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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
Sponsor:
Information provided by (Responsible Party):
Aurore TREBUCHET, Réseau Kinésithérapie Bronchiolite Essonne

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 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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 168 participants
Allocation: Randomized
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.
Primary Purpose: Treatment
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

Arm Intervention/treatment
Experimental: Treated
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.
Other: Surveillance
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.




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   3 Months to 24 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

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


Contacts
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Contact: Thomas BAUCHER +33683222558 thomas.baucher@wanadoo.fr

Locations
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France
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         
Sponsors and Collaborators
Réseau Kinésithérapie Bronchiolite Essonne
Investigators
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Principal Investigator: Thomas BAUCHER Réseau Kinésithérapie Bronchiolite Essonne
  Study Documents (Full-Text)

Documents provided by Aurore TREBUCHET, Réseau Kinésithérapie Bronchiolite Essonne:

Publications:

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Responsible Party: Aurore TREBUCHET, Clinical Manager, Réseau Kinésithérapie Bronchiolite Essonne
ClinicalTrials.gov Identifier: NCT03753802    
Other Study ID Numbers: 2018-A00946-49
First Posted: November 27, 2018    Key Record Dates
Last Update Posted: January 10, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Collected individual participant data
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: After publication
Access Criteria: Collected individual participant data shared upon request for Meta-analyses or other publications, co-decided by the sponsor (RKBE) and the investigators of the study.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Aurore TREBUCHET, Réseau Kinésithérapie Bronchiolite Essonne:
Bronchiolitis
Chest physiotherapy
Infants
Additional relevant MeSH terms:
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Bronchiolitis
Bronchitis
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections