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Completed

NCT Number: NCT01812525

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

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.

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Key information

Age range

6 week–24 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hôpital de l'Enfance

Lausanne, Canton of Vaud, 1000, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

NaCl 3%

Drug

NaCl 3%: 4ml QID

Other names: Mucoclear 3%

Standard therapy

Other

Standard therapy includes suctioning nasal secretions, water-electrolyte balance maintenance and oxygen supplementation when needed

Primary outcomes

  1. 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 outcomes

  1. transfer rate to ICU

    Time frame: 2 years

  2. readmission rate in the next 7 days following discharge

    Time frame: 2 years

  3. Wang clinical severity score evolution

    Time frame: 2 years

  4. adverse events

    Time frame: 2 years

  5. Patients' ability to feed

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

Raphaelle Jaquet-Pilloud

Other

Collaborators

  • Swiss Foundation for the Health of Children and Adolescents

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Mar 18, 2013
Registry last updated
Aug 19, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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