Clinical trial NCT01812525: Moderate to Severe Bronchiolitis: Standard Therapy Versus Therapy With NaCl 3% Inhalations
Official title: Moderate to Severe Bronchiolitis: Standard Therapy Versus Therapy With NaCl 3%
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Moderate to Severe Bronchiolitis
Keywords: Bronchiolitis
Moderate to Severe
Hypertonic saline
NaCl 3% inhalations
Standard therapy
Wang score
in-patients
Lead sponsor: Hôpital de L'Enfance
Sponsor class: OTHER
Collaborators: name: Swiss Foundation for the Health of Children and Adolescents
First posted: 2013-03-18
Enrollment: 120
Sex: ALL
Minimum age (years): 6
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Our study will investigate inhalation therapy of NaCl 3% compared to standard therapy with no inhalation in the treatment of moderate to severe bronchiolitis. The impact on length of hospital stay will be analyzed.

Detailed description: Acute viral bronchiolitis is the most common lower respiratory tract infection in the first year of life and leads to a large number of hospital admissions. The only recommended treatment is supportive. However many different types of drug inhalations have been studied but their efficacy remains controversial.

Our study will compare recommended supportive therapy to supportive therapy combined to hypertonic saline (NaCl 3%) inhalations in the treatment of moderate to severe bronchiolitis. This will be the first study to use a true control group with no inhalation.

Eligibility criteria: Inclusion Criteria:

* children between ages 6 weeks to 24 months
* first episode of wheezing
* diagnosis of moderate to severe bronchiolitis: The patients are ranked as moderately to severely ill according to the Wang clinical severity score

Exclusion Criteria:

* Children with mild bronchiolitis (Wang score \< 5)
* Children with pre-existent cardiac disease
* Children with clinically significant chronic respiratory disease
* Immunocompromised children
* Children with a gestational age at birth less than 34 weeks
* Children who received immunoprophylaxis therapy (i.e RSV immune globulin therapy)
* Children who received corticosteroid in any form in the preceding 2 weeks before presentation
* Children who received bronchodilators within 24 hours before presentation
* Children with critical illness at presentation requiring immediate admission to intensive care unit

Primary outcomes:
measure: length of hospital stay
timeFrame: 2 years
Secondary outcomes:
measure: transfer rate to ICU
timeFrame: 2 years
measure: readmission rate in the next 7 days following discharge
timeFrame: 2 years
measure: Wang clinical severity score evolution
timeFrame: 2 years
measure: adverse events
timeFrame: 2 years
measure: Patients' ability to feed
timeFrame: 2 years
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: Hôpital de l'Enfance
state: Vaud
Study officials:
affiliation: Hôpital de l'Enfance, Lausanne, Switzerland
name: Jean-Yves Pauchard
role: STUDY_DIRECTOR
References:
citation: Jaquet-Pilloud R, Verga ME, Russo M, Gehri M, Pauchard JY. Nebulised hypertonic saline in moderate-to-severe bronchiolitis: a randomised clinical trial. Arch Dis Child. 2020 Mar;105(3):236-240. doi: 10.1136/archdischild-2019-317160. Epub 2019 Sep 5.