An interventional study of 3% Hypertonic Saline and Intervention: Salbutamol (Ventolin) in BRONCHIOLITIS, sponsored by University of Health Sciences Lahore. Not yet recruiting. Open to participants aged 2 Months to 24 Months. Per ClinicalTrials.gov, last updated 2024-10-30.
Sponsored by University of Health Sciences Lahore · Not applicable, Interventional, and Treatment
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.
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
289 studies on the registry are indexed under Bronchiolitis; 51 are open to participants now.
This study's planned enrollment of 100 is close to the median of 100 across 195 interventional studies indexed under Bronchiolitis.
Browse Bronchiolitis studies →University of Health Sciences Lahore is the lead sponsor of 83 studies on the registry; 52 are open to participants now.
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Exclusion Criteria:
Infant with metabolic disorder
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.
Procedure: 3% Hypertonic Saline
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: Intervention: Salbutamol (Ventolin)
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.
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.
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.
Time frame: 5 days
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Dec 2024; primary completion for Feb 2025, 2 months later.
Of 54 non-industry interventional studies with no phase under Bronchiolitis, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 35. This study's planned 2 months is below that.
Counting every sponsor, half of 57 studies reached it within 22 months; a quarter within 11 and three quarters within 35.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.
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University of Health Sciences Lahore