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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00125450 |
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Date of registration:
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29/07/2005 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Evaluation of Chest Physiotherapy for Acute Bronchiolitis in Toddlers (BRONKINOU)
BRONKINOU |
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Scientific title:
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Efficacy and Safety of Chest Physiotherapy With Forced Expiratory Technique for Acute Bronchiolitis in Toddlers |
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Date of first enrolment:
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September 2004 |
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Target sample size:
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500 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00125450 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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Phase:
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N/A
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Countries of recruitment
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France
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Contacts
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Name:
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Philippe Labrune, MD - PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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AP-HP |
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Name:
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Vincent Gajdos, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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AP-HP |
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Key inclusion & exclusion criteria
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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
Age minimum:
N/A
Age maximum:
24 Months
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Viral Bronchiolitis
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Intervention(s)
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Procedure: Nasopharyngeal Aspiration
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Procedure: Chest Physiotherapy with Forced Expiratory Technique
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Primary Outcome(s)
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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]
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Secondary Outcome(s)
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Safety of the forced expiratory technique
[Time Frame: during hospitalisation]
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Quality of Life Scale
[Time Frame: on discharge]
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Comparison of pulse oxymetry before/after chest physiotherapy
[Time Frame: during hospitalisation]
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Secondary ID(s)
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P030421
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AOM 03123
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DGS 2004/0276
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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