BronchiolitisFIBARRIXNCT02458300
Clinical Evaluation of the Response to Chest Physiotherapy in Children With Acute Bronchiolitis
A study testing Nebulization of hypertonic saline, Prolonged slow expiration technique (PSE) and Patient coughing Provocation (TP) in people with Bronchiolitis, run by Universidad Católica San Antonio de Murcia.
Trial summary
The objective of this study is to evaluate the clinical response of children diagnosed with acute bronchiolitis, relative to a chest physiotherapy protocol. Comparing this treatment with standard care of the nursing staff and auxiliaries of infants patients aged 1 month to 2 years. Read more about this study
- Who is it for?
- Ages 1 month to 2 years
- Conditions the study is for
- Bronchiolitis
- What is being tested?
- Nebulization of hypertonic saline, Prolonged slow expiration technique (PSE) and Patient coughing Provocation (TP)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 77 participants
- Where
- No sites listed yet
- Study dates
- Jan 2015to Mar 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 2 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients admitted to the pediatric intensive care unit or pediatric nursing unit. Which they are diagnostic of acute viral bronchiolitis (AVB).
Who cannot join
- Presence of cyanotic congenital heart disease no longer for comparing the constants.
- Relative or absolute contraindication CPT techniques included in the protocol.
- Patients diagnosed with moderate or severe gastroesophageal reflux since the PSE gastroesophageal reflux can accentuate a previously exist.
- Patients with laryngeal diseases caused because the cough is a technique that is applied directly to the tracheal wall and can affect the larynx.
- Absence of cough reflects and presence of laryngeal stridor is a contraindication to chest physiotherapy in general.
- Systematic presence of gag reflex as the aspiration of secretions and coughing caused nasobucales stimulate this reflex
About this study
Official title: FIBARRIX "Clinical Evaluation of the Response to Chest Physiotherapy in Infants With Acute Bronchiolitis"
The objective of this study is to evaluate the clinical response of children diagnosed with acute bronchiolitis, relative to a chest physiotherapy protocol. Comparing this treatment with standard care of the nursing staff and auxiliaries of infants patients aged 1 month to 2 years.
Read the detailed description
This randomized clinical trial has an intervention group and a control group. All treatment will be made by physiotherapist with extensive clinical experience and training in techniques of Chest physiotherapy (CPT). Performing at least one session per day during the time of patient admission. This session takes an average of about 15 minutes, begins by fogging of hypertonic saline, and ends with the nasal and oral suction of the patient. The evaluation of clinical data is done 10 minutes before, 10 minutes later, 2 hours after physiotherapy treatment. The evaluation will be do it for a doctor who will, in all patients, a clinical examination that includes all items scale clinical severity of acute bronchiolitis.
Patient Registries:
SELECTION OF THE POPULATION Reference population. Patients diagnosed acute viral bronchiolitis during the conduct of the trial and have been admitted to the University Hospital Virgin of Arrixaca.
Sample size
The sample calculation was done considering a reduction of 2 points after physiotherapy in bronchiolitis severity scale. Whereas:
Variances: sames Detect mean difference: 2,000 Common standard deviation: 2,370 Ratio of sample sizes: 1,00 Confidence level: 95,0%
The standard deviation values were obtained from: JM Fernández Ramos et al Validation of a clinical scale of severity of acute bronchiolitis. An Pediatr (Barc). 2014; 81 (1): 3-8, article in which the mean and standard deviation (SD) score of patients admitted was 7 ± 2.37. There are no items to compare this scale before and after treatment, so the investigators have assumed that value of common standard deviation (SD) and whereas a decrease of 2 points on the scale post-physical therapy would be clinically relevant.
Power (%) Sample size Cases Control Total 85,0 27 27 54 90 31 31 62
Finally it was decided to increase to 60 cases / group considering that the number of losses may be higher (the investigators calculate 50%).
