Evaluation of Chest Physiotherapy for Acute Bronchiolitis in Toddlers (BRONKINOU) (BRONKINOU)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00125450 |
Recruitment Status :
Completed
First Posted : August 1, 2005
Last Update Posted : May 28, 2008
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Viral Bronchiolitis | Procedure: Chest Physiotherapy with Forced Expiratory Technique Procedure: Nasopharyngeal Aspiration | Not Applicable |
Bronchiolitis is the most common lower respiratory infection in infants, and the respiratory condition leading to the majority of hospital admissions in young children. It is also probably the most common serious illness of childhood lacking evidence-based treatment. Evidence against the effectiveness of chest physiotherapy with vibration and postural drainage techniques has been described but forced expiratory technique, as described in France, has never been evaluated.
The investigators hypothesised that forced expiratory technique was able to reduce the duration of respiratory distress.
Comparison(s): The investigators compare physiotherapy with forced expiratory techniques to simple aspiration of naso-pharyngeal secretions.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 500 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Care Provider, Investigator) |
Primary Purpose: | Treatment |
Official Title: | Efficacy and Safety of Chest Physiotherapy With Forced Expiratory Technique for Acute Bronchiolitis in Toddlers |
Study Start Date : | September 2004 |
Actual Primary Completion Date : | February 2008 |
Actual Study Completion Date : | February 2008 |

Arm | Intervention/treatment |
---|---|
Experimental: A
Chest Physiotherapy with Forced Expiratory Technique
|
Procedure: Chest Physiotherapy with Forced Expiratory Technique
Chest Physiotherapy with Forced Expiratory Technique
Other Name: A. Chest Physiotherapy with Forced Expiratory Technique |
Active Comparator: B
Aspiration
|
Procedure: Nasopharyngeal Aspiration
Nasopharyngeal Aspiration |
- Delay for obtention of healing defined by all of these parameters at least 8 hours in a row : pulse oxymétry >94% AND normal feeding AND specific respiratory distress score lower than one as described in the protocol AND normal respiratory rate [ Time Frame: obtention ]
- Safety of the forced expiratory technique [ Time Frame: during hospitalisation ]
- Comparison of pulse oxymetry before/after chest physiotherapy [ Time Frame: during hospitalisation ]
- Quality of Life Scale [ Time Frame: on discharge ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 15 Days to 24 Months (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Child aged 15 days to 24 months
- First acute bronchiolitis
- Indication of hospitalisation
- One or more of these criteria : toxic aspect; apnea or cyanosis; respiratory rate > 60/min; pulse oxymetry < 95%; alimentary intake < 2/3 of the needs.
Exclusion Criteria:
- Prematurity (gestational age < 32 weeks)
- Brondysplasia
- Chronic lung disease or congenital heart disease
- Respiratory distress necessitating admission in the Pediatric Intensive Care Unit (PICU)
- 3 or more chest physiotherapy procedures since hospitalisation
- Parental refusal
- Any chest physiotherapy contra-indication

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00125450
France | |
Jean Verdier Hospital | |
Bondy, France, 93140 | |
Ambroise Paré Hospital | |
Boulogne Billancourt, France, 92100 | |
Antoine Béclère Hospital - Pediatric Department | |
Clamart, France, 92140 | |
Kremlin Bicetre Hospital | |
Le Kremlin Bicetre, France, 94270 | |
Trousseau Hospital | |
Paris, France, 75012 | |
Necker - Enfants Malades Hospital | |
Paris, France, 75015 | |
Robert Debré Hospital | |
Paris, France, 75019 |
Principal Investigator: | Vincent Gajdos, MD | Assistance Publique - Hôpitaux de Paris | |
Study Director: | Philippe Labrune, MD - PhD | Assistance Publique - Hôpitaux de Paris |
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Marc LEGRAND, Department Clinical Research of Developpemnt |
ClinicalTrials.gov Identifier: | NCT00125450 |
Other Study ID Numbers: |
P030421 AOM 03123 DGS 2004/0276 |
First Posted: | August 1, 2005 Key Record Dates |
Last Update Posted: | May 28, 2008 |
Last Verified: | October 2006 |
Acute Bronchiolitis Chest Physiotherapy Forced Expiratory Techniques Double Blind Trial |
Children Pediatric RESPIRATORY SYNCYTIAL VIRUS |
Bronchiolitis Bronchiolitis, Viral Bronchitis Respiratory Tract Infections Infections |
Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases Virus Diseases |