This trial is active, not recruiting.

Condition acute viral bronchiolitis
Treatment nebulisations
Sponsor Assistance Publique Hopitaux De Marseille
Start date December 2010
End date May 2014
Trial size 168 participants
Trial identifier NCT01295398, 2010-24, 2010-A01237-32


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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose prevention
(particles diameter of 4-5 µm)
(particles diameter of 2-2.5 µm),
(particles diameter of 2-2.5 µm).

Primary Outcomes

the improvement of the clinical score of severity at the 48th hour between the 3 groups of children
time frame: 12 months

Secondary Outcomes

the number of children requiring oxygen
time frame: 12 months
tolerance of the nebulisations
time frame: 12 months
the number of complications.
time frame: 12 months
the number of parenteral nutrition
time frame: 12 months

Eligibility Criteria

Male or female participants up to 18 months old.

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.

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in August 2014.
Information provided to ClinicalTrials.gov by Assistance Publique Hopitaux De Marseille.