NCT03753802.
Study name | Multicentre, randomised controlled trial: evaluation of the effects of respiratory physiotherapy, placebo‐controlled, in infants with moderate acute bronchiolitis |
Methods | Randomised, quadruple‐blind, controlled clinical trial |
Participants | Infants aged 3 to 24 months, suffering a first or second episode of acute viral bronchiolitis of moderate severity (Wang's score > 3 and < 9), treated on an outpatient basis (N = 168) |
Interventions |
Group 1: chest physiotherapy: chest physiotherapy treatment using slow extended and passive expiratory manoeuvres Group 2 (control): no physiotherapy |
Outcomes | Primary outcomes: change of the Wang's Respiratory score between day 4 and day 1, time to improvement (up to 4 days), defined as an increase of 10 points from the QUALIN score (for child under 24 months of age) compared to the initial score. The QUALIN total score quotes the quality of life of the child from −68 to +68, with a negative score meaning that the child has a poor general health condition and quality of life, and a positive score meaning that the child has a good general health condition and quality of life. Secondary outcome measures: change in oxygen saturation |
Starting date | December 2019 |
Contact information | Aurore Trebuchet, Réseau Kinésithérapie Bronchiolite Essonne, France |
Notes | clinicaltrials.gov/ct2/show/NCT03753802 clinicaltrials.gov/ProvidedDocs/02/NCT03753802/Prot_SAP_ICF_002.pdf |