Acute Bronchiolitis Clinical Trial
Official title:
Multicenter Randomized Controlled Trial: Evaluation of the Effects of Respiratory Physiotherapy, Placebo-controlled, in Infants With Moderate Acute Bronchiolitis
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.
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 only randomized trial on French
techniques of chest physiotherapy concerning outpatients is "Bronkilib 2", pending
publication. It is therefore the second such study in France that will corroborate or
invalidate the results of the "Bronkilib 2" study.
The study included infants with a first or a second episode of bronchiolitis classified as
moderate according to the Wang's Respiratory score (3 <score <9). The treated group will
receive chest physiotherapy treatment using slow extended and passive expiratory handlings.
The control group will not receive physiotherapy treatment. To control parents' home care and
ensure comparability of groups, an education session to the rhinopharyngeal clearance
procedure will be conducted in both groups.
The study will be conducted during 4 days per participant. The study will evaluate the Wang's
Respiratory score change measured between day 1 and day 4 and the evolution of the general
health condition of the infant between sessions. The study will also evaluate the saturation,
the results of a human Respiratory Syncytial Virus (RSV) nasal swab test, and the "inflamed /
secretory" status of children. The Wang's Respiratory score, the saturation and the
inflamed/secretory status will be collected through questionnaires available on the website
of the study. The general health condition of the infants will be collected by the QUALIN
questionnaire given to the parents.
The study will be conducted as follow:
A study session begins on Friday of week 0, children may be included on Monday or Tuesday of
the following week (week 1). The session ends on the next Friday (week 1). Children entered
on Monday are seen until Thursday, children entered on Tuesday are seen until Friday.
Children can have a prescription dating back to Monday or Tuesday, or the previous week
(Friday or Saturday).
The day 0 is the day where the child is greeted by the prescribing physician, general
practitioner or paediatrician of the family. Its role is to inform the parents of the child
of the existence of the study. This includes: checking the criteria of inclusion and
exclusion, including Wang's Respiratory score; explaining the course of the study; providing
the patient with an information letter, a consent letter and letters of no objection; giving
him the treatment prescription; giving them the access information to the center and the
phone number of the physiotherapist (which they have to call without delay on the first
scheduled day); and answering their questions.
Parents have the right to a cooling-off period (minimum 1 hour). Nevertheless, the entry in
the study cannot occur after Tuesday of the study week, and without prior consultation with
other physiotherapists. Parents wishing to integrate the study are to call the
physiotherapist indicated by the prescribing physician for an appointment.
Day 1 is a Monday or a Tuesday. The child is greeted by the physiotherapist who is expected
to: schedule the appointment with the parents either by phone or in person, collect at least
a consent letter, collect the letters of no objection, answer the questions of parents,
remind that the consent of both legal guardians is required, if not the case inform them that
they will be re-contacted by the principal investigator due to this missing writing consent.
Then the physiotherapist has to enter the child name in the database via the study website to
receive the child code which will be given to the parent. Thus, the child gets a code which
will be then the only way to recognize him/her. The physiotherapist asks the evaluating
physician to evaluate the Wang's Respiratory score of the day 1.
The evaluating physician comes into the physiotherapy room to: check that the child meets the
criteria for inclusion in the study (no worsening of the general condition and Wang's
Respiratory score < 9), evaluate the first assessment by the Wang's Respiratory score. This
evaluation is filled on the study website with the identifiers of the physician and the
child. Then the physician leaves the room.
Then, the physiotherapist performs the RSV nasal swab test. He has the parents perform the
rhinopharyngeal clearance to verify that the procedure is known and correct. He gives the
QUALIN questionnaire to the parents. He then asks the parents to leave the room for the
session and asks the website to randomize the treatment. The treatment to be applied is then
displayed on the screen, it is visible on the page dedicated to physiotherapists. Physicians
have no access to this information. Then the physiotherapist performs the treatment provided
by the randomization.
Randomization is performed at this time in order to avoid a randomization of treatment on
children who would get out of the study before the session of physiotherapy, which would
create a risk of imbalance between upstream groups.
