Trial record 1 of 1 for:
00125450
Evaluation of Chest Physiotherapy for Acute Bronchiolitis in Toddlers (BRONKINOU)
This study has been completed.
Sponsor:
Assistance Publique - Hôpitaux de Paris
Collaborator:
Association des réseaux Bronchiolite
Information provided by:
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00125450
First received: July 29, 2005
Last updated: May 26, 2008
Last verified: October 2006
| Tracking Information | |||||||||
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| First Received Date ICMJE | July 29, 2005 | ||||||||
| Last Updated Date | May 26, 2008 | ||||||||
| Start Date ICMJE | September 2004 | ||||||||
| Primary Completion Date | February 2008 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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 ] [ Designated as safety issue: Yes ] | ||||||||
| Original Primary Outcome Measures ICMJE |
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| Change History | Complete list of historical versions of study NCT00125450 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Evaluation of Chest Physiotherapy for Acute Bronchiolitis in Toddlers (BRONKINOU) | ||||||||
| Official Title ICMJE | Efficacy and Safety of Chest Physiotherapy With Forced Expiratory Technique for Acute Bronchiolitis in Toddlers | ||||||||
| Brief Summary | The purpose of this study is to determine whether chest physiotherapy with forced expiratory technique reduces delay of healing in acute bronchiolitis of children between 15 days and 24 months of age. |
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| Detailed Description | 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. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Not Provided | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
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| Condition ICMJE | Viral Bronchiolitis | ||||||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Perrotta C, Ortiz Z, Roque M. Chest physiotherapy for acute bronchiolitis in paediatric patients between 0 and 24 months old. Cochrane Database Syst Rev. 2005 Apr 18;(2):CD004873. Review. | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Completed | ||||||||
| Enrollment ICMJE | 500 | ||||||||
| Completion Date | February 2008 | ||||||||
| Primary Completion Date | February 2008 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | up to 24 Months | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | France | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00125450 | ||||||||
| Other Study ID Numbers ICMJE | P030421, AOM 03123, DGS 2004/0276 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | Marc LEGRAND, Department Clinical Research of Developpemnt | ||||||||
| Study Sponsor ICMJE | Assistance Publique - Hôpitaux de Paris | ||||||||
| Collaborators ICMJE | Association des réseaux Bronchiolite | ||||||||
| Investigators ICMJE |
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| Information Provided By | Assistance Publique - Hôpitaux de Paris | ||||||||
| Verification Date | October 2006 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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