BronchiolitisNCT06069336
Nebulised 3% Hypertonic Saline Versus 0.9% Saline for Treating Patients Hospitalized With Acute Bronchiolitis
A study testing Hypertonic saline and Normal saline in people with Bronchiolitis, run by Szpital im. Św. Jadwigi Śląskiej at 3 sites in Poland.
Trial summary
Bronchiolitis is an acute viral infection of the lower respiratory tract. It is most commonly caused by respiratory syncytial virus (RSV). Only supportive therapy, including suctioning nasal secretions, water-electrolyte balance maintenance, and oxygen supplementation when needed, is recommended. Read more about this study
- Who is it for?
- Ages 5 weeks to 24 months
- Conditions the study is for
- Bronchiolitis
- What is being tested?
- Hypertonic saline and Normal saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 3 sitesPoland
- Study dates
- 1 Nov 2023to 30 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 5 weeks to 24 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children admitted to the hospital with the clinical diagnosis of acute bronchiolitis, which is defined as an apparent viral respiratory tract infection associated with airway obstruction manifested by at least one of following symptoms:
- Tachypnoea (WHO definition).
- Increased respiratory effort manifested as follows:
- Nasal flaring;
- Grunting;
- Use of accessory muscles;
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- Intercostal and/or subcostal chest wall retractions;
- Apnoe.
- Crackles and/or wheezing.
- Aged 5 weeks - 24 months old.
- A caregiver must provide written informed consent.
Who cannot join
- Infants hospitalised with severe bronchiolitis (requiring mechanical ventilation or intensive care, or oxygen saturation < 85% on room air).
- History of prematurity (gestational age <34 weeks).
- Diagnosis of a clinically significant chronic disease (cardiac, respiratory, neuromuscular, or metabolic).
- Immunodeficiency.
- Gastro-oesophageal reflux.
- Diagnosis or suspicion of asthma.
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- Inhaling a nebulised 3% hypertonic saline solution within 12 hours before enrolment.
- Inhaling bronchodilators within 24 hours before enrolment.
- Inhaling steroids within 24 hours before enrolment.
- Systemic steroid therapy in the preceding 2 weeks.
Trial locations and contacts
3 sites in 1 country.
Poland3 sites
Szpiatal im.Świętej Jadwigi Śląskiej
Trzebnica, 55-100
Specjalistyczny Szpital im. Alfreda Sokołowskiego w Wałbrzychu
Wałbrzych, 58-309
Dziecięcy Szpital Kliniczny im. Polikarpa Brudzińskiego w Warszawie
Warsaw, 02-091
About this study
Official title: Nebulised 3% Hypertonic Saline Versus 0.9% Saline for Treating Patients Hospitalized With Acute Bronchiolitis: Protocol of a Randomized, Double-blind, Multicentre Trial
Bronchiolitis is an acute viral infection of the lower respiratory tract. It is most commonly caused by respiratory syncytial virus (RSV). Only supportive therapy, including suctioning nasal secretions, water-electrolyte balance maintenance, and oxygen supplementation when needed, is recommended. The inhalation of 3% hypertonic saline is not recommended in bronchiolitis management. However, a recently published meta-analysis revealed that the inhalation of hypertonic saline can reduce the risk of hospitalisation for outpatients with bronchiolitis, while resulting in a shorter length of hospital stay and reduced severity of respiratory distress for inpatients, although the evidence is of low certainty.
The aim of the study is to assess the efficacy of nebulised hypertonic saline for the treatment of children hospitalised with bronchiolitis.
- Conditions
- Bronchiolitis
- Being tested
- Hypertonic saline, Normal saline
- Keywords
- hypertonic saline, infants, RCT
- Medical subject headings
- Bronchiolitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypertonic salineDrug
Nebulised 3% hypertonic saline (NEBU-dose hypertonic). Nebulisation will be performed by trained study nurses or by parents under the supervision of a nurse
Normal salineDrug
0,9% normal saline (NEBU-dose isotonic). Nebulisation will be performed by trained study nurses or by parents under the supervision of a nurse
| Study group | Role | What they receive |
|---|---|---|
| Hypertonic saline | Active comparator | 3% hypertonic saline (NEBU-dose hypertonic). The treatment will be delivered through nebulisation using oxygen with 5 litres of O2 flow, or through a compressed air-driven jet nebuliser, every 6 hours for three times daily with a night break, until discharge. Receives: Drug: Hypertonic saline |
| Normal saline | Placebo comparator | 0,9% normal saline (NEBU-dose isotonic).The treatment will be delivered through nebulisation using oxygen with 5 litres of O2 flow, or through a compressed air-driven jet nebuliser, every 6 hours for three times daily with a night break, until discharge. Receives: Drug: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of hospital stay (LOS).
Measured: From admission to hospital discharge
Secondary outcomes (7)
Number of participants requiring oxygen supplementation
Measured: During the intervention
Duration of oxygen supplementation
among those requiring oxygen
Measured: During the intervention
The time until the infant will be assessed as being 'fit for discharge'
which is defined as the point at which the infant will be feeding adequately (taking >75% of their usual intake based on parents' assessment) and will have a saturation of at least 92% for 6 h on room air, while the axillary body temperature will remain - among those requiring oxygen
Measured: During the intervention
Number of participants requiring hospital readmission after discharge
Measured: 7 days after the end of interventions
Number of adverse events
especially incidence of acute otitis media and pneumonia
Measured: 7 days after the end of interventions
Worsening of clinical status, including the following:
PICU admission The need for oxygen supplementation via HNFC; Bronchospasm within 30 minutes of a nebulised study treatment as indicated by an increase/worsening of the RDAI of <4 points.
