Clinical Trial: 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Study Status: Withdrawn
Recruit Status: Unknown status
Study Type: Interventional

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

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).

Detailed Summary:
Sponsor: Assistance Publique Hopitaux De Marseille

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

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • the number of children requiring oxygen [ Time Frame: 12 months ]
  • tolerance of the nebulisations [ Time Frame: 12 months ]
  • the number of complications. [ Time Frame: 12 months ]
  • the number of parenteral nutrition [ Time Frame: 12 months ]


Original Secondary Outcome: Same as current

Information By: Assistance Publique Hopitaux De Marseille

Dates:
Date Received: February 9, 2011
Date Started: December 2010
Date Completion: November 2014
Last Updated: August 28, 2014
Last Verified: March 2011