A Phase 3 interventional study of Hypertonic Saline Solution, 1 Ml and Adrenaline in Acute Bronchiolitis Due to Respiratory Syncytial Virus, sponsored by Combined Military Hospital, Pakistan. Recruiting at 1 site in Pakistan. Open to participants aged 1 Month to 2 Years. Per ClinicalTrials.gov, last updated 2024-08-22.
Sponsored by Combined Military Hospital, Pakistan · Phase 3, Interventional, and Treatment
The goal of this clinical trial is to compare the efficacy of hypertonic saline nebulization with adrenaline nebulization in the treatment of acute bronchiolitis in children. Main aim is to evaluate the following in both group of patients
This is a double-blind clinical trial that will include all admitted patients with acute bronchiolitis, meeting inclusion criteria, admitted in Pediatrics department Combined Military Hospital Nowshera. Patients will be divided into two groups randomly. Group I patients will be nebulized with drug adrenaline every 6 hours and group II patients will be nebulized with hypertonic saline every 6 hours. After 24 hours and 48 hours of nebulization, researchers will record WDF score by measuring respiratory rate, heart rate, chest retractions, chest auscultation findings and SPO₂ levels. All data will be recorded on a research Performa including length of hospital stay. Data will be entered on SPSS to calculate results. Independent sample t-test was used to measure the effect of two drugs on the length of hospital stay and improvement of respiratory score with a 95% confidence interval. P value less than 0.05 will be considered as significant.
289 studies on the registry are indexed under Bronchiolitis; 51 are open to participants now.
This study's planned enrollment of 60 is below the median of 100 across 195 interventional studies indexed under Bronchiolitis.
Browse Bronchiolitis studies →Combined Military Hospital, Pakistan is the lead sponsor of 15 studies on the registry; 4 are open to participants now.
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Exclusion Criteria:
children with co-exiting illnesses like
First group of patients diagnosed as acute bronchiolitis will be nebulized with hypertonic saline every 6 hours and data will be recorded on a Performa
Drug: Hypertonic Saline Solution, 1 Ml
Second group of patients will be nebulized with adrenaline every 6 hours and data will be recorded on a Performa
Drug: Adrenaline
Dilute 0.3 ml hypertonic saline with 3 ml normal saline for nebulization
Also known as: Drug A
dilute 0.3 ml adrenaline with 3 ml normal saline for nebulization
Also known as: Drug B
Wood-Downes-Ferres clinical score calculation
A score of 0-3 mild, 4-6 moderately ill, \>6 severely ill
Time frame: at 24 and 48 hours of treatment
total length of hospitalization
less than 1 week, more than 1 week,
Time frame: less than 7 days, 7-10 days, 10-14 days
Plan to share: Undecided — After informed consent of participants and ethical committee approval, it will be shared.
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Studies of the drug tested here: Epinephrine
Combined Military Hospital, Pakistan