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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

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.


Condition or disease Intervention/treatment
Bronchiolitis 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.

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Study Type : Observational
Estimated Enrollment : 1500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Parental Assessment of the Quality of Life of Infants Under 12 Months of Age With Moderate Bronchiolitis Referred for Ambulatory Respiratory Physiotherapy
Actual Study Start Date : October 14, 2019
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : May 2021

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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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

  3. 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

  4. 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

  5. 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.



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Ages Eligible for Study:   up to 1 Year   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Infants up to 12 months of age with first or second episode bronchiolitis
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04135430


Contacts
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Contact: Didier EVENOU, MD 0660946700 ext +33 devenou@orange.fr

Locations
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France
Rb Picard Recruiting
Amiens, France
Contact: Bruno Pierre       bruno-pierre@orange.fr   
RB 74 Recruiting
Annecy-le-Vieux, France
Contact: Jean-Claude JEULIN       jeulinjc0@gmail.com   
GAB Recruiting
Arpajon, France
Contact: Pascale POIRET       papomo@wanadoo.fr   
Aquirespi Recruiting
Bordeaux, France
Contact: Marik FETHOU       marik.fetouh@gmail.com   
Rb Loiret Recruiting
Fleury-les-Aubrais, France
Contact: Marie-Laure STROIAZZO       mlistro@hotmail.fr   
La Rochelle Recruiting
La Rochelle, France
Contact: Aude Geldron       aude.geldron@live.fr   
Occirespi Recruiting
Léguevin, France
Contact: Line COUSTURES       l.coustures@gmail.com   
Rb Grand Est Recruiting
Malzéville, France
Contact: Corinne FRICHE       corinne.friche.kine@wanadoo.fr   
ARBAM Recruiting
Marseille, France
Contact: Jean-Fabien LAZARRO       jeanfabienlazaro@gmail.com   
CHU Robert-Debré Recruiting
Paris, France
Contact: Didier EVENOU       devenou@orange.fr   
RB 59 62 Recruiting
Seclin, France
Contact: Pia Delaby       pia.delaby@gmail.com   
Sponsors and Collaborators
Association des Réseaux Bronchiolite
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Responsible Party: Association des Réseaux Bronchiolite
ClinicalTrials.gov Identifier: NCT04135430    
Other Study ID Numbers: BRONKILIB3
2019-A01633-54 ( Other Identifier: ID-RCB )
First Posted: October 22, 2019    Key Record Dates
Last Update Posted: July 9, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Association des Réseaux Bronchiolite:
Bronchiolitis
Infants
Chest physiotherapy
Additional relevant MeSH terms:
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Bronchiolitis
Bronchitis
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections