Acute Bronchiolitis Clinical Trial
— BronkivilleOfficial 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.
Status | Recruiting |
Enrollment | 168 |
Est. completion date | March 30, 2022 |
Est. primary completion date | March 30, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 3 Months to 24 Months |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
France | MSP Léonie Chaptal | Athis-Mons | |
France | Maison de Santé Pluri professionnelle Les allées | Corbeil-Essonnes | Essonne |
France | Cabinet Pédiatrique Saint-Germain | Saint-Germain-lès-Arpajon | Essonne |
Lead Sponsor | Collaborator |
---|---|
Réseau Kinésithérapie Bronchiolite Essonne |
France,
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. Epub 2016 Aug 23. — View Citation
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. French. — View Citation
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. — View Citation
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. Review. — View Citation
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. English, Portuguese. — View Citation
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. — View Citation
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. — View Citation
Roqué i Figuls M, Giné-Garriga M, Granados Rugeles C, Perrotta C, Vilaró J. Chest physiotherapy for acute bronchiolitis in paediatric patients between 0 and 24 months old. Cochrane Database Syst Rev. 2016 Feb 1;2:CD004873. doi: 10.1002/14651858.CD004873.pub5. Review. — View Citation
S Gonçalves 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. — View Citation
Sánchez Bayle M, Martín Martín R, Cano Fernández J, Martínez Sánchez G, Gómez Martín J, Yep Chullen G, García García 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. — View Citation
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. — View Citation
* Note: There are 11 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | |
Primary | 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 | Change in Oxygen saturation between day 4 and day 1, and between day 2 and day 1 | Oxygen saturation estimate by a pulse oximeter. | Each day, before the physiotherapy session for the day 1 to 3, after for the day 4. |
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