NCT05902702Not yet recruiting
Isotonic Saline for Children With Bronchiolitis
Isotonic Saline for Children With Bronchiolitis - a Randomized Controlled Non-inferiority Trial
Source: ClinicalTrials.gov · Last updated 15 Jun 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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).
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 300 (estimated)
- First submitted
- 31 May 2023
- Start date
- Sept 2023
- Primary completion date
- Sept 2024
- Lead sponsor
- Slagelse Hospital
- Diseases
- Asthma
- NCT number
- NCT05902702
What you commit to
- Study type: Interventional
- Planned participants: 300
- From Sept 2023 to the primary completion date, Sept 2024
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Children in whom treatment with short-acting beta-2 agonist is initiated (as this is delivered in nebulized isotonic saline).
Other illness
- Children with cystic fibrosis or other serious congenital lung diseases
Who the study is looking for
- Children aged 0-12 months, whose parents give informed consent to participate, with symptoms of bronchiolitis including at least one of:
- Runny nose
- Dry and persistent cough
- Labored breathing (tachypnea, retractions, nasal flaring)
- Grunting
- Cyanosis or apnea
- Wheezing or crackles on auscultation
- O2 saturations below 92 %
- Difficulties feeding
Age in the registry: 1 day to 12 months · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.