Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04135430 |
| Other study ID # |
BRONKILIB3 |
| Secondary ID |
2019-A01633-54 |
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
October 14, 2019 |
| Est. completion date |
April 4, 2021 |
Study information
| Verified date |
June 2021 |
| Source |
Association des Réseaux Bronchiolite |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
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.
