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

NCT01295398 | Unknown

• 2 other identifiers: 2010-A01237-322010-24
• Study Type: interventional
• Target: 168
• Locations: 1 country
• Sites: 1

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).

Conditions

Acute Viral Bronchiolitis

Outcome Measures

Primary Outcomes (1)

• the improvement of the clinical score of severity at the 48th hour between the 3 groups of children

  12 months

Secondary Outcomes (4)

• the number of children requiring oxygen

  12 months

• tolerance of the nebulisations

  12 months

• the number of complications.

  12 months

• the number of parenteral nutrition

  12 months

Study Arms (3)

conventional jet-nebulizer

OTHER

(particles diameter of 4-5 µm)

Device: nebulisations

a jet-nebulizer adapted for infants

EXPERIMENTAL

(particles diameter of 2-2.5 µm),

Device: nebulisations

a mesh-nebulizer adapted for infants

EXPERIMENTAL

(particles diameter of 2-2.5 µm).

Device: nebulisations

Interventions

nebulisations DEVICE

a jet-nebulizer adapted for infants; a mesh-nebulizer adapted for infants; conventional jet-nebulizer

Eligibility Criteria

• Age: 28 Days - 18 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead

Study Sites (1)

Assistance Publique Hopitaux de Marseille

Marseille, 13354, France

Location

Study Officials

• BERNARD BELAIGUES

  Assistance Publique hôpitaux de Marseille

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2011
• First Posted: February 14, 2011
• Study Start: December 1, 2010
• Primary Completion: May 1, 2014
• Study Completion: November 1, 2014
• Last Updated: August 29, 2014

Record last verified: 2011-03

Locations

FR (1)