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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01812525
First Posted: March 18, 2013
Last Update Posted: August 19, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Swiss Foundation for the Health of Children and Adolescents
Information provided by (Responsible Party):
Raphaelle Jaquet-Pilloud, Hôpital de L'Enfance
  Purpose
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.

Condition Intervention Phase
Moderate to Severe Bronchiolitis Drug: NaCl 3% Other: Standard therapy Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Moderate to Severe Bronchiolitis: Standard Therapy Versus Therapy With NaCl 3%

Further study details as provided by Raphaelle Jaquet-Pilloud, Hôpital de L'Enfance:

Primary Outcome Measures:
  • length of hospital stay [ Time Frame: 2 years ]
    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.


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

Enrollment: 120
Study Start Date: March 2013
Study Completion Date: April 2016
Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Weeks to 24 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01812525


Locations
Switzerland
Hôpital de l'Enfance
Lausanne, Vaud, Switzerland, 1000
Sponsors and Collaborators
Raphaelle Jaquet-Pilloud
Swiss Foundation for the Health of Children and Adolescents
Investigators
Study Director: Jean-Yves Pauchard Hôpital de l'Enfance, Lausanne, Switzerland
  More Information

Responsible Party: Raphaelle Jaquet-Pilloud, Jean-Yves Pauchard, MD, Hôpital de L'Enfance
ClinicalTrials.gov Identifier: NCT01812525     History of Changes
Other Study ID Numbers: 453/12
First Submitted: March 14, 2013
First Posted: March 18, 2013
Last Update Posted: August 19, 2016
Last Verified: August 2016

Keywords provided by Raphaelle Jaquet-Pilloud, Hôpital de L'Enfance:
Bronchiolitis
Moderate to Severe
Hypertonic saline
NaCl 3% inhalations
Standard therapy
Wang score
in-patients

Additional relevant MeSH terms:
Bronchiolitis
Bronchitis
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections