Clinical trial NCT04135430: Parental Assessment of the Quality of Life of Infants With Bronchiolitis Episodes
Official title: Parental Assessment of the Quality of Life of Infants Under 12 Months of Age With Moderate Bronchiolitis Referred for Ambulatory Respiratory Physiotherapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bronchiolitis
Keywords: Bronchiolitis
Infants
Chest physiotherapy
Lead sponsor: Association des Réseaux Bronchiolite
Sponsor class: UNKNOWN
First posted: 2019-10-22
Enrollment: 192
Sex: ALL
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Infants up to 12 months of age with first or second episode bronchiolitis

Brief summary: Infant bronchiolitis is a frequent pathology that is the cause of a very large number of medical outpatient and physiotherapy treatments in France. Many international studies and recommendations have invalidated any drug treatment during its management during the first episode. In France, the consensus conference promoted by the National Agency for Accreditation and Health Evaluation (ANAES) in September 2000 was in the same vein.

Regarding the respiratory physiotherapy component, posture drainage, vibration and percussion are not considered effective. ANAES recommended the use of respiratory physiotherapy with passive exhalation techniques. This is a method of care that has developed mainly in French-speaking countries, making it difficult to compare with the habits of Anglo-Saxon countries, which, more generally, do not prescribe it. In France, the level of evidence of its effectiveness is considered low (grade C). To date, the vast majority of studies have focused exclusively on a population of infants hospitalized for severe bronchiolitis. For this type of population, the value of such treatment to shorten the healing time has not been demonstrated. So much so that the ANAES, in its time, recommended that studies be carried out "on an outpatient basis" to assess their degree. In this respect, several recent studies have provided new data. Despite the reservations inherent in their methodologies and/or staff, they raise the question of the interest of the respiratory physiotherapy on an outpatient basis. In terms of professional practice, the American recommendations state that clinicians should educate family members about evidence-based diagnosis, treatment and prevention in bronchiolitis. Finally, an opinion survey concludes that holders of parental authority are seeking information on bronchiolitis and that approximately 90% have read the brochure given out of the maternity ward explaining the modes of transmission, manifestations, care and hygiene measures in the event of bronchiolitis. Pending new French recommendations, it seems legitimate to evaluate the level of perception of the effect of pediatric respiratory physiotherapy with increase in expiratory flow (IEF) in urban practice on the respiratory comfort of infants directly with families confronted with this pathology.

Detailed description: Infant bronchiolitis is a frequent pathology that is the cause of a very large number of medical outpatient and physiotherapy treatments in France. Many international studies and recommendations have invalidated any drug treatment during its management during the first episode. In France, the consensus conference promoted by the National Agency for Accreditation and Health Evaluation (ANAES) in September 2000 was in the same vein.

Regarding the respiratory physiotherapy component, posture drainage, vibration and percussion are not considered effective. ANAES recommended the use of respiratory physiotherapy with passive exhalation techniques. This is a method of care that has developed mainly in French-speaking countries, making it difficult to compare with the habits of Anglo-Saxon countries, which, more generally, do not prescribe it. In France, the level of evidence of its effectiveness is considered low (grade C). To date, the vast majority of studies have focused exclusively on a population of infants hospitalized for severe bronchiolitis. For this type of population, the value of such treatment to shorten the healing time has not been demonstrated. So much so that the ANAES, in its time, recommended that studies be carried out "on an outpatient basis" to assess their degree. In this respect, several recent studies have provided new data. Despite the reservations inherent in their methodologies and/or staff, they raise the question of the interest of respiratory physiotherapy in ambulatory care. In terms of professional practice, the American recommendations state that clinicians should educate family members about evidence-based diagnosis, treatment and prevention in bronchiolitis. Finally, an opinion survey concludes that holders of parental authority are seeking information on bronchiolitis and that approximately 90% have read the brochure given out of the maternity ward explaining the modes of transmission, manifestations, care and hygiene measures in the event of bronchiolitis. Pending new French recommendations, it seems legitimate to evaluate the level of perception of the effect of pediatric respiratory physiotherapy with increase in expiratory flow (IEF) in urban practice on the respiratory comfort of infants directly with families confronted with this pathology.

Eligibility criteria: Inclusion Criteria:

* Infant up to 12 months of age
* Wang's score ≥ at 4 and \< 9
* With first or second episode of bronchiolitis with a medical prescription for respiratory physiotherapy in the city.
* Consultation for a first session, or second session of respiratory physiotherapy

Exclusion Criteria:

* History or atopic predisposition
* History(s) of prematurity (34 weeks of amenorrhea or less)
* History of bronchopulmonary dysplasia
* Underlying heart disease, severe chronic lung disease
* Contraindication to the use of Kinesitherapy: prolonged corticosteroid therapy (more than one month), rickets, osteogenesis imperfecta, thrombocytopenia, rib fracture
* Opposition of holders of parental authority

Primary outcomes:
measure: QUALIN score
timeFrame: 24 hours
Secondary outcomes:
measure: Questionnaire about accessibility of the care chain
timeFrame: 8 days
measure: Questionnaire about understanding of the information
timeFrame: 8 days
measure: Questionnaire about perceived professional competence.
timeFrame: 8 days
measure: Questionnaire about security of care
timeFrame: 8 days
measure: Questionnaire about child's respiratory comfort
timeFrame: 8 days
Other outcomes:
Locations:
city: Amiens
country: France
facility: Rb Picard
city: Annecy-le-Vieux
country: France
facility: RB 74
city: Arpajon
country: France
facility: GAB
city: Bordeaux
country: France
facility: Aquirespi
city: Fleury-les-Aubrais
country: France
facility: Rb Loiret
city: La Rochelle
country: France
facility: La Rochelle
city: Léguevin
country: France
facility: Occirespi
city: Malzéville
country: France
facility: Rb Grand Est
city: Marseille
country: France
facility: ARBAM
city: Paris
country: France
facility: CHU Robert-Debré
city: Seclin
country: France
facility: RB 59 62
Study officials:
References: