts

Contact information is provided by the study sponsor or research team.

Camille BERTIN, Intern

CONTACT

[email protected]

+33660676532

Julie CASSIBBA, MD

CONTACT

[email protected]

+33476765566

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Registry information

Official study title

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

Acronym: ELIPSE

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 18, 2024
Registry last updated
Nov 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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