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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

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ClinicalTrials.gov Identifier: NCT01295398
Recruitment Status : Unknown
Verified March 2011 by Assistance Publique Hopitaux De Marseille.
Recruitment status was:  Active, not recruiting
First Posted : February 14, 2011
Last Update Posted : August 29, 2014
Sponsor:
Information provided by (Responsible Party):
Assistance Publique Hopitaux De Marseille

Brief Summary:
The aim of the investigators study is to compare in children aged less than 18 months and hospitalized for an acute viral bronchiolitis the efficacy of the HS 3% (Mucoclear®, sterile ampoules of 4 ml) nebulised with a conventional jet-nebulizer (particles diameter of 4-5 µm), or with a jet-nebulizer adapted for infants (particles diameter of 2-2.5 µm), or with a mesh-nebulizer adapted for infants (particles diameter of 2-2.5 µm).

Condition or disease Intervention/treatment Phase
Acute Viral Bronchiolitis Device: nebulisations Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 168 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: 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
Study Start Date : December 2010
Actual Primary Completion Date : May 2014
Estimated Study Completion Date : November 2014

Arm Intervention/treatment
conventional jet-nebulizer
(particles diameter of 4-5 µm)
Device: nebulisations
Experimental: a jet-nebulizer adapted for infants
(particles diameter of 2-2.5 µm),
Device: nebulisations
Experimental: a mesh-nebulizer adapted for infants
(particles diameter of 2-2.5 µm).
Device: nebulisations



Primary Outcome Measures :
  1. the improvement of the clinical score of severity at the 48th hour between the 3 groups of children [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. the number of children requiring oxygen [ Time Frame: 12 months ]
  2. tolerance of the nebulisations [ Time Frame: 12 months ]
  3. the number of complications. [ Time Frame: 12 months ]
  4. the number of parenteral nutrition [ Time Frame: 12 months ]


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Ages Eligible for Study:   up to 18 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Infant of less than 18 months old
  • 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:

  • Refusal of the parents to participate in the study
  • 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.

Information from the National Library of Medicine

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): NCT01295398


Locations
France
Assistance Publique Hopitaux de Marseille
Marseille, France, 13354
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
Investigators
Study Director: BERNARD BELAIGUES Assistance Publique hôpitaux de Marseille

Responsible Party: Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier: NCT01295398     History of Changes
Other Study ID Numbers: 2010-A01237-32
2010-24 ( Other Identifier: AP HM )
First Posted: February 14, 2011    Key Record Dates
Last Update Posted: August 29, 2014
Last Verified: March 2011

Additional relevant MeSH terms:
Bronchiolitis
Bronchiolitis, Viral
Bronchitis
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections
Virus Diseases