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

NCT03753802 | Unknown

• 1 other identifier: 2018-A00946-49
• Study Type: interventional
• Target: 168
• Locations: 1 country
• Sites: 3

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.

Conditions

Acute Bronchiolitis

Keywords

Bronchiolitis; Chest physiotherapy; Infants

Outcome Measures

Primary Outcomes (2)

• Change of the Wang's Respiratory score between day 4 and day 1

  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.

  Each day, before the physiotherapy session for the day 1 to 3, after for the day 4.

• 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.

  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.

Secondary Outcomes (1)

• Change in Oxygen saturation between day 4 and day 1, and between day 2 and day 1

  Each day, before the physiotherapy session for the day 1 to 3, after for the day 4.

Study Arms (2)

Treated

EXPERIMENTAL

The treated group will receive chest physiotherapy treatment using slow extended and passive expiratory maneuvers.

Other: Chest Physiotherapy

Control

PLACEBO COMPARATOR

The control group will not receive physiotherapy treatment.

Other: Surveillance

Interventions

Chest Physiotherapy OTHER

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.

Treated

Surveillance OTHER

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.

Control

Eligibility Criteria

• Age: 3 Months - 24 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.
• 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.
• \< 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.

You may not qualify if:

• Refusal of parents or holders of parental authority.
• 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.

Sponsors & Collaborators

• Réseau Kinésithérapie Bronchiolite Essonne: lead

Study Sites (3)

Maison de Santé Pluri professionnelle Les allées

Corbeil-Essonnes, Essonne, 91100, France

RECRUITING

Cabinet Pédiatrique Saint-Germain

Saint-Germain-lès-Arpajon, Essonne, 91180, France

RECRUITING

MSP Léonie Chaptal

Athis-Mons, 91200, France

RECRUITING

Related Publications (12)

• Postiaux G, Louis J, Labasse HC, Gerroldt J, Kotik AC, Lemuhot A, Patte C. Evaluation of an alternative chest physiotherapy method in infants with respiratory syncytial virus bronchiolitis. Respir Care. 2011 Jul;56(7):989-94. doi: 10.4187/respcare.00721. Epub 2011 Feb 22.

  PMID: 21352671 BACKGROUND

• Remondini R, Santos AZ, Castro Gd, Prado Cd, Silva Filho LV. Comparative analysis of the effects of two chest physical therapy interventions in patients with bronchiolitis during hospitalization period. Einstein (Sao Paulo). 2014 Oct-Dec;12(4):452-8. doi: 10.1590/S1679-45082014AO3230.

  PMID: 25628196 BACKGROUND

• S Goncalves RA, Feitosa S, de Castro Selestrin C, Valenti VE, de Sousa FH, F Siqueira AA, Petenusso M, de Abreu LC. Evaluation of physiological parameters before and after respiratory physiotherapy in newborns with acute viral bronchiolitis. Int Arch Med. 2014 Jan 8;7(1):3. doi: 10.1186/1755-7682-7-3.

  PMID: 24401198 BACKGROUND

• Postiaux G, Zwaenepoel B, Louis J. Chest physical therapy in acute viral bronchiolitis: an updated review. Respir Care. 2013 Sep;58(9):1541-5. doi: 10.4187/respcare.01890. Epub 2013 Jan 3.

  PMID: 23287014 BACKGROUND

• Pupin MK, Riccetto AG, Ribeiro JD, Baracat EC. Comparison of the effects that two different respiratory physical therapy techniques have on cardiorespiratory parameters in infants with acute viral bronchiolitis. J Bras Pneumol. 2009 Sep;35(9):860-7. doi: 10.1590/s1806-37132009000900007. English, Portuguese.

  PMID: 19820812 BACKGROUND

• Sanchez Bayle M, Martin Martin R, Cano Fernandez J, Martinez Sanchez G, Gomez Martin J, Yep Chullen G, Garcia Garcia MC. [Chest physiotherapy and bronchiolitis in the hospitalised infant. Double-blind clinical trial]. An Pediatr (Barc). 2012 Jul;77(1):5-11. doi: 10.1016/j.anpedi.2011.11.026. Epub 2012 Jan 26. Spanish.

  PMID: 22281403 BACKGROUND

• Ralston SL, Lieberthal AS, Meissner HC. Ralston SL, Lieberthal AS, Meissner HC, et al. Clinical Practice Guideline: The Diagnosis, Management, and Prevention of Bronchiolitis. Pediatrics. 2014;134(5):e1474-e1502. Pediatrics. 2015 Oct;136(4):782. doi: 10.1542/peds.2015-2862. No abstract available.

  PMID: 26430140 BACKGROUND

• Roque i Figuls M, Gine-Garriga M, Granados Rugeles C, Perrotta C, Vilaro J. Chest physiotherapy for acute bronchiolitis in paediatric patients between 0 and 24 months old. Cochrane Database Syst Rev. 2016 Feb 1;2(2):CD004873. doi: 10.1002/14651858.CD004873.pub5.

  PMID: 26833493 BACKGROUND

• Wang EE, Milner RA, Navas L, Maj H. Observer agreement for respiratory signs and oximetry in infants hospitalized with lower respiratory infections. Am Rev Respir Dis. 1992 Jan;145(1):106-9. doi: 10.1164/ajrccm/145.1.106.

  PMID: 1731571 BACKGROUND

• Gomes GR, Calvete FP, Rosito GF, Donadio MV. Rhinopharyngeal Retrograde Clearance Induces Less Respiratory Effort and Fewer Adverse Effects in Comparison With Nasopharyngeal Aspiration in Infants With Acute Viral Bronchiolitis. Respir Care. 2016 Dec;61(12):1613-1619. doi: 10.4187/respcare.04685. Epub 2016 Aug 23.

  PMID: 27555618 BACKGROUND

• Manificat S, Dazord A, Langue J, Danjou G, Bauche P, Bovet F, Cubells J, Luchelli R, Tockert E, Conway K. [Evaluation of the quality of life of infants and very young children: validation of a questionnaire. Multicenter European study]. Arch Pediatr. 2000 Jun;7(6):605-14. doi: 10.1016/s0929-693x(00)80127-x. French.

  PMID: 10911526 BACKGROUND

• Roque-Figuls M, Gine-Garriga M, Granados Rugeles C, Perrotta C, Vilaro J. Chest physiotherapy for acute bronchiolitis in paediatric patients between 0 and 24 months old. Cochrane Database Syst Rev. 2023 Apr 3;4(4):CD004873. doi: 10.1002/14651858.CD004873.pub6.

  PMID: 37010196 DERIVED

MeSH Terms

Conditions

Bronchiolitis

Condition Hierarchy (Ancestors)

Bronchitis; Respiratory Tract Infections; Infections; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases

Study Officials

• Thomas BAUCHER

  Réseau Kinésithérapie Bronchiolite Essonne

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Thomas BAUCHER

CONTACT

+33683222558; thomas.baucher@wanadoo.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Manager

Model Details: The treated group will receive respiratory physiotherapy treatment using slow extended and passive expiratory maneuvers. The control group will not receive physiotherapy treatment.

Study Record Dates

• First Submitted: October 29, 2018
• First Posted: November 27, 2018
• Study Start: December 1, 2019
• Primary Completion: March 30, 2022
• Study Completion: March 30, 2022
• Last Updated: January 10, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, 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.

Locations

FR (3)