- Conditions
- Bronchiolitis
- Being tested
- Nebulization of hypertonic saline, Prolonged slow expiration technique (PSE), Patient coughing Provocation (TP), inspiratory maneuver to rhinopharyngeal cleaning DRR, Aspiration of secretions
- Keywords
- Bronchiolitis, Chest, Physical therapy
- Medical subject headings
- Bronchiolitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nebulization of hypertonic salineOther
application of hypertonic saline serum through a mask fogging or a box fogging
Prolonged slow expiration technique (PSE)Other
Passive expiratory aid implemented baby. the child is placed supine on a hard surface. Thoracoabdominal slow manual pressure that begins at the end of a spontaneous and continuous exhalation to residual volume is exercised. Oppose reaches 2 or 3 breaths. Vibrations can accompany the art. The goal is to achieve a greater expiratory volume.
Patient coughing Provocation (TP)Other
Tp is based on the mechanism reflects cough induced by stimulation of the buttons on the wall of the trachea extrathoracic mechanoreceptors. The child is placed supine. A short pressure is done with the thumb on the tracheal conduit (in the sternal notch) at the end of inspiration, or at the beginning of expiration. With the other hand holding the abdominal region we prevent the dissipation of energy and make the explosion tussive more effective. It is done after the PSE.
inspiratory maneuver to rhinopharyngeal cleaning DRROther
After the inspiratory reflection following the PSE, the TP or crying. At the end of expiratory time the child's mouth is closed with the back of his hand just finished his chest support, raising the jaw and forcing the child to an inspiration with the nose
Aspiration of secretionsOther
Suctioning with a probe by a vacuum system installed on the wall.
| Study group | Role | What they receive |
|---|---|---|
| Control Arm | Placebo comparator | Nebulized hypertonic saline. Aspiration of secretions Receives: Other: Nebulization of hypertonic saline; Other: Aspiration of secretions |
| Intervention Arm. | Active comparator | Nebulization of hypertonic saline. Application of Prolonged slow expiration technique (PSE) expiratory volume. Patient coughing Provocation (TP) Inspiratory maneuver to rhinopharyngeal cleaning DRR Aspiration of secretions Receives: Other: Nebulization of hypertonic saline; Other: Prolonged slow expiration technique (PSE); Other: Patient coughing Provocation (TP); Other: inspiratory maneuver to rhinopharyngeal cleaning DRR; Other: Aspiration of secretions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the effectiveness of a physiotherapy treatment with clinical severity scale of a patient diagnosed with acute viral bronchiolitis
Measured: Participants will be followed for the duration of hospital stay, an expected average of 7 days
Secondary outcomes (3)
Assess the variation of score, a scale of severity of acute viral bronchiolitis, after intervention protocols
Measured: Participants will be followed for the duration of hospital stay, an expected average of 7 days
Analyze a inquiry of subjective opinion, completed by parents or tutors at the end of treatment
A questionnaire was filled out by parents or guardians of patients. After, the results of the survey will be analyzed by means of SPSS software
Measured: Participants will be followed for the duration of hospital stay, an expected average of 7 days
To quantify the changes in clinical score severity scale.
Measured: Participants will be followed for the duration of hospital stay, an expected average of 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2015 (estimated)
- Study startJan 2015
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for BronchiolitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Católica San Antonio de Murcia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Enrique Conesa Segura, Universidad Católica San Antonio de Murcia
- Investigators
- Enrique E Conesa Segura, PT, Principal investigator, MurciaSaludSusana Beatriz S Reyes Dominguez, PhD,MD, Principal investigator, MurciaSaludJosé J Rios Diaz, PhD, BiolSc, PT, Study chair, Universidad Católica San Antonio de MurciaEduardo E Ramos Elbal, MD, Study chair, MurciaSaludCristina C Palazón Carpe, MD, Study chair, MurciaSaludMaria Ángeles M Ruiz Pacheco, MD, Study chair, MurciaSaludJaume J Enjuanes Llovet, MD, Study chair, MurciaSaludSara S Francés Tarazona, MD, Study chair, MurciaSalud
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02458300
- Sponsor's protocol ID
- FIBARRIX
- Acronym
- FIBARRIX
- Status last verified
- May 2015
- First submitted
- 20 May 2015
- Last updated
- 2 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Aherne W, Bird T, Court SD, Gardner PS, McQuillin J. Pathological changes in virus infections of the lower respiratory tract in children. J Clin Pathol. 1970 Feb;23(1):7-18. doi: 10.1136/jcp.23.1.7.
PubMed 4909103Bohe L, Ferrero ME, Cuestas E, Polliotto L, Genoff M. [Indications of conventional chest physiotherapy in acute bronchiolitis]. Medicina (B Aires). 2004;64(3):198-200. Spanish.
