Parental Assessment of the Quality of Life of Infants With Bronchiolitis Episodes
BRONKILIB3
2 other identifiers
observational
192
1 country
11
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Oct 2019
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 30, 2019
CompletedStudy Start
First participant enrolled
October 14, 2019
CompletedFirst Posted
Study publicly available on registry
October 22, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 27, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
April 4, 2021
CompletedJune 8, 2021
June 1, 2021
1.5 years
September 30, 2019
June 7, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
QUALIN score
Evolution of the Quality of life of infants and young children (QUALIN) score between before the session and 12 to 24 hours after the session.
24 hours
Secondary Outcomes (5)
Questionnaire about accessibility of the care chain
8 days
Questionnaire about understanding of the information
8 days
Questionnaire about perceived professional competence.
8 days
Questionnaire about security of care
8 days
Questionnaire about child's respiratory comfort
8 days
Study Arms (1)
Survey
Practice of an updated questionnaire at D0, D2 and D7
Interventions
Eligibility Criteria
Infants up to 12 months of age with first or second episode bronchiolitis
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (11)
Rb Picard
Amiens, France
RB 74
Annecy-le-Vieux, France
GAB
Arpajon, France
Aquirespi
Bordeaux, France
Rb Loiret
Fleury-les-Aubrais, France
La Rochelle
La Rochelle, France
Occirespi
Léguevin, France
Rb Grand Est
Malzéville, France
ARBAM
Marseille, France
CHU Robert-Debré
Paris, France
RB 59 62
Seclin, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- UNKNOWN
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 30, 2019
First Posted
October 22, 2019
Study Start
October 14, 2019
Primary Completion
March 27, 2021
Study Completion
April 4, 2021
Last Updated
June 8, 2021
Record last verified: 2021-06
Data Sharing
- IPD Sharing
- Will not share