About this trial
The goal of this randomized clinical trial is to investigate the optimal supportive treatment of bronchiolitis in infants from 0-12 months of age. The main question\[s\] it aims to answer are:
* To investigate whether isotonic saline should be used as supportive treatment for children with bronchiolitis, and if so, identify the optimal route of administration. The primary outcome is duration of hospitalization. * To investigate the current epidemiology of the viral pathogens causing bronchitis in children in Denmark, and to assess whether children infected with specific pathogens might benefit from treatment with isotonic saline.
The children are randomized after inclusion through computer randomization to one of the 3 arms in the study:
1. Nebulized isotonic saline 2. Nasal irrigation with isotonic saline 3. No treatment with saline
The investigators will compare treatment with saline (both methods) with no treatment, and the investigators will also compare the two methods of delivery of saline (nebulized vs. nasal irrigation).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Runny nose
Dry and persistent cough
Labored breathing (tachypnea, retractions, nasal flaring)
Grunting
Disqualifiers
Children with cystic fibrosis or other serious congenital lung diseases
Children in whom treatment with short-acting beta-2 agonist is initiated (as this is delivered in nebulized isotonic saline).
Trial design
Parallel
Treatments tested in this trial
Nebulized isotonic saline
Other interventionThe intervention will constitute nebulized isotonic saline.
Nasal irrigation with isotonic saline
Other interventionThe intervention will constitute isotonic saline administered as nasal drops.
Treatment groups
Trial outcomes
Primary outcomes
Duration of hospitalization
In hours
Secondary outcomes
Number of participants needing respiratory support
The need for respiratory support with nasal continuous positive airway pressure or high-flow oxygen therapy.
Number of participants being readmitted after discharge
If readmitted to the hospital
Respiratory severity score
Respiratory Severity Score with Heart Rate (RSS-HR), scale from 0-12, higher score means worse outcome.
Number of participants needing oxygen therapy
Need for oxygen therapy
Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Slagelse Hospital
Lead sponsor
Copenhagen University Hospital at Herlev
Collaborator
Zealand University Hospital
Collaborator
Copenhagen University Hospital, Hvidovre
Collaborator
Holbaek Sygehus
Collaborator
Nordsjaellands Hospital
Collaborator
Nykøbing Falster Hospital
Collaborator
This trial is not recruiting at the moment. You can still explore other options: