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

Acute Viral Bronchiolitis Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01295398
• Other study ID #: 2010-A01237-32
• Secondary ID: 2010-24
• Status: Active, not recruiting
• Phase: N/A
• First received: February 9, 2011
• Last updated: August 28, 2014
• Start date: December 2010
• Est. completion date: November 2014

Study information

• Verified date: March 2011
• Source: Assistance Publique Hopitaux De Marseille
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 168
• Est. completion date: November 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 18 Months

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Acute Viral Bronchiolitis
• Bronchiolitis
• Bronchiolitis, Viral

Intervention

Device:
• nebulisations

Locations

Country	Name	City	State
France	Assistance Publique Hopitaux de Marseille	Marseille

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the improvement of the clinical score of severity at the 48th hour between the 3 groups of children		12 months	Yes
Secondary	the number of children requiring oxygen		12 months	Yes
Secondary	tolerance of the nebulisations		12 months	Yes
Secondary	the number of complications.		12 months	Yes
Secondary	the number of parenteral nutrition		12 months	No