Status:
UNKNOWN
Evaluation of the Effects of Respiratory Physiotherapy in Infants With Moderate Acute Bronchiolitis
Lead Sponsor:
Réseau Kinésithérapie Bronchiolite Essonne
Conditions:
Acute Bronchiolitis
Eligibility:
All Genders
3-24 years
Phase:
NA
Brief Summary
Bronchiolitis affects 460,000 children in France per year. The French study called "Bronkilib 2" found a positive effect of chest physiotherapy treatment. This study and the work done so far in chest ...
Detailed Description
Bronchiolitis affects 460,000 children in France per year. The French study called "Bronkilib 2" found a positive effect of chest physiotherapy treatment. This study and the work done so far in chest ...
Eligibility Criteria
Inclusion
- Acute bronchiolitis diagnosed during a medical consultation in one of the centres and medical agreement: the prescription must be based on clinical diagnosis of bronchiolitis proposed by the Guideline of the Academy of Pediatrics (AAP), i.e. the presence of rhinorrhea, cough, wheezing or rales crinkly, tachypnea, intercostal or chest indrawing, use of accessory muscles, flapping of the wings of the nose, expiratory grunting, lowest oxygen saturation (strictly less than 95%). The presence of three of these signs is enough to make the diagnosis of infant acute bronchiolitis.
- First or second episode of bronchiolitis: three episodes of bronchiolitis in the same winter suggest infant asthma, or the presence of other respiratory disease. To avoid any selection bias which might have a negative impact on the results of the study, only the first or second episode of bronchiolitis will be included.
- 3 months ≤ age ≤ 24 months: children of less than three months have a very immature lung. To avoid any worsening of the health condition of the child, related to potential but not considered side effects of the treatment, the study will be conducted on children over 3 months old.
- 3 \< Wang's score \< 9: bronchiolitis is considered light when Wang's score is less than or equal to 3 and as severe when Wang's score is greater than or equal to 9. The French Health Authority and the Cochrane discourage chest physiotherapy for the treatment of severe bronchiolitis. A hospital medical support is more adequate than a liberal support for this type of patient. They will not be included in the study.
- Informed written consent of the holders of parental authority: an information and consent form will be read and explained to the holders of parental authority before collecting their written consent during the interview with the prescribing physician. Consent will be collected by the physiotherapist on call of the investigative Centre, to let a cooling-off period for the holders of parental authority.
Exclusion
- Refusal of parents or holders of parental authority.
- No medical prescription: will only be included in the study children whose health can in no respect be endangered by their inclusion.
- Comorbidities: cardiac, pulmonary, neurological disease, immunodeficiency, congenital anomaly, other diseases explaining respiratory symptoms: the presence of comorbidities is likely to introduce a selection or a confusion bias in the results of the study. These patients will not be included in the study.
- Wang's score ≤ 3 or ≥ 9: a score ≥ 9 requires a hospitalization.
- Status of the child requiring hospitalization.
- No affiliation to a social security scheme.
Key Trial Info
Start Date :
December 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 30 2022
Estimated Enrollment :
168 Patients enrolled
Trial Details
Trial ID
NCT03753802
Start Date
December 1 2019
End Date
March 30 2022
Last Update
January 10 2020
Active Locations (3)
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1
Maison de Santé Pluri professionnelle Les allées
Corbeil-Essonnes, Essonne, France, 91100
2
Cabinet Pédiatrique Saint-Germain
Saint-Germain-lès-Arpajon, Essonne, France, 91180
3
MSP Léonie Chaptal
Athis-Mons, France, 91200