Overview: Use of Respiratory Support At Home in Children

NCT06692660 | Not Yet Recruiting

• 1 other identifier: 2024-A01045-42
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 2

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

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

Outcome Measures

Primary Outcomes (1)

• 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."

  Assessment during the filling of the questionnaire at enrollment

Secondary Outcomes (6)

• Describe the persistence of symptoms under ventilatory support according to the parent.

  Assessment during the filling of the questionnaire at enrollment

• Describe the persistence of symptoms under ventilatory support according to the child

  Assessment during the filling of the questionnaire at enrollment

• Describe the tolerance of ventilatory support according to the parent.

  Assessment during the filling of the questionnaire at enrollment

• Describe the tolerance of ventilatory support according to the child.

  Assessment during the filling of the questionnaire at enrollment

• Describe adherence to ventilatory support according to the parent.

  Assessment during the filling of the questionnaire at enrollment

Eligibility Criteria

• Age: 0 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

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

You may not qualify if:

• Palliative care
• Invasive ventilation
• High flow oxygen therapy

Sponsors & Collaborators

• University Hospital, Grenoble: lead

Study Sites (2)

Centre Hospitalier Universitaire Grenoble Alpes

Grenoble, Isère, 38100, France

Location

Centre Hospitalier Grenoble Alpes

La Tronche, 38700, France

Location

Related Publications (9)

• Amaddeo A, Khirani S, Griffon L, Teng T, Lanzeray A, Fauroux B. Non-invasive Ventilation and CPAP Failure in Children and Indications for Invasive Ventilation. Front Pediatr. 2020 Oct 26;8:544921. doi: 10.3389/fped.2020.544921. eCollection 2020.

  PMID: 33194886 BACKGROUND

• MacLean JE, Fauroux B. Long-term non-invasive ventilation in children: Transition from hospital to home. Paediatr Respir Rev. 2023 Sep;47:3-10. doi: 10.1016/j.prrv.2023.01.002. Epub 2023 Jan 12.

  PMID: 36806331 BACKGROUND

• Ramirez A, Delord V, Khirani S, Leroux K, Cassier S, Kadlub N, Aubertin G, Picard A, Fauroux B. Interfaces for long-term noninvasive positive pressure ventilation in children. Intensive Care Med. 2012 Apr;38(4):655-62. doi: 10.1007/s00134-012-2516-1. Epub 2012 Mar 6.

  PMID: 22392032 BACKGROUND

• McLaren AT, Bin-Hasan S, Narang I. Diagnosis, management and pathophysiology of central sleep apnea in children. Paediatr Respir Rev. 2019 Apr;30:49-57. doi: 10.1016/j.prrv.2018.07.005. Epub 2018 Jul 25.

  PMID: 30170958 BACKGROUND

• Marcus CL, Brooks LJ, Draper KA, Gozal D, Halbower AC, Jones J, Schechter MS, Sheldon SH, Spruyt K, Ward SD, Lehmann C, Shiffman RN; American Academy of Pediatrics. Diagnosis and management of childhood obstructive sleep apnea syndrome. Pediatrics. 2012 Sep;130(3):576-84. doi: 10.1542/peds.2012-1671. Epub 2012 Aug 27.

  PMID: 22926173 BACKGROUND

• Ramirez A, Khirani S, Aloui S, Delord V, Borel JC, Pepin JL, Fauroux B. Continuous positive airway pressure and noninvasive ventilation adherence in children. Sleep Med. 2013 Dec;14(12):1290-4. doi: 10.1016/j.sleep.2013.06.020. Epub 2013 Sep 25.

  PMID: 24157098 BACKGROUND

• Bhattacharjee R, Benjafield AV, Armitstead J, Cistulli PA, Nunez CM, Pepin JD, Woehrle H, Yan Y, Malhotra A; medXcloud group. Adherence in children using positive airway pressure therapy: a big-data analysis. Lancet Digit Health. 2020 Feb;2(2):e94-e101. doi: 10.1016/S2589-7500(19)30214-6. Epub 2019 Dec 23.

  PMID: 33334566 BACKGROUND

• Amaddeo A, Frapin A, Fauroux B. Long-term non-invasive ventilation in children. Lancet Respir Med. 2016 Dec;4(12):999-1008. doi: 10.1016/S2213-2600(16)30151-5. Epub 2016 Jul 13.

  PMID: 27423917 BACKGROUND

• Fauroux B, Abel F, Amaddeo A, Bignamini E, Chan E, Corel L, Cutrera R, Ersu R, Installe S, Khirani S, Krivec U, Narayan O, MacLean J, Perez De Sa V, Pons-Odena M, Stehling F, Ferreira RT, Verhulst S. ERS statement on paediatric long-term noninvasive respiratory support. Eur Respir J. 2022 Jun 2;59(6):2101404. doi: 10.1183/13993003.01404-2021. Print 2022 Jun.

  PMID: 34916265 BACKGROUND

MeSH Terms

Conditions

Pediatric Obesity; Bronchopulmonary Dysplasia; Neuromuscular Diseases; Congenital Abnormalities; Hypoventilation; Sleep Apnea Syndromes; Respiratory Aspiration

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Ventilator-Induced Lung Injury; Lung Injury; Lung Diseases; Respiratory Tract Diseases; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Nervous System Diseases; Respiratory Insufficiency; Respiration Disorders; Signs and Symptoms, Respiratory; Apnea; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Pathologic Processes

Central Study Contacts

Julie CASSIBBA, MD

CONTACT

+33476765566; jcassibba@chu-grenoble.fr

Camille BERTIN, Intern

CONTACT

+33660676532; cbertin1@chu-grenoble.fr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2024
• First Posted: November 18, 2024
• Study Start: November 1, 2024
• Primary Completion: August 1, 2025
• Study Completion: August 1, 2025
• Last Updated: November 18, 2024

Record last verified: 2024-11

Locations

FR (2)