BronchiolitisNCT05902702
Isotonic Saline for Children With Bronchiolitis
A study testing Nebulized isotonic saline and Nasal irrigation with isotonic saline in people with Bronchiolitis and Respiratory Disease, run by Slagelse Hospital.
Trial 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… Read more about this study
- Who is it for?
- Ages 1 day to 12 months
- Conditions the study is for
- Bronchiolitis, Respiratory Disease, Asthma in Children
- What is being tested?
- Nebulized isotonic saline and Nasal irrigation with isotonic saline
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- Sep 2023to Sep 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 12 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Show all 9Show fewer
- Wheezing or crackles on auscultation
- O2 saturations below 92 %
- Difficulties feeding
Who cannot join
- 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 locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Maren J Rytter, MD, PhD contact
About this study
Official title: Isotonic Saline for Children With Bronchiolitis - a Randomized Controlled Non-inferiority 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.
Read more
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).
Read the 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.
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.
- Conditions
- Bronchiolitis, Respiratory Disease, Asthma in Children, Viral Infection, Acute Respiratory Infection
- Being tested
- Nebulized isotonic saline, Nasal irrigation with isotonic saline
- Keywords
- Nebulized saline, Nasal saline drops, Nasal saline irrigation, Respiratory severity score
- Medical subject headings
- Bronchiolitis, Respiration Disorders, Virus Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nebulized isotonic salineOther
The intervention will constitute nebulized isotonic saline.
Nasal irrigation with isotonic salineOther
The intervention will constitute isotonic saline administered as nasal drops.
| Study group | Role | What they receive |
|---|---|---|
| Nebulized isotonic saline | Experimental | 5 ml of isotonic saline is administered through a nebulizer with a flow of 10 l oxygen/min Receives: Other: Nebulized isotonic saline |
| Nasal irrigation with isotonic saline | Experimental | 0.5-2 ml isotonic saline in each nostril administered as nasal drops Receives: Other: Nasal irrigation with isotonic saline |
| No treatment with saline | No intervention | These children will not receive any treatment with isotonic saline, but superficial suctioning of nasal secretions as needed (as part of standard care). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of hospitalization
In hours
Measured: 0-7 days typically (max 14 days)
Secondary outcomes (11)
Number of participants needing respiratory support
The need for respiratory support with nasal continuous positive airway pressure or high-flow oxygen therapy.
Measured: During admission (up to day 14)
Number of participants being readmitted after discharge
If readmitted to the hospital
Measured: 30 days after discharge
Respiratory severity score
Respiratory Severity Score with Heart Rate (RSS-HR), scale from 0-12, higher score means worse outcome.
Measured: During admission (up to day 14)
Number of participants needing oxygen therapy
Need for oxygen therapy
Measured: 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
Measured: 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.
Measured: Up to one month after discharge
Fluid supplements
Requirement of fluid supplements either by nasogastric tube or intravenous
Measured: During admission (up to day 14)
pCO2
Highest pCO2 measured
Measured: 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
Measured: During admission (up to day 14)
Number of participants with visible distress
Visible distress in the child during delivery of treatment
Measured: 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.
Measured: Up to one month after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2023
- Study startSep 2023 (estimated)
- Primary completionSep 2024 (estimated)
- Study completionSep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for BronchiolitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- An investigator-initiated, multicenter, open label, three-arm randomized, controlled non-inferiority trial.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Slagelse Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Copenhagen University Hospital at Herlev, Zealand University Hospital, Copenhagen University Hospital, Hvidovre, Holbaek Sygehus, Nordsjaellands Hospital, Nykøbing Falster Hospital
- Responsible party
- Sponsor
- Investigators
- Ann-Marie M Schoos, MD, PhD, Principal investigator, Slagelse Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05902702
- Sponsor's protocol ID
- Bronchiolitis project
- Status last verified
- Jun 2023
- First submitted
- 31 May 2023
- Last updated
- 15 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We have planned to share all IPD with other researchers upon request.
Publications
Schmidt MN, Daugberg R, Nygaard U, Nielsen XC, Chawes B, Rytter MH, Schoos AM. Normal saline for children with bronchiolitis: study protocol for a randomised controlled non-inferiority trial. BMJ Paediatr Open. 2024 Jan 17;8(1):e002273. doi: 10.1136/bmjpo-2023-002273.
