Efficacy of 3% Hypertonic Saline in Acute Viral Bronchiolitis
Condition: Acute Viral Bronchiolitis
MeSH terms: Bronchiolitis; Bronchiolitis, Viral
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine whether nebulized hypertonic saline solution
      reduces the admission rate 48 hours after initial treatment in the emergency department, when
      compared to normal saline solution (control).
    

Detailed description: 
      Acute viral bronchiolitis remains a significant cause of hospitalization and to date, no
      treatment reduce the rate of hospitalization. The only accepted treatment for bronchiolitis
      is nasal cleaning, hydration and for hospitalized hypoxemic infants, oxygen administration.

      Several studies shown that nebulization of hypertonic saline solution reduce length of stay
      in hospital for hospitalized infant but effect on rate of hospitalization remains unclear.

      The investigators propose a randomized double blind multicenter clinical trial on infants 6
      weeks to 12 months old with moderate or severe bronchiolitis, in 21 emergency departments of
      hospitals situated France, during 2 winter seasons.

      The investigators hypothesize that infants with bronchiolitis treated with nebulized
      hypertonic 3% saline solution would have less risk of being hospitalized. Our principal
      objective is to determine if nebulized 3% hypertonic saline solution reduces admission rate
      24 hours after treatment compared to placebo.

      Secondary objectives are to compare between groups intensity of respiratory symptoms measured
      by RDAI clinical score, duration of symptoms, length of hospital stay for hospitalized
      infants, adverse effects and health care utilization.

      Patients presenting to the Emergency Department with a diagnosis of moderately severe
      bronchiolitis will be approached for entry into the study. After the initial routine
      assessment, informed consent will be obtained and the infant will be randomized to receive
      treatment in a double-blinded fashion 4 ml of nebulized study solution either 3% hypertonic
      saline (HS, study group) or 0.9% saline (NS, control group) every 20 minutes for a total of 2
      doses. After an observation period of 20 minutes following the last dose, the infant will be
      reassessed by the attending physician in the ER for disposition (admit, discharge home). All
      subsequent therapy, if needed, will be at the sole discretion of the attending physician. The
      family of each recruited subject will be contacted by phone 2, 7, 14 and 28 days later to
      assess resolution of symptoms.

      Clinical response to the above treatment will also be determined independently by the study
      physician utilizing a standardized respiratory scoring system, the Respiratory Distress
      Assessment Instrument (RDAI), at study entry and after each nebulization. The primary outcome
      measure is the rate of admission to hospital between the study and control groups 24 hours
      after inclusion. Secondary outcomes measure will involve the assessment of change in the RDAI
      between study entry and post-treatment, adverse effects, length of stay for hospitalized
      infant and health care utilization.
    

Intervention name(s): 3% Saline; 0.9% Normal Saline
Intervention type(s): Drug; Drug
Intervention description(s): Two 4 mL nebulization of 3% saline with 20 minutes interval; Two 4 mL nebulization of 0.9% normal saline with 20 minutes interval
Other intervention name(s): 3% Hypertonic Saline Solution for Inhalation (Mucoclear 3%); 0.9% Saline Solution for Inhalation
Intervention MeSH terms: Pharmaceutical Solutions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Keywords provided by ASSISTANCE PUBLIQUE HOPITAUX DE PARIS:; Acute Viral bronchiolitis; Hypertonic saline; Hospitalization; Infants; Hospital admissions; Additional relevant MeSH terms:; Bronchiolitis; Bronchiolitis, Viral; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Respiratory Tract Infections; Virus Diseases