Parental Assessment of the Quality of Life of Infants With Bronchiolitis Episodes (BRONKILIB3)

Parental Assessment of the Quality of Life of Infants Under 12 Months of Age With Moderate Bronchiolitis Referred for Ambulatory Respiratory Physiotherapy

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.

Study Overview

• Status: Completed
• Conditions: Bronchiolitis
• Intervention / Treatment: Other: Survey

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.

• Study Type: Observational
• Enrollment (Actual): 192

Contacts and Locations

Study Locations

• France
  • Amiens, France
    • Rb Picard
  • Annecy-le-Vieux, France
    • RB 74
  • Arpajon, France
    • GAB
  • Bordeaux, France
    • Aquirespi
  • Fleury-les-Aubrais, France
    • Rb Loiret
  • La Rochelle, France
    • La Rochelle
  • Léguevin, France
    • Occirespi
  • Malzéville, France
    • Rb Grand Est
  • Marseille, France
    • ARBAM
  • Paris, France
    • CHU Robert-Debré
  • Seclin, France
    • RB 59 62

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 1 year (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Infants up to 12 months of age with first or second episode bronchiolitis

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Survey; Practice of an updated questionnaire at D0, D2 and D7	Other: Survey; practice of an updated questionnaire at D0, D2 and D7

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Questionnaire about accessibility of the care chain	This is a questionnaire that has not been validated in the literature. Its purpose is to assess the feelings of holders of parental authority about the conditions of access to outpatient care.	8 days
Questionnaire about understanding of the information	This is a questionnaire that has not been validated in the literature. The purpose of this questionnaire is to evaluate the parent's feelings about understanding information	8 days
Questionnaire about perceived professional competence.	This is a questionnaire that has not been validated in the literature. The purpose of this questionnaire is to evaluate the parent's feelings about perceived professional competence	8 days
Questionnaire about security of care	This is a questionnaire that has not been validated in the literature. The purpose of this questionnaire is to evaluate the parent's feelings about perceived professional competence The security of care	8 days
Questionnaire about child's respiratory comfort	This is a questionnaire that has not been validated in the literature. The purpose of this questionnaire is to evaluate the parent's feelings about the evolution of their child's respiratory comfort after the physiotherapy session.	8 days

Collaborators and Investigators

• Sponsor: Association des Réseaux Bronchiolite

Study record dates

Study Major Dates

• Study Start (Actual): October 14, 2019
• Primary Completion (Actual): March 27, 2021
• Study Completion (Actual): April 4, 2021

Study Registration Dates

• First Submitted: September 30, 2019
• First Submitted That Met QC Criteria: October 21, 2019
• First Posted (Actual): October 22, 2019

Study Record Updates

• Last Update Posted (Actual): June 8, 2021
• Last Update Submitted That Met QC Criteria: June 7, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: Infants; Bronchiolitis; Chest physiotherapy
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Bronchitis; Bronchiolitis
• Other Study ID Numbers: BRONKILIB3; 2019-A01633-54 (Other Identifier: ID-RCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No