During the physiotherapy session, parents in the waiting room fill in the QUALIN
questionnaire they will hand over to the physiotherapist after the session. Parents are not
present in the physiotherapy room during the sessions. The physiotherapist fills balance
sheets of saturation for all children and the status of the child (inflamed / secreting) for
children in the treatment group.
Day 2, 3 and 4 the child is seen again by the evaluating physician for a Wang's Respiratory
score: prior to the session of physiotherapy or surveillance for days 2 and 3, 30 minutes
after the session for the day 4. The balance sheets of saturation (at T30 the day 4) and
status of the child (inflamed / secreting) are again filled by the physiotherapist. The
parents fill in the questionnaire QUALIN in the waiting room during sessions.
Day 4, the study session is over. The evaluating physician suggests the continuation or
cessation of sessions of chest physiotherapy, depending on the health state of the child
during its last evaluation of the Wang's Respiratory score.
Evaluating physicians and physiotherapists are present from Monday to Friday (13 h to 19 h).
Each Center has at least one physician present every day during this period. Each Center has
a physiotherapist on call every day during this period.
The side effects or the non presentation of the child at the session can be collected at any
time of the study by: the evaluating physician and physiotherapist on the study website and
via the dedicated tab. The information is then sent directly to the proponent, the principal
investigator and coordinating physician. If there is a hospitalization, an emergency
unblinding can be made by the proponent, the principal investigator or the Coordinating
doctor who will be notified by mail and phone: the guardians are informed by mail and/or
phone of the treatment received and results of the assessments made.
If the child is getting worse: if Wang's Respiratory score ≥ 9 or if the child's condition
becomes cause for concern during the assessment carried out by the evaluating physician
(child receptive, amorphous, signs of respiratory distress associated with a frequency
respiratory > 60 breaths / minutes, signs of cyanosis, saturation ≤ 94%), the child must be
taken out of the study and sent to a hospital. If this takes place during the session of
physiotherapy, physiotherapist must ask the evaluating physician an assessment. An emergency
unblinding is made by the proponent, the principal investigator or coordinating physician.
These criteria of aggravation are recalled on the study website when filling out the balance
sheet by therapists. If the criteria are met the site visually alerts the therapist and
suggests him to go to the 'side effects' tab. The physiotherapist and the evaluating
physician can at any time report such signs.
If one of the guardians wishes to get out of the study, he informs the evaluating physician
or the physiotherapist or some other official who report it on the study website. The reason
for getting out of the study will be sought by the principal investigator without pressure.
Legal guardians have the right to wish not to report the reason why they get out of the
study. If the child is not present at the scheduled appointments or during the day, this will
be reported by the physiotherapist since it will take the child out of the study.
It is expected to treat 168 subjects, that is to say 84 subjects per group, over the two
medical centers. This will allow to perform the statistical analyses (Chi2). The number of
subjects has been estimated based on the results of the French "Bronkilib 2" study and
Postiaux study.
The results will be presented in descriptive statistics by diagrams and box plots. The
inferential statistics used will be: the Chi2 test to evaluate the intensity of the change in
the Wang's Respiratory score between day 1 and day 4, the Logrank test to evaluate the change
in the general health condition of the child (QUALIN questionnaire) during the four days of
the study, the Smirnov test to evaluate the change in the oxygen saturation during the four
days of the study. The Chi2 test will be performed using stratification on RSV status and
inflamed/secretory status. A Principal Components Analysis will be performed to identify
which items of the QUALIN score (so of the general health condition of the child) have been
impacted by the chest physiotherapy. The potential relation between the Wang's Respiratory
score and the QUALIN questionnaire will be estimated by the Kendall correlation coefficient.
Missing data will be estimated by imputation, either using prior data or information
collected on why the participant got out of the study.
The study can be stopped at any moment by the French Committee for the Protection of Persons
(CPP), or by the French Authority for Medication and Biomedical Research (ANSM).
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