BRONCHIOLITISNCT06665711
Comparison of 3% Hypertonic Saline and Salbutamol in Children With Bronchiolitis
A study testing 3% Hypertonic Saline and Intervention: Salbutamol (Ventolin) in people with BRONCHIOLITIS, run by University of Health Sciences Lahore.
Trial summary
Bronchiolitis is a common lower respiratory tract infection that often leads to hospitalization in infants. The use of nebulized 3% hypertonic saline for treating bronchiolitis is being explored as an alternative to Salbutamol. Read more about this study
- Who is it for?
- Ages 2 to 24 months
- Conditions the study is for
- BRONCHIOLITIS
- What is being tested?
- 3% Hypertonic Saline and Intervention: Salbutamol (Ventolin)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 3 Dec 2024to 10 Mar 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 2 to 24 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Infants aged 2-24 months
- Gender; Both Male and female patients.
- Presenting with bronchiolitis (as per operational definition)
Who cannot join
- Infant with metabolic disorder
- Congenital heart disease
- Immune deficiency
Trial locations and contacts
No sites are listed yet.
About this study
Official title: COMPARISON BETWEEN 3% HYPERTONIC SALINE VERSUS SALBUTAMOL IN CHILDREN WITH BRONCHIOLITIS
Bronchiolitis is a common lower respiratory tract infection that often leads to hospitalization in infants. The use of nebulized 3% hypertonic saline for treating bronchiolitis is being explored as an alternative to Salbutamol. In nebulizers, normal saline serves as a diluent, allowing water molecules or drugs to be inhaled into the lungs. However, there has been limited research on this topic, and no local trials have been conducted.
This study aims to compare the effectiveness of 3% hypertonic saline and Salbutamol in treating bronchiolitis. A randomized controlled trial will be conducted at the Department of Pediatric Medicine, Services Institute of Medical Sciences, Lahore, over one year, involving 100 infants divided into two groups: one receiving 3% hypertonic saline and the other receiving Salbutamol. The RDAI score will be evaluated before and during treatment to assess recovery time. Data will be collected using a proforma and analyzed with SPSS v25. The study aims to determine which treatment leads to faster symptom control and shorter hospital stays, with significance defined as a p-value ≤0.05. The findings will guide future treatment choices for infants with bronchiolitis.
Read the detailed description
Bronchiolitis, an infection of the lower respiratory tract, is one of the common reasons why the infants are hospitalized. The effectiveness of nebulized hypertonic saline (3%) in case of bronchiolitis is under discussion around the globe. With the use of normal saline as the diluent in nebulizers and the oxygen as vaporizer, the water molecules or drugs can be breathed through the mouth or nose and spread to the respiratory tract and lungs by the airflow. This is how, Salbutamol can be replaced by 3% hypertonic saline. However, a little work has been done in the past and no trials has yet been conducted at local setup. The objective of this study is to compare the efficacy of 3% hypertonic saline versus Salbutamol in the treatment of bronchiolitis. A Randomized controlled Trial will be conducted at Department of Pediatric Medicine, Services Institute of Medical Sciences Lahore, for a period of one year. A sample size of 100 cases; 50 in each group will be included through Nonprobability consecutive sampling and will be divided randomly into two groups. In group H, 3% hypertonic saline solution will be provided. In group V, Salbutamol will be taken. Before and on the treatment day, the RDAI score will be examined for evaluation. A complete recovery time will be noted. Data will be filled in a proforma for record. SPSS v25 software will be used for data analysis. Both groups will be compared simultaneously to take mean time to control symptoms by using independent samples t-test and RDAI score. P-value ≤0.05 will be taken as significant. Therefore, selecting an appropriate drug with less chances of failure can be proved fruitful and can significantly reduce the hospital stay with early recovery. The results of this study will help to choose a better drug in future in the treatment of infants against bronchiolitis
- Conditions
- BRONCHIOLITIS
- Being tested
- 3% Hypertonic Saline, Intervention: Salbutamol (Ventolin)
- Keywords
- BRONCHIOLITIS
- Medical subject headings
- Bronchiolitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3% Hypertonic SalineProcedure or surgery
In this arm of the study, participants will receive nebulized 3% hypertonic saline as the primary treatment for bronchiolitis. The administration of hypertonic saline is aimed at reducing airway edema and improving mucociliary clearance in infants experiencing respiratory distress due to bronchiolitis.
