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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by Assistance Publique Hopitaux De Marseille.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier:
NCT01295398
First received: February 9, 2011
Last updated: March 31, 2011
Last verified: March 2011
  Purpose

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 Intervention
Acute Viral Bronchiolitis
Device: nebulisations

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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

Further study details as provided by Assistance Publique Hopitaux De Marseille:

Primary Outcome Measures:
  • the improvement of the clinical score of severity at the 48th hour between the 3 groups of children [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • the number of children requiring oxygen [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • tolerance of the nebulisations [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • the number of complications. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • the number of parenteral nutrition [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 168
Study Start Date: December 2010
Estimated Study Completion Date: September 2012
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   up to 18 Months
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01295398

Contacts
Contact: jean-christophe DUBUS 0491386726 jdubus@ap-hm.fr

Locations
France
Assistance Publique Hopitaux de Marseille Recruiting
Marseille, France, 13354
Contact: jean christophe DUBUS       jdubus@ap-hm.fr   
Principal Investigator: jean christophe DUBUS         
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
Investigators
Study Director: BERNARD BELAIGUES Assistance Publique hôpitaux de Marseille
  More Information

No publications provided

Responsible Party: direction de la recherche, ASSISTANCE PUBLIQUE HOPITAUX DE MARSEILLE
ClinicalTrials.gov Identifier: NCT01295398     History of Changes
Other Study ID Numbers: 2010-A01237-32, 2010-24
Study First Received: February 9, 2011
Last Updated: March 31, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

ClinicalTrials.gov processed this record on July 31, 2014