Evaluation of the Effects of Respiratory Physiotherapy in Infants With Moderate Acute Bronchiolitis

NCT03753802 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 168

Last updated 2020-01-10

No results posted yet for this study

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.

Conditions

  • Acute Bronchiolitis

Interventions

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.

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.

Sponsors & Collaborators

  • Réseau Kinésithérapie Bronchiolite Essonne

    lead OTHER

Principal Investigators

  • Thomas BAUCHER · Réseau Kinésithérapie Bronchiolite Essonne

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
3 Months
Max Age
24 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-01
Primary Completion
2022-03-30
Completion
2022-03-30

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03753802 on ClinicalTrials.gov