Moderate to Severe Bronchiolitis: Standard Therapy Versus Therapy With NaCl 3% Inhalations

Moderate to Severe Bronchiolitis: Standard Therapy Versus Therapy With NaCl 3%

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.

Study Overview

• Status: Completed
• Conditions: Moderate to Severe Bronchiolitis
• Intervention / Treatment: Drug: NaCl 3%; Other: Standard therapy

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.

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Phase 3

Contacts and Locations

Study Locations

• Switzerland
  • Vaud
    • Lausanne, Vaud, Switzerland, 1000
      • Hôpital de l'Enfance

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 1 year (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: NaCl 3% inhalations + standard therapy; In this group, patients receive NaCl 3% inhalations ( 4ml QID) together with standard therapy. Standard therapy includes suctioning nasal secretions, water-electrolyte balance maintenance and oxygen supplementation when needed.	Drug: NaCl 3%; NaCl 3%: 4ml QID; Other Names: Mucoclear 3%; Other: Standard therapy; Standard therapy includes suctioning nasal secretions, water-electrolyte balance maintenance and oxygen supplementation when needed
Placebo Comparator: Standard therapy; Standard therapy includes suctioning nasal secretions, water-electrolyte balance maintenance and oxygen supplementation when needed	Other: Standard therapy; Standard therapy includes suctioning nasal secretions, water-electrolyte balance maintenance and oxygen supplementation when needed

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
length of hospital stay	The length of stay is defined as the time between study entry and the time at which the child reach protocol-defined discharge criteria as measured by the physician in charge.	2 years

Secondary Outcome Measures

Outcome Measure	Time Frame
transfer rate to ICU	2 years
readmission rate in the next 7 days following discharge	2 years
Wang clinical severity score evolution	2 years
adverse events	2 years
Patients' ability to feed	2 years

Collaborators and Investigators

• Sponsor: Raphaelle Jaquet-Pilloud
• Collaborators: Swiss Foundation for the Health of Children and Adolescents
• Investigators: Study Director: Jean-Yves Pauchard, Hôpital de l'Enfance, Lausanne, Switzerland

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: March 1, 2013
• Primary Completion (Actual): April 1, 2016
• Study Completion (Actual): April 1, 2016

Study Registration Dates

• First Submitted: March 14, 2013
• First Submitted That Met QC Criteria: March 14, 2013
• First Posted (Estimate): March 18, 2013

Study Record Updates

• Last Update Posted (Estimate): August 19, 2016
• Last Update Submitted That Met QC Criteria: August 17, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Keywords: Standard therapy; Moderate to Severe; Hypertonic saline; Bronchiolitis; NaCl 3% inhalations; Wang score; in-patients
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Bronchitis; Bronchiolitis
• Other Study ID Numbers: 453/12