PubMed 15239532Fischer GB, Teper A, Colom AJ. Acute viral bronchiolitis and its sequelae in developing countries. Paediatr Respir Rev. 2002 Dec;3(4):298-302. doi: 10.1016/s1526-0542(02)00268-3.
PubMed 12457599Gajdos V, Katsahian S, Beydon N, Abadie V, de Pontual L, Larrar S, Epaud R, Chevallier B, Bailleux S, Mollet-Boudjemline A, Bouyer J, Chevret S, Labrune P. Effectiveness of chest physiotherapy in infants hospitalized with acute bronchiolitis: a multicenter, randomized, controlled trial. PLoS Med. 2010 Sep 28;7(9):e1000345. doi: 10.1371/journal.pmed.1000345.
PubMed 20927359Gomes EL, Postiaux G, Medeiros DR, Monteiro KK, Sampaio LM, Costa D. Chest physical therapy is effective in reducing the clinical score in bronchiolitis: randomized controlled trial. Rev Bras Fisioter. 2012 Jun;16(3):241-7. doi: 10.1590/s1413-35552012005000018. Epub 2012 Apr 12.
PubMed 22499404Hess DR. Airway clearance: physiology, pharmacology, techniques, and practice. Respir Care. 2007 Oct;52(10):1392-6.
PubMed 17894906Krause MF, Hoehn T. Chest physiotherapy in mechanically ventilated children: a review. Crit Care Med. 2000 May;28(5):1648-51. doi: 10.1097/00003246-200005000-00067.
PubMed 10834729Lanza FC, Wandalsen G, Dela Bianca AC, Cruz CL, Postiaux G, Sole D. Prolonged slow expiration technique in infants: effects on tidal volume, peak expiratory flow, and expiratory reserve volume. Respir Care. 2011 Dec;56(12):1930-5. doi: 10.4187/respcare.01067. Epub 2011 Jun 17.
PubMed 21682953McConnochie KM. Bronchiolitis. What's in the name? Am J Dis Child. 1983 Jan;137(1):11-3. No abstract available.
PubMed 6847951Mellins RB. Pulmonary physiotherapy in the pediatric age group. Am Rev Respir Dis. 1974 Dec;110(6 Pt 2):137-42. doi: 10.1164/arrd.1974.110.6P2.137. No abstract available.
PubMed 4613219Oberwaldner B. Physiotherapy for airway clearance in paediatrics. Eur Respir J. 2000 Jan;15(1):196-204. doi: 10.1183/09031936.00.15119600.
PubMed 10678646Postiaux 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.
PubMed 21352671Postiaux G. [Bronchiolitis in infants. What are the techniques of bronchial and upper airway respiratory therapy adapted to infants?]. Arch Pediatr. 2001 Jan;8 Suppl 1:117S-125S. doi: 10.1016/s0929-693x(01)80170-6. No abstract available. French.
PubMed 11232428Roque i Figuls M, Gine-Garriga M, Granados Rugeles C, Perrotta C. Chest physiotherapy for acute bronchiolitis in paediatric patients between 0 and 24 months old. Cochrane Database Syst Rev. 2012 Feb 15;(2):CD004873. doi: 10.1002/14651858.CD004873.pub4.
PubMed 22336805Schechter MS. Airway clearance applications in infants and children. Respir Care. 2007 Oct;52(10):1382-90; discussion 1390-1.
PubMed 17894905
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FIBARRIX "Clinical Evaluation of the Response to Chest Physiotherapy in Infants With Acute Bronchiolitis"
- ClinicalTrials.gov ID
- NCT02458300
- Acronym / sponsor ID
- FIBARRIX / FIBARRIX
- Conditions
- Bronchiolitis
- Keywords
- Bronchiolitis, Chest, Physical therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Universidad Católica San Antonio de MurciaUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 1 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to evaluate the clinical response of children diagnosed with acute bronchiolitis, relative to a chest physiotherapy protocol. Comparing this treatment with standard care of the nursing staff and auxiliaries of infants patients aged 1 month to 2 years.
