An interventional study of Nebulized isotonic saline and Nasal irrigation with isotonic saline in Bronchiolitis, Respiratory Disease and Asthma in Children, sponsored by Slagelse Hospital. Not yet recruiting. Open to participants aged 1 Day to 12 Months. Per ClinicalTrials.gov, last updated 2023-06-15.
Sponsored by Slagelse Hospital · Not applicable, Interventional, and Supportive care
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:
The children are randomized after inclusion through computer randomization to one of the 3 arms in the study:
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).
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.
Sample size: By including 249 children in total (83 in each arm) the investigators can prove non-inferiority of nasal irrigation or nebulized saline relative to no saline with a non-inferiority limit of 12 hours admission, alpha 2.5% and a power of 80%. The investigators aim to include 300 children in total to account for dropouts.
Recruitment: Children will only be included if both parents provide informed consent.
Perspectives: This study may improve current practice for supportive treatment of children with bronchiolitis. If saline is found to be helpful, it may be implemented into global guidelines. If no effect of saline is found, physicians may stop spending resources and manpower on an ineffective and potentially unpleasant treatment. Second, if saline is effective, but nasal irrigation proves to be non-inferior to nebulization, it may also reduce the workload of nurses, and possibly duration of hospitalization, because the treatment can be delivered by the parents at home. Moreover, the parents are empowered to manage their child's illness themselves, potentially improving the experience of parents as well as the affected child.
289 studies on the registry are indexed under Bronchiolitis; 51 are open to participants now.
This study's planned enrollment of 300 is above the median of 100 across 195 interventional studies indexed under Bronchiolitis.
Browse Bronchiolitis studies →Slagelse Hospital is the lead sponsor of 21 studies on the registry; 6 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Children aged 0-12 months, whose parents give to participate, with symptoms of bronchiolitis including at least one of:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
5 ml of isotonic saline is administered through a nebulizer with a flow of 10 l oxygen/min
Other: Nebulized isotonic saline
0.5-2 ml isotonic saline in each nostril administered as nasal drops
Other: Nasal irrigation with isotonic saline
These children will not receive any treatment with isotonic saline, but superficial suctioning of nasal secretions as needed (as part of standard care).
The intervention will constitute nebulized isotonic saline.
The intervention will constitute isotonic saline administered as nasal drops.
Duration of hospitalization
In hours
Time frame: 0-7 days typically (max 14 days)
Number of participants needing respiratory support
The need for respiratory support with nasal continuous positive airway pressure or high-flow oxygen therapy.
Time frame: During admission (up to day 14)
Number of participants being readmitted after discharge
If readmitted to the hospital
Time frame: 30 days after discharge
Respiratory severity score
Respiratory Severity Score with Heart Rate (RSS-HR), scale from 0-12, higher score means worse outcome.
Time frame: During admission (up to day 14)
Number of participants needing oxygen therapy
Need for oxygen therapy
Time frame: During admission (up to day 14)
Number of participants needing transfer to ICU or SICU
Transfer to the intensive care unit or semi-intensive care unit
Time frame: During admission (up to day 14)
Health-related Quality of Life
Health-related Quality of Life questionnaire developed by Díez-Gandía et al. (PMID: 34488668) including 12 items. Item responses will be scored using the following algorithm (unweighted method): (1) Each response item will be assigned a value according to its gravity (1 = best level or 9 = worst level). (2) The sum of the scores will be standardized using the min-max normalization to a 0-1-point scale, with 1 indicating the best quality of life and 0 the worst.
Time frame: Up to one month after discharge
Fluid supplements
Requirement of fluid supplements either by nasogastric tube or intravenous
Time frame: During admission (up to day 14)
pCO2
Highest pCO2 measured
Time frame: During admission (up to day 14)
Number of participants needing to switch treatment
Clinician-initiated switch to the opposite treatment from the one they were randomized to
Time frame: During admission (up to day 14)
Number of participants with visible distress
Visible distress in the child during delivery of treatment
Time frame: During admission (up to day 14)
Parents satisfaction
Parents satisfaction with the given treatment, questionnaire developed by the investigators exploring satisfaction of 3 items on a scale from 1-10 (total score from 3-30) where higher score means better outcome.
Time frame: Up to one month after discharge
No study locations are listed for this record.
Plan to share: Yes — We have planned to share all IPD with other researchers upon request.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
Time frame: We have planned to share all IPD with other researchers upon request 5 years after publication.
Access criteria: Researchers who request access.
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.
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Slagelse Hospital