PubMed 38233083
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Isotonic Saline for Children With Bronchiolitis - a Randomized Controlled Non-inferiority Trial
- ClinicalTrials.gov ID
- NCT05902702
- Acronym / sponsor ID
- Bronchiolitis project
- Conditions
- Bronchiolitis, Respiratory Disease, Asthma in Children, Viral Infection, Acute Respiratory Infection
- Keywords
- Nebulized saline, Nasal saline drops, Nasal saline irrigation, Respiratory severity score
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Slagelse HospitalUniversity, hospital or other
- Collaborators
- Copenhagen University Hospital at Herlev, Zealand University Hospital, Copenhagen University Hospital, Hvidovre, Holbaek Sygehus, Nordsjaellands Hospital, Nykøbing Falster Hospital
- Study start
- Sep 2023 (estimated)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Sep 2029 (estimated)
- First posted
- 15 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- An investigator-initiated, multicenter, open label, three-arm randomized, controlled non-inferiority trial.
| Arm | Type | Receives |
|---|---|---|
| Nebulized isotonic saline | Experimental | Other: Nebulized isotonic saline5 ml of isotonic saline is administered through a nebulizer with a flow of 10 l oxygen/min |
| Nasal irrigation with isotonic saline | Experimental | Other: Nasal irrigation with isotonic saline0.5-2 ml isotonic saline in each nostril administered as nasal drops |
| No treatment with saline | No intervention | –These children will not receive any treatment with isotonic saline, but superficial suctioning of nasal secretions as needed (as part of standard care). |
Who may qualify
- Ages
- 1 day to 12 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- Children aged 0-12 months, whose parents give informed consent to participate, with symptoms of bronchiolitis including at least one of:
Key exclusion criteria (2 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nebulized isotonic salineThe intervention will constitute nebulized isotonic saline. | Other | Nebulized isotonic saline |
| Nasal irrigation with isotonic salineThe intervention will constitute isotonic saline administered as nasal drops. | Other | Nasal irrigation with isotonic saline |
Primary outcome
Duration of hospitalization
Time frame: 0-7 days typically (max 14 days)
In hours
11 secondary outcomes
Number of participants needing respiratory support
Time frame: During admission (up to day 14)
Number of participants being readmitted after discharge
Time frame: 30 days after discharge
Respiratory severity score
Time frame: During admission (up to day 14)
Number of participants needing oxygen therapy
Time frame: During admission (up to day 14)
Number of participants needing transfer to ICU or SICU
Time frame: During admission (up to day 14)
Health-related Quality of Life
Time frame: Up to one month after discharge
Fluid supplements
Time frame: During admission (up to day 14)
pCO2
Time frame: During admission (up to day 14)
Number of participants needing to switch treatment
Time frame: During admission (up to day 14)
Number of participants with visible distress
Time frame: During admission (up to day 14)
Parents satisfaction
Time frame: Up to one month after discharge
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2023.
- Derived from this study: PubMed 38233083Schmidt MN, Daugberg R, Nygaard U, Nielsen XC, Chawes B, Rytter MH, Schoos AM. Normal saline for children with bronchiolitis: study protocol for a randomised controlled non-inferiority trial. BMJ Paediatr Open. 2024 Jan 17;8(1):e002273. doi: 10.1136/bmjpo-2023-002273.
- Individual participant dataSharing planned: Yes. We have planned to share all IPD with other researchers upon request.
Related trials for Bronchiolitis
RecruitingPhase 3
A Study to Evaluate Axatilimab and Corticosteroids as Initial Treatment for Chronic Graft-Versus-Host Disease
Chronic Graft-versus-host-disease
Not yet recruiting
Evaluating and Promoting Resilience in Adolescents With Tourette Syndrome
Tourette Syndrome, Tic Disorders
Recruiting
RSV Burden in Outpatient and Hospital Settings
RSV Infection, Children, Only
RecruitingPhase 1
Ex Vivo-Expanded Regulatory T Cells Plus Low-Dose Interleukin-2 for Steroid-Refractory Chronic GVHD
Graft Versus Host Disease (cGvHD)
Not yet recruiting
Short-Term Enteral Nutrition for Infants With Bronchiolitis in Pediatric Emergency Departments
Bronchiolitis, Clinical Phenotype
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Maren J Rytter, MD, PhD contact
Ann-Marie M Schoos, MD, PhD principal investigator
Slagelse Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Nebulized isotonic saline and Nasal irrigation with isotonic saline in people with Bronchiolitis and Respiratory Disease, run by Slagelse Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ann-Marie M Schoos, MD, PhD (+45 20681250, annms@regionsjaelland.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of hospitalization (time frame: 0-7 days typically (max 14 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05902702, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2023.