Detailed description
This randomized clinical trial has an intervention group and a control group. All treatment will be made by physiotherapist with extensive clinical experience and training in techniques of Chest physiotherapy (CPT). Performing at least one session per day during the time of patient admission. This session takes an average of about 15 minutes, begins by fogging of hypertonic saline, and ends with the nasal and oral suction of the patient. The evaluation of clinical data is done 10 minutes before, 10 minutes later, 2 hours after physiotherapy treatment. The evaluation will be do it for a doctor who will, in all patients, a clinical examination that includes all items scale clinical severity of acute bronchiolitis.
Patient Registries:
SELECTION OF THE POPULATION Reference population. Patients diagnosed acute viral bronchiolitis during the conduct of the trial and have been admitted to the University Hospital Virgin of Arrixaca.
Sample size
The sample calculation was done considering a reduction of 2 points after physiotherapy in bronchiolitis severity scale. Whereas:
Variances: sames Detect mean difference: 2,000 Common standard deviation: 2,370 Ratio of sample sizes: 1,00 Confidence level: 95,0%
The standard deviation values were obtained from: JM Fernández Ramos et al Validation of a clinical scale of severity of acute bronchiolitis. An Pediatr (Barc). 2014; 81 (1): 3-8, article in which the mean and standard deviation (SD) score of patients admitted was 7 ± 2.37. There are no items to compare this scale before and after treatment, so the investigators have assumed that value of common standard deviation (SD) and whereas a decrease of 2 points on the scale post-physical therapy would be clinically relevant.
Power (%) Sample size Cases Control Total 85,0 27 27 54 90 31 31 62
Finally it was decided to increase to 60 cases / group considering that the number of losses may be higher (the investigators calculate 50%).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Arm | Placebo comparator | Other: Nebulization of hypertonic saline, Other: Aspiration of secretionsNebulized hypertonic saline. Aspiration of secretions |
| Intervention Arm. | Active comparator | Other: Nebulization of hypertonic saline, Other: Prolonged slow expiration technique (PSE), Other: Patient coughing Provocation (TP), Other: inspiratory maneuver to rhinopharyngeal cleaning DRR, Other: Aspiration of secretionsNebulization of hypertonic saline. Application of Prolonged slow expiration technique (PSE) expiratory volume. Patient coughing Provocation (TP) Inspiratory maneuver to rhinopharyngeal cleaning DRR Aspiration of secretions |
Who may qualify
- Ages
- 1 month to 2 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Patients admitted to the pediatric intensive care unit or pediatric nursing unit. Which they are diagnostic of acute viral bronchiolitis (AVB).
Key exclusion criteria (6 listed)
- Presence of cyanotic congenital heart disease no longer for comparing the constants.
- Relative or absolute contraindication CPT techniques included in the protocol.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nebulization of hypertonic salineapplication of hypertonic saline serum through a mask fogging or a box fogging | Other | Control Arm, Intervention Arm. |
| Prolonged slow expiration technique (PSE)Passive expiratory aid implemented baby. the child is placed supine on a hard surface. Thoracoabdominal slow manual pressure that begins at the end of a spontaneous and continuous exhalation to residual volume is exercised. Oppose reaches 2 or 3 breaths. Vibrations can accompany the art. The goal is to achieve a greater expiratory volume. | Other | Intervention Arm. |
| Patient coughing Provocation (TP)Tp is based on the mechanism reflects cough induced by stimulation of the buttons on the wall of the trachea extrathoracic mechanoreceptors. The child is placed supine. A short pressure is done with the thumb on the tracheal conduit (in the sternal notch) at the end of inspiration, or at the beginning of expiration. With the other hand holding the abdominal region we prevent the dissipation of energy and make the explosion tussive more effective. It is done after the PSE. | Other | Intervention Arm. |
| inspiratory maneuver to rhinopharyngeal cleaning DRRAfter the inspiratory reflection following the PSE, the TP or crying. At the end of expiratory time the child's mouth is closed with the back of his hand just finished his chest support, raising the jaw and forcing the child to an inspiration with the nose | Other | Intervention Arm. |
| Aspiration of secretionsSuctioning with a probe by a vacuum system installed on the wall. | Other | Control Arm, Intervention Arm. |
Primary outcome
Evaluate the effectiveness of a physiotherapy treatment with clinical severity scale of a patient diagnosed with acute viral bronchiolitis
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 7 days
3 secondary outcomes
Assess the variation of score, a scale of severity of acute viral bronchiolitis, after intervention protocols
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 7 days
Analyze a inquiry of subjective opinion, completed by parents or tutors at the end of treatment
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 7 days
To quantify the changes in clinical score severity scale.
