Acute BronchiolitisPhase 2/3NCT06558461
Nebulised 3% Hypertonic Saline in Infants With Acute Bronchiolitis
A Phase 2/3 study testing 3% Sodium Chloride in people with Acute Bronchiolitis, run by Can Tho University of Medicine and Pharmacy at 1 site in Vietnam.
Trial summary
This study aims to determine the efficacy of nebulising 3% hypertonic saline in improving clinical symptoms and reducing the length of hospital stay in infants with acute bronchiolitis. Read more about this study
- Who is it for?
- Ages 1 month to 24 months
- Conditions the study is for
- Acute Bronchiolitis
- What is being tested?
- 3% Sodium Chloride
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteVietnam
- Study dates
- 1 Jun 2022to 28 May 2024
- Phase
- Phase 2/3
- 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 1 month to 24 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Pediatric patients diagnosed with acute bronchiolitis from 1 to 24 months old at Can Tho Children's Hospital.
Who cannot join
- Family members do not agree to let the child participate in the study.
- Severe respiratory failure required mechanical ventilation.
- The patient left on his own during treatment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluating the Efficacy of Nebulised 3% Hypertonic Saline for Acute Bronchiolitis in Infants: A Study at Can Tho Children's Hospital, 2022-2024
This study aims to determine the efficacy of nebulising 3% hypertonic saline in improving clinical symptoms and reducing the length of hospital stay in infants with acute bronchiolitis.
Read the detailed description
Bronchiolitis is the most prevalent disease in infants, especially children younger than two years old. Clinical manifestations vary from mild to severe, even life-threatening respiratory failure. Airway oedema and mucus plugging are the principal pathological features in infants with acute bronchiolitis. Nebulising 3% hypertonic saline solution may reduce these pathological changes, but the evidence remains equivocal.
- Conditions
- Acute Bronchiolitis
- Being tested
- 3% Sodium Chloride, Standard care
- Keywords
- Bronchiolitis, 3% hypertonic saline
- Medical subject headings
- Bronchiolitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3% Sodium ChlorideDrug
4ml nebulized three times daily
Standard careOther
Standard care
| Study group | Role | What they receive |
|---|---|---|
| 3% hypertonic saline | Experimental | Children will receive standard medical care coordinating with nebulizing 3% hypertonic saline in the treatment of bronchiolitis. They received 4ml of 3% Sodium chloride, nebulized three times daily until discharge. Receives: Drug: 3% Sodium Chloride |
| Control | Active comparator | Children will only receive standard medical care. Receives: Other: Standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improve clinical severity score after three days of treatment with nebulized 3% hypertonic saline.
The clinical severity score is a validated, self-reported instrument assessing clinical severity over treatment. Possible scores range from 0 (mild) to 12 (severity).
Measured: three days
Secondary outcomes (1)
Shorten the mean length of hospital stays in infants with bronchiolitis after treatment with nebulized 3% hypertonic saline.
The mean length of hospital stays is the days from admission to discharge of all participants.
Measured: From admission to discharge, up to 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2024
- Study start1 Jun 2022
- Primary completion27 May 2024
- Study completion28 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomized controlled open-label parallel-arm clinical trial, with allocation 1:1, was conducted to investigate whether nebulizing 3% hypertonic saline will improve clinical symptoms and reduce the length of hospital stay in bronchiolitis compared with the control group.
- Masking
- None (open label)
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Can Tho University of Medicine and Pharmacy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Van VuTuong Le, MD, Principal investigator, Can Tho University of Medicine and Pharmacy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06558461
- Sponsor's protocol ID
- 173
- Status last verified
- Aug 2024
- First submitted
- 14 Aug 2024
- Last updated
- 16 Aug 2024
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected individual participant data
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Efficacy of Nebulised 3% Hypertonic Saline for Acute Bronchiolitis in Infants: A Study at Can Tho Children's Hospital, 2022-2024
- ClinicalTrials.gov ID
- NCT06558461
- Acronym / sponsor ID
- 173
- Conditions
- Acute Bronchiolitis
- Keywords
- Bronchiolitis, 3% hypertonic saline
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Can Tho University of Medicine and PharmacyUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 27 May 2024 (actual)
- Study completion
- 28 May 2024 (actual)
- First posted
- 16 Aug 2024 (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.
This study aims to determine the efficacy of nebulising 3% hypertonic saline in improving clinical symptoms and reducing the length of hospital stay in infants with acute bronchiolitis.
Detailed description
Bronchiolitis is the most prevalent disease in infants, especially children younger than two years old. Clinical manifestations vary from mild to severe, even life-threatening respiratory failure. Airway oedema and mucus plugging are the principal pathological features in infants with acute bronchiolitis. Nebulising 3% hypertonic saline solution may reduce these pathological changes, but the evidence remains equivocal.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A randomized controlled open-label parallel-arm clinical trial, with allocation 1:1, was conducted to investigate whether nebulizing 3% hypertonic saline will improve clinical symptoms and reduce the length of hospital stay in bronchiolitis compared with the control group.
| Arm | Type | Receives |
|---|---|---|
| 3% hypertonic saline | Experimental | Drug: 3% Sodium ChlorideChildren will receive standard medical care coordinating with nebulizing 3% hypertonic saline in the treatment of bronchiolitis. They received 4ml of 3% Sodium chloride, nebulized three times daily until discharge. |
| Control | Active comparator | Other: Standard careChildren will only receive standard medical care. |
Who may qualify
- Ages
- 1 month to 24 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Pediatric patients diagnosed with acute bronchiolitis from 1 to 24 months old at Can Tho Children's Hospital.
Key exclusion criteria (3 listed)
- Family members do not agree to let the child participate in the study.
- Severe respiratory failure required mechanical ventilation.
- The patient left on his own during treatment.
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 |
|---|---|---|
| 3% Sodium Chloride4ml nebulized three times daily | Drug | 3% hypertonic saline |
| Standard careStandard care | Other | Control |
Primary outcome
Improve clinical severity score after three days of treatment with nebulized 3% hypertonic saline.
Time frame: three days
The clinical severity score is a validated, self-reported instrument assessing clinical severity over treatment. Possible scores range from 0 (mild) to 12 (severity).
1 secondary outcome
Shorten the mean length of hospital stays in infants with bronchiolitis after treatment with nebulized 3% hypertonic saline.
Time frame: From admission to discharge, up to 14 days
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 16 Aug 2024.
- Individual participant dataSharing planned: Yes. All collected individual participant data
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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.
Van VuTuong Le, MD principal investigator
Can Tho University of Medicine and Pharmacy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing 3% Sodium Chloride in people with Acute Bronchiolitis, run by Can Tho University of Medicine and Pharmacy at 1 site in Vietnam.
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 1 inclusion and 3 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 16 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Improve clinical severity score after three days of treatment with nebulized 3% hypertonic saline. (time frame: three days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Aug 2024.