Informations générales (source: ClinicalTrials.gov)
Multicenter Randomized Controlled Trial: Evaluation of the Effects of Respiratory Physiotherapy, Placebo-controlled, in Infants With Moderate Acute Bronchiolitis (Bronkiville)
Interventional
N/A
Réseau Kinésithérapie Bronchiolite Essonne (Voir sur ClinicalTrials)
décembre 2019
mars 2022
29 juin 2024
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 physiotherapy prompt us to recommend respiratory
physiotherapy with slow passive expiratory handlings in the treatment of the moderate
bronchiolitis of infants. But, further studies are still needed to corroborate these
early findings. The Cochrane is recommending new high-level proof studies on passive
expiratory techniques to conclude about their benefits.
The aim of this study is to evaluate the effectiveness of the bronchial drainage
procedure carried out during chest physiotherapy sessions, during episodes of moderate to
acute bronchiolitis in infants aged 3 to 24 months. Currently, the French High Authority
for Health recommends performing physiotherapy sessions for the symptomatologic treatment
of acute bronchiolitis in infants - in cases where it could be described as moderate -
but few studies have demonstrated the efficacy of this treatment.
The study included infants with a first or a second episode of bronchiolitis classified
as moderate according to the Wang's Respiratory score. The treated group will receive
chest physiotherapy treatment using slow extended and passive expiratory handlings. The
control group will not receive physiotherapy treatment. The study will be conducted
during 4 days. The clinical symptoms and the general health condition of the infant will
be evaluate by questionnaires.
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CHI POISSY ST-GERMAIN | Thomas BAUCHER | Contact (sur clinicalTrials) | |||
| CTRE EXAMENS SANTE CORBEIL ESSONNES | Tarek HUSSEIN | Contact (sur clinicalTrials) | |||
| I.F.S.I. LEONIE CHAPTAL | Jan LITWIN STASZEWSKI | Contact (sur clinicalTrials) | |||
Critères
Tous
Inclusion Criteria:
- 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.
- 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.
- 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.