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2016.
- Background: PubMed 4909103Aherne W, Bird T, Court SD, Gardner PS, McQuillin J. Pathological changes in virus infections of the lower respiratory tract in children. J Clin Pathol. 1970 Feb;23(1):7-18. doi: 10.1136/jcp.23.1.7.
- Background: PubMed 15239532Bohe L, Ferrero ME, Cuestas E, Polliotto L, Genoff M. [Indications of conventional chest physiotherapy in acute bronchiolitis]. Medicina (B Aires). 2004;64(3):198-200. Spanish.
- Background: PubMed 12457599Fischer GB, Teper A, Colom AJ. Acute viral bronchiolitis and its sequelae in developing countries. Paediatr Respir Rev. 2002 Dec;3(4):298-302. doi: 10.1016/s1526-0542(02)00268-3.
- Background: PubMed 20927359Gajdos V, Katsahian S, Beydon N, Abadie V, de Pontual L, Larrar S, Epaud R, Chevallier B, Bailleux S, Mollet-Boudjemline A, Bouyer J, Chevret S, Labrune P. Effectiveness of chest physiotherapy in infants hospitalized with acute bronchiolitis: a multicenter, randomized, controlled trial. PLoS Med. 2010 Sep 28;7(9):e1000345. doi: 10.1371/journal.pmed.1000345.
- Background: PubMed 22499404Gomes EL, Postiaux G, Medeiros DR, Monteiro KK, Sampaio LM, Costa D. Chest physical therapy is effective in reducing the clinical score in bronchiolitis: randomized controlled trial. Rev Bras Fisioter. 2012 Jun;16(3):241-7. doi: 10.1590/s1413-35552012005000018. Epub 2012 Apr 12.
- Background: PubMed 17894906Hess DR. Airway clearance: physiology, pharmacology, techniques, and practice. Respir Care. 2007 Oct;52(10):1392-6.
- Background: PubMed 10834729Krause MF, Hoehn T. Chest physiotherapy in mechanically ventilated children: a review. Crit Care Med. 2000 May;28(5):1648-51. doi: 10.1097/00003246-200005000-00067.
- Background: PubMed 21682953Lanza FC, Wandalsen G, Dela Bianca AC, Cruz CL, Postiaux G, Sole D. Prolonged slow expiration technique in infants: effects on tidal volume, peak expiratory flow, and expiratory reserve volume. Respir Care. 2011 Dec;56(12):1930-5. doi: 10.4187/respcare.01067. Epub 2011 Jun 17.
- Background: PubMed 6847951McConnochie KM. Bronchiolitis. What's in the name? Am J Dis Child. 1983 Jan;137(1):11-3. No abstract available.
- Background: PubMed 4613219Mellins RB. Pulmonary physiotherapy in the pediatric age group. Am Rev Respir Dis. 1974 Dec;110(6 Pt 2):137-42. doi: 10.1164/arrd.1974.110.6P2.137. No abstract available.
- Background: PubMed 10678646Oberwaldner B. Physiotherapy for airway clearance in paediatrics. Eur Respir J. 2000 Jan;15(1):196-204. doi: 10.1183/09031936.00.15119600.
- Background: PubMed 21352671Postiaux 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Enrique E Conesa Segura, PT principal investigator
MurciaSalud
Susana Beatriz S Reyes Dominguez, PhD,MD principal investigator
MurciaSalud
José J Rios Diaz, PhD, BiolSc, PT study chair
Universidad Católica San Antonio de Murcia
Questions about this trial
What is this clinical trial studying?
A study testing Nebulization of hypertonic saline, Prolonged slow expiration technique (PSE) and Patient coughing Provocation (TP) in people with Bronchiolitis, run by Universidad Católica San Antonio de Murcia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the effectiveness of a physiotherapy treatment with clinical severity scale of a patient diagnosed with acute viral bronchiolitis (time frame: Participants will be followed for the duration of hospital stay, an expected average of 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02458300, which also lists 20 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2016.