Clinical trial NCT01295398: 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
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acute Viral Bronchiolitis
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2011-02-14
Enrollment: 168
Sex: ALL
Minimum age (years): 28
Maximum age (years): 18
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).


Eligibility 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.

Primary outcomes:
measure: the improvement of the clinical score of severity at the 48th hour between the 3 groups of children
timeFrame: 12 months
Secondary outcomes:
measure: the number of children requiring oxygen
timeFrame: 12 months
measure: tolerance of the nebulisations
timeFrame: 12 months
measure: the number of complications.
timeFrame: 12 months
measure: the number of parenteral nutrition
timeFrame: 12 months
Other outcomes:
Locations:
city: Marseille
country: France
facility: Assistance Publique Hopitaux de Marseille
Study officials:
affiliation: Assistance Publique hôpitaux de Marseille
name: BERNARD BELAIGUES
role: STUDY_DIRECTOR
References: