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

August 28, 2014 updated by: Assistance Publique Hopitaux De Marseille
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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

168

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Marseille, France, 13354
        • Assistance Publique Hopitaux de Marseille

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 weeks to 1 year (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
the number of children requiring oxygen
Time Frame: 12 months
12 months
tolerance of the nebulisations
Time Frame: 12 months
12 months
the number of complications.
Time Frame: 12 months
12 months
the number of parenteral nutrition
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique Hopitaux De Marseille

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2010

Primary Completion (ACTUAL)

May 1, 2014

Study Completion (ANTICIPATED)

November 1, 2014

Study Registration Dates

First Submitted

February 9, 2011

First Submitted That Met QC Criteria

February 11, 2011

First Posted (ESTIMATE)

February 14, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

August 29, 2014

Last Update Submitted That Met QC Criteria

August 28, 2014

Last Verified

March 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2010-A01237-32
  • 2010-24 (OTHER: AP HM)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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