Influence of the Nebulizer on the Clinical Efficacy of Hypertonic Saline 3% in Children Aged Less Than 18 Months and Hospitalized With Acute Viral Bronchiolitis
NCT ID: NCT01295398
Last Updated: 2014-08-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
168 participants
INTERVENTIONAL
2010-12-31
2014-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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conventional jet-nebulizer
(particles diameter of 4-5 µm)
nebulisations
a jet-nebulizer adapted for infants
(particles diameter of 2-2.5 µm),
nebulisations
a mesh-nebulizer adapted for infants
(particles diameter of 2-2.5 µm).
nebulisations
Interventions
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nebulisations
Eligibility Criteria
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Inclusion Criteria
* infant hospitalized for a 1st episode of bronchiolitis defined as a 1st episode of respiratory difficulty with sibilant and\\or crépitants in a viral context (head cold and\\or cough and\\or fever and\\or notion of contage)
* Necessity of an clinical score upper to 4. This clinical score, described by Wang in 1992, is the clinical score classically used in the studies concerning the acute(sharp) bronchiolitis of the infant ( 8,9,12 ). He(it) is at most on 12 points.
* absence of respiratory décompensation requiring an admission in Unity of Pediatric Intensive care
* signature of the Informed consent
* Membership in a national insurance
Exclusion Criteria
* 18-month-old infant hospitalized for acute(sharp) bronchiolitis with a clinical score lower than 4.
* signs of respiratory décompensation requiring a transfer in resuscitation, signs of hypercapnie or episodes of apneas
* histories of bronchiolitis or asthma of the infant
* cardiac underlying pathology, respiratory, neuromuscular, immunodeficient or former premature of less of 34 weeks of amenorrhoea and less than 3 months of corrected age.
* child having set within 6 hours preceding the inclusion a treatment by bronchodilatateurs or corticoids by systematic or inhaled way.
28 Days
18 Months
ALL
No
Sponsors
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Assistance Publique Hopitaux De Marseille
OTHER
Responsible Party
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Principal Investigators
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BERNARD BELAIGUES
Role: STUDY_DIRECTOR
Assistance Publique hôpitaux de Marseille
Locations
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Assistance Publique Hopitaux de Marseille
Marseille, , France
Countries
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Other Identifiers
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2010-24
Identifier Type: OTHER
Identifier Source: secondary_id
2010-A01237-32
Identifier Type: -
Identifier Source: org_study_id