Measured: During the intervention
Value of clinical severity score (RDAI and Wang Scale)
30 minutes after intervention and 24 h, 48 h, and 72 h after enrolment
Measured: During the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2023
- Study start1 Nov 2023
- Primary completion30 Apr 2025
- Study completion30 Apr 2025
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomization will occur within 24 hours of admission
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Szpital im. Św. Jadwigi Śląskiej
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Henryk Szymański, Szpital im. Św. Jadwigi Śląskiej
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06069336
- Sponsor's protocol ID
- 1/2023
- Status last verified
- May 2025
- First submitted
- 23 Sep 2023
- Last updated
- 18 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The datasets used and/or generated during this study will be made available after the publication of results
Publications
Szupienko S, Buczek A, Szymanski H. Nebulised 3% hypertonic saline versus 0.9% saline for treating patients hospitalised with acute bronchiolitis: protocol for a randomised, double-blind, multicentre trial. BMJ Open. 2023 Nov 27;13(11):e080182. doi: 10.1136/bmjopen-2023-080182.
PubMed 38011984
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nebulised 3% Hypertonic Saline Versus 0.9% Saline for Treating Patients Hospitalized With Acute Bronchiolitis: Protocol of a Randomized, Double-blind, Multicentre Trial
- ClinicalTrials.gov ID
- NCT06069336
- Acronym / sponsor ID
- 1/2023
- Conditions
- Bronchiolitis
- Keywords
- hypertonic saline, infants, RCT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Szpital im. Św. Jadwigi ŚląskiejUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 30 Apr 2025 (actual)
- Study completion
- 30 Apr 2025 (actual)
- First posted
- 5 Oct 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.
Bronchiolitis is an acute viral infection of the lower respiratory tract. It is most commonly caused by respiratory syncytial virus (RSV). Only supportive therapy, including suctioning nasal secretions, water-electrolyte balance maintenance, and oxygen supplementation when needed, is recommended. The inhalation of 3% hypertonic saline is not recommended in bronchiolitis management. However, a recently published meta-analysis revealed that the inhalation of hypertonic saline can reduce the risk of hospitalisation for outpatients with bronchiolitis, while resulting in a shorter length of hospital stay and reduced severity of respiratory distress for inpatients, although the evidence is of low certainty.
The aim of the study is to assess the efficacy of nebulised hypertonic saline for the treatment of children hospitalised with bronchiolitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomization will occur within 24 hours of admission
| Arm | Type | Receives |
|---|---|---|
| Hypertonic saline | Active comparator | Drug: Hypertonic saline3% hypertonic saline (NEBU-dose hypertonic). The treatment will be delivered through nebulisation using oxygen with 5 litres of O2 flow, or through a compressed air-driven jet nebuliser, every 6 hours for three times daily with a night break, until discharge. |
| Normal saline | Placebo comparator | Drug: Normal saline0,9% normal saline (NEBU-dose isotonic).The treatment will be delivered through nebulisation using oxygen with 5 litres of O2 flow, or through a compressed air-driven jet nebuliser, every 6 hours for three times daily with a night break, until discharge. |
Who may qualify
- Ages
- 5 weeks to 24 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (11 listed)
- Children admitted to the hospital with the clinical diagnosis of acute bronchiolitis, which is defined as an apparent viral respiratory tract infection associated with airway obstruction manifested by at least one of following symptoms:
- Aged 5 weeks - 24 months old.
- A caregiver must provide written informed consent.
Key exclusion criteria (10 listed)
- Infants hospitalised with severe bronchiolitis (requiring mechanical ventilation or intensive care, or oxygen saturation < 85% on room air).
- History of prematurity (gestational age <34 weeks).
- Diagnosis of a clinically significant chronic disease (cardiac, respiratory, neuromuscular, or metabolic).
- Immunodeficiency.
- Gastro-oesophageal reflux.
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 |
|---|---|---|
| Hypertonic salineNebulised 3% hypertonic saline (NEBU-dose hypertonic). Nebulisation will be performed by trained study nurses or by parents under the supervision of a nurse | Drug | Hypertonic saline |
| Normal saline0,9% normal saline (NEBU-dose isotonic). Nebulisation will be performed by trained study nurses or by parents under the supervision of a nurse | Drug | Normal saline |
Primary outcome
Length of hospital stay (LOS).
Time frame: From admission to hospital discharge
7 secondary outcomes
Number of participants requiring oxygen supplementation
Time frame: During the intervention
Duration of oxygen supplementation
Time frame: During the intervention
The time until the infant will be assessed as being 'fit for discharge'
Time frame: During the intervention
Number of participants requiring hospital readmission after discharge
Time frame: 7 days after the end of interventions
Number of adverse events
Time frame: 7 days after the end of interventions
Worsening of clinical status, including the following:
Time frame: During the intervention
Value of clinical severity score (RDAI and Wang Scale)
Time frame: During the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2025.
- Derived from this study: PubMed 38011984Szupienko S, Buczek A, Szymanski H. Nebulised 3% hypertonic saline versus 0.9% saline for treating patients hospitalised with acute bronchiolitis: protocol for a randomised, double-blind, multicentre trial. BMJ Open. 2023 Nov 27;13(11):e080182. doi: 10.1136/bmjopen-2023-080182.
- Individual participant dataSharing planned: Yes. The datasets used and/or generated during this study will be made available after the publication of results
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hypertonic saline and Normal saline in people with Bronchiolitis, run by Szpital im. Św. Jadwigi Śląskiej at 3 sites in Poland.
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 11 inclusion and 10 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: finished, as of the sponsor's last update on 18 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of hospital stay (LOS). (time frame: From admission to hospital discharge). 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 NCT06069336, 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 18 May 2025; AzTrials last refreshed its copy on 31 Oct 2026.