Intervention: Salbutamol (Ventolin)Procedure or surgery
In this arm of the study, participants will receive nebulized Salbutamol, a bronchodilator commonly used in the management of bronchospasm associated with respiratory conditions, including bronchiolitis. The objective is to evaluate the effectiveness of Salbutamol in comparison to 3% hypertonic saline in improving the clinical outcomes of infants with bronchiolitis.
| Study group | Role | What they receive |
|---|---|---|
| Intervention: 3% Hypertonic Saline | Active comparator | In this arm of the study, participants will receive nebulized 3% hypertonic saline as the primary treatment for bronchiolitis. The administration of hypertonic saline is aimed at reducing airway edema and improving mucociliary clearance in infants experiencing respiratory distress due to bronchiolitis. Receives: Procedure: 3% Hypertonic Saline |
| Intervention: Salbutamol (Ventolin) | Active comparator | In this arm of the study, participants will receive nebulized Salbutamol, a bronchodilator commonly used in the management of bronchospasm associated with respiratory conditions, including bronchiolitis. The objective is to evaluate the effectiveness of Salbutamol in comparison to 3% hypertonic saline in improving the clinical outcomes of infants with bronchiolitis. Receives: Procedure: Intervention: Salbutamol (Ventolin) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Respiratory Distress Assessment Instrument (RDAI) Score
The outcome measures of this study include the change in Respiratory Distress Assessment Instrument , assessed at baseline and on days 1, 2, 3, 4, and 5 of treatment, as well as the time to complete recovery, defined as achieving an score of less than 5.
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2024
- Study start3 Dec 2024 (estimated)
- Primary completion6 Feb 2025 (estimated)
- Study completion10 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BRONCHIOLITISStudies of the same condition, open and under way.
- More trials run by University of Health Sciences LahoreThe sponsor's other registered studies.
- 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
- This study will employ a randomized controlled trial (RCT) design, which is considered the gold standard for evaluating the efficacy of interventions. The primary aim is to compare the effectiveness of 3% hypertonic saline against Salbutamol (Ventolin) in treating bronchiolitis in children.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Health Sciences Lahore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qasim Niaz, University of Health Sciences Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06665711
- Sponsor's protocol ID
- Exp125
- Status last verified
- Oct 2024
- First submitted
- 29 Oct 2024
- Last updated
- 30 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COMPARISON BETWEEN 3% HYPERTONIC SALINE VERSUS SALBUTAMOL IN CHILDREN WITH BRONCHIOLITIS
- ClinicalTrials.gov ID
- NCT06665711
- Acronym / sponsor ID
- Exp125
- Conditions
- BRONCHIOLITIS
- Keywords
- BRONCHIOLITIS
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of Health Sciences LahoreUniversity, hospital or other
- Study start
- 3 Dec 2024 (estimated)
- Primary completion
- 6 Feb 2025 (estimated)
- Study completion
- 10 Mar 2025 (estimated)
- First posted
- 30 Oct 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.
Bronchiolitis is a common lower respiratory tract infection that often leads to hospitalization in infants. The use of nebulized 3% hypertonic saline for treating bronchiolitis is being explored as an alternative to Salbutamol. In nebulizers, normal saline serves as a diluent, allowing water molecules or drugs to be inhaled into the lungs. However, there has been limited research on this topic, and no local trials have been conducted.
This study aims to compare the effectiveness of 3% hypertonic saline and Salbutamol in treating bronchiolitis. A randomized controlled trial will be conducted at the Department of Pediatric Medicine, Services Institute of Medical Sciences, Lahore, over one year, involving 100 infants divided into two groups: one receiving 3% hypertonic saline and the other receiving Salbutamol. The RDAI score will be evaluated before and during treatment to assess recovery time. Data will be collected using a proforma and analyzed with SPSS v25. The study aims to determine which treatment leads to faster symptom control and shorter hospital stays, with significance defined as a p-value ≤0.05. The findings will guide future treatment choices for infants with bronchiolitis.
