Isotonic Saline for Children With Bronchiolitis - a Randomized Controlled Non-inferiority Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 300
- Primary Endpoint
- Duration of hospitalization
Study Overview
Brief Summary
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:
- Nebulized isotonic saline
- Nasal irrigation with isotonic saline
- 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).
Detailed Description
Design: An investigator-initiated, multicenter, open label, three-arm randomized, controlled non-inferiority trial.
Study sites: Seven pediatric departments in eastern Denmark (Slagelse Hospital, Holbæk Hospital, Zealand University Hospital Roskilde, Copenhagen University Hospital Hvidovre, Copenhagen University Hospital Herlev, Nordsjaellands Hospital, and Nykoebing Falster Hospital).
Participants: Children aged 0-12 months admitted to a pediatric department or emergency department in eastern Denmark with bronchiolitis, whose parents provide informed consent for participation.
Randomization: Participating children are randomized 1:1:1 through computer randomization to either nebulized isotonic saline, nasal irrigation with isotonic saline or no isotonic saline therapy at all. Participating children will have a nasal sample collected and tested for a panel of viral pathogens. Excess material (1 ml nasal lining fluid) from upper airway respiratory samples will be stored in a research biobank until 31.12.2030 and used for sub-phenotyping of bronchiolitis and for developing personalized treatment and prediction of later asthma by means of host transcriptomics and metabolomics, 16S sequencing of the airway microbiome and meta-transcriptomics.
All other treatment is given according to standard of care guidelines.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Single (Outcomes Assessor)
Masking Description
Outcome assessor will receive anonymized data for analysis.
Eligibility Criteria
- Ages
- 1 Day to 12 Months (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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)
- •Cyanosis or apnea
- •Wheezing or crackles on auscultation
- •O2 saturations below 92 %
- •Difficulties feeding
Exclusion Criteria
- •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).
Outcomes
Primary Outcomes
Duration of hospitalization
Time Frame: 0-7 days typically (max 14 days)
In hours
Secondary Outcomes
- Respiratory severity score(During admission (up to day 14))
- Fluid supplements(During admission (up to day 14))
- Number of participants needing respiratory support(During admission (up to day 14))
- Number of participants needing oxygen therapy(During admission (up to day 14))
- Number of participants needing transfer to ICU or SICU(During admission (up to day 14))
- Number of participants being readmitted after discharge(30 days after discharge)
- Health-related Quality of Life(Up to one month after discharge)
- pCO2(During admission (up to day 14))
- Number of participants with visible distress(During admission (up to day 14))
- Parents satisfaction(Up to one month after discharge)
- Number of participants needing to switch treatment(During admission (up to day 14))