Evaluation of the Effects of Respiratory Physiotherapy in Infants With Moderate Acute Bronchiolitis (Bronkiville)
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|ClinicalTrials.gov Identifier: NCT03753802|
Recruitment Status : Recruiting
First Posted : November 27, 2018
Last Update Posted : January 10, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Acute Bronchiolitis||Other: Chest Physiotherapy Other: Surveillance||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||168 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||The treated group will receive respiratory physiotherapy treatment using slow extended and passive expiratory maneuvers. The control group will not receive physiotherapy treatment.|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Masking Description:||The randomization will be performed by the study website and will be only known by the physiotherapist. The parents are not allowed to be in the room of physiotherapy during the physiotherapy session. They don't know which treatment is allocated to their child. The evaluator physician doesn't know which treatment is allocated to the child. The biostatistician doesn't know which treatment is allocated to which group during the analyses.|
|Official Title:||Multicenter Randomized Controlled Trial: Evaluation of the Effects of Respiratory Physiotherapy, Placebo-controlled, in Infants With Moderate Acute Bronchiolitis|
|Actual Study Start Date :||December 1, 2019|
|Estimated Primary Completion Date :||March 30, 2022|
|Estimated Study Completion Date :||March 30, 2022|
The treated group will receive chest physiotherapy treatment using slow extended and passive expiratory maneuvers.
Other: Chest Physiotherapy
During sessions, the child is lying on the back, he should not have eaten within two hours prior to the sessions. An extended slow expiration handling is performed on 3 respiratory cycles consecutive, this session is repeated for 10 minutes. Breaks are made regularly during the treatment to have approximately 5 to 6 minutes of handling and 4-5 minutes of rest on the total 10 minutes of treatment. Induced cough handlings will be conducted at five minutes and at ten minutes if the child has not coughed during the movements of chest physiotherapy. These are performed by a brief pressure above the jugular (suprasternal) notch of the patient. Only two consecutive trials of the induced cough handling are allowed, even if the handlings are unsuccessful the physiotherapist does not insist. The following 5 minutes of the session are 5 minutes of rest. During the sessions the physiotherapist wears a mask and respects the usual rules of hygiene.
Placebo Comparator: Control
The control group will not receive physiotherapy treatment.
The session is only a surveillance session with the physiotherapist. The physiotherapist is only watching over the child. The parents of the child wait in the waiting room during the physiotherapy session. They don't know which treatment (chest physiotherapy or no treatment) is applied to their child.
- Change of the Wang's Respiratory score between day 4 and day 1 [ Time Frame: Each day, before the physiotherapy session for the day 1 to 3, after for the day 4. ]The Wang's Respiratory score as previously described in the literature by Wang E.E, measures the clinical state of the child. It includes 4 items : respiratory rate (breaths/minute ; quoted from 0 to 3), wheezing (quoted from 0 to 3), retraction (quoted from 0 to 3) and general condition (quoted from 0 or 3). The Wang's Respiratory score quotes the clinical state of the child from 0 to 12, the clinical state being normal for a score of 0, and worrying for a score greater than or equal to 9.
- Time from the date of first measure until the date of first documented improvement (up to 4 days), defined as an increase of 10 points from the QUALIN score (for child under 24 months age old) compared to the initial score. [ Time Frame: Time from the date of first measure until the date of first documented improvement (up to 4 days), defined as an increase of 10 points from the QUALIN score (for child under 24 months age old) compared to the initial score. ]The QUALIN score measures the general health condition and the quality of life of the child. It will be fill out by the parents. The QUALIN score contains 34 items, evaluating the awakening state, the psychological and somatic behavior of the child. Each item can be quoted by the parents from completly true to completly false. The total score quotes the quality of life of the child from -68 to +68, a negative score meaning that the child have a poor general health condition and quality of life, a positive score meaning that the child have a good general health condition and quality of life.
- Change in Oxygen saturation between day 4 and day 1, and between day 2 and day 1 [ Time Frame: Each day, before the physiotherapy session for the day 1 to 3, after for the day 4. ]Oxygen saturation estimate by a pulse oximeter.
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): NCT03753802
|Contact: Thomas BAUCHERfirstname.lastname@example.org|
|Maison de Santé Pluri professionnelle Les allées||Recruiting|
|Corbeil-Essonnes, Essonne, France, 91100|
|Contact: Tarek HUSSEIN|
|Cabinet Pédiatrique Saint-Germain||Recruiting|
|Saint-Germain-lès-Arpajon, Essonne, France, 91180|
|Contact: Thomas BAUCHER|
|MSP Léonie Chaptal||Recruiting|
|Athis-Mons, France, 91200|
|Contact: Jan LITWIN STASZEWSKI|
|Principal Investigator:||Thomas BAUCHER||Réseau Kinésithérapie Bronchiolite Essonne|