Detailed description
Bronchiolitis, an infection of the lower respiratory tract, is one of the common reasons why the infants are hospitalized. The effectiveness of nebulized hypertonic saline (3%) in case of bronchiolitis is under discussion around the globe. With the use of normal saline as the diluent in nebulizers and the oxygen as vaporizer, the water molecules or drugs can be breathed through the mouth or nose and spread to the respiratory tract and lungs by the airflow. This is how, Salbutamol can be replaced by 3% hypertonic saline. However, a little work has been done in the past and no trials has yet been conducted at local setup. The objective of this study is to compare the efficacy of 3% hypertonic saline versus Salbutamol in the treatment of bronchiolitis. A Randomized controlled Trial will be conducted at Department of Pediatric Medicine, Services Institute of Medical Sciences Lahore, for a period of one year. A sample size of 100 cases; 50 in each group will be included through Nonprobability consecutive sampling and will be divided randomly into two groups. In group H, 3% hypertonic saline solution will be provided. In group V, Salbutamol will be taken. Before and on the treatment day, the RDAI score will be examined for evaluation. A complete recovery time will be noted. Data will be filled in a proforma for record. SPSS v25 software will be used for data analysis. Both groups will be compared simultaneously to take mean time to control symptoms by using independent samples t-test and RDAI score. P-value ≤0.05 will be taken as significant. Therefore, selecting an appropriate drug with less chances of failure can be proved fruitful and can significantly reduce the hospital stay with early recovery. The results of this study will help to choose a better drug in future in the treatment of infants against bronchiolitis
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study will employ a randomized controlled trial (RCT) design, which is considered the gold standard for evaluating the efficacy of interventions. The primary aim is to compare the effectiveness of 3% hypertonic saline against Salbutamol (Ventolin) in treating bronchiolitis in children.
| Arm | Type | Receives |
|---|---|---|
| Intervention: 3% Hypertonic Saline | Active comparator | Procedure: 3% Hypertonic SalineIn this arm of the study, participants will receive nebulized 3% hypertonic saline as the primary treatment for bronchiolitis. The administration of hypertonic saline is aimed at reducing airway edema and improving mucociliary clearance in infants experiencing respiratory distress due to bronchiolitis. |
| Intervention: Salbutamol (Ventolin) | Active comparator | Procedure: Intervention: Salbutamol (Ventolin)In this arm of the study, participants will receive nebulized Salbutamol, a bronchodilator commonly used in the management of bronchospasm associated with respiratory conditions, including bronchiolitis. The objective is to evaluate the effectiveness of Salbutamol in comparison to 3% hypertonic saline in improving the clinical outcomes of infants with bronchiolitis. |
Who may qualify
- Ages
- 2 to 24 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Infants aged 2-24 months
- Gender; Both Male and female patients.
- Presenting with bronchiolitis (as per operational definition)
Key exclusion criteria (3 listed)
- Infant with metabolic disorder
- Congenital heart disease
- Immune deficiency
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% Hypertonic SalineIn this arm of the study, participants will receive nebulized 3% hypertonic saline as the primary treatment for bronchiolitis. The administration of hypertonic saline is aimed at reducing airway edema and improving mucociliary clearance in infants experiencing respiratory distress due to bronchiolitis. | Procedure or surgery | Intervention: 3% Hypertonic Saline |
| Intervention: Salbutamol (Ventolin)In this arm of the study, participants will receive nebulized Salbutamol, a bronchodilator commonly used in the management of bronchospasm associated with respiratory conditions, including bronchiolitis. The objective is to evaluate the effectiveness of Salbutamol in comparison to 3% hypertonic saline in improving the clinical outcomes of infants with bronchiolitis. | Procedure or surgery | Intervention: Salbutamol (Ventolin) |
Primary outcome
Change in Respiratory Distress Assessment Instrument (RDAI) Score
Time frame: 5 days
The outcome measures of this study include the change in Respiratory Distress Assessment Instrument , assessed at baseline and on days 1, 2, 3, 4, and 5 of treatment, as well as the time to complete recovery, defined as achieving an score of less than 5.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2024.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing 3% Hypertonic Saline and Intervention: Salbutamol (Ventolin) in people with BRONCHIOLITIS, run by University of Health Sciences Lahore.
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 3 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: status not confirmed, as of the sponsor's last update on 30 Oct 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Qasim Niaz, Post Graduate Resident (111-33-33-66, info@uhs.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Respiratory Distress Assessment Instrument (RDAI) Score (time frame: 5 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 30 Oct 2024.