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

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ClinicalTrials.gov Identifier: NCT04135430
Recruitment Status : Recruiting
First Posted : October 22, 2019
Last Update Posted : July 9, 2020
Sponsor:
Information provided by (Responsible Party):
Association des Réseaux Bronchiolite

Tracking Information
First Submitted Date September 30, 2019
First Posted Date October 22, 2019
Last Update Posted Date July 9, 2020
Actual Study Start Date October 14, 2019
Estimated Primary Completion Date April 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 21, 2019)
QUALIN score [ Time Frame: 24 hours ]
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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: October 21, 2019)
  • Questionnaire about accessibility of the care chain [ Time Frame: 8 days ]
    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.
  • Questionnaire about understanding of the information [ Time Frame: 8 days ]
    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
  • Questionnaire about perceived professional competence. [ Time Frame: 8 days ]
    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
  • Questionnaire about security of care [ Time Frame: 8 days ]
    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
  • Questionnaire about child's respiratory comfort [ Time Frame: 8 days ]
    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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Infants up to 12 months of age with first or second episode bronchiolitis
Condition Bronchiolitis
Intervention Other: Survey
practice of an updated questionnaire at D0, D2 and D7
Study Groups/Cohorts Survey
Practice of an updated questionnaire at D0, D2 and D7
Intervention: Other: Survey
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: October 21, 2019)
1500
Original Estimated Enrollment Same as current
Estimated Study Completion Date May 2021
Estimated Primary Completion Date April 2021   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages up to 1 Year   (Child)
Accepts Healthy Volunteers No
Contacts
Contact: Didier EVENOU, MD 0660946700 ext +33 devenou@orange.fr
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT04135430
Other Study ID Numbers BRONKILIB3
2019-A01633-54 ( Other Identifier: ID-RCB )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Association des Réseaux Bronchiolite
Study Sponsor Association des Réseaux Bronchiolite
Collaborators Not Provided
Investigators Not Provided
PRS Account Association des Réseaux Bronchiolite
Verification Date July 2020