Actively Recruiting
Video Assisted Study of Salbutamol Response in Viral Wheezing in Children 6-24 Months
Led by University of Oulu · Updated on 2025-02-13
50
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the effect of inhaled salbutamol on wheezing in children aged 6 to 24 months. Salbutamol is considered the standard treatment for acute wheezing despite limited evidence. The study uses a video-assisted cross-over design where each child acts as their own control to ethically compare the treatment effects without using a placebo group. Participants receive inhaled salbutamol administered by an OptiChamber holding chamber, with 4-6 puffs given 3-4 times every 20 minutes. The study captures videos of each child before and after treatment. A panel of pediatricians, unaware of the timing of the videos, independently assesses the severity of wheezing. Additionally, machine vision technology analyzes biosignals from the videos to evaluate wheezing severity and compare with pediatricians' evaluations. During the study, researchers measure changes in respiratory distress using the modified Respiratory Distress Assessment Instrument (RDAI), oxygen saturation levels, auscultation findings, and difficulty of breathing within three hours of study entry. The machine vision analysis of respiratory status is also assessed in this timeframe. The study involves careful observation and video analysis without altering standard care, with overall participation lasting only a few hours.
CONDITIONS
Brief Title
Video Assisted Study of Salbutamol Response in Viral Wheezing
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Child aged between 6 and 24 months
- Wheezing present
- Salbutamol treatment prescribed in emergency department
You will not qualify if you...
- Need for immediate resuscitation
- Immediate transfer to intensive care unit
- Suspicion of pneumonia based on lung examination
- Suspicion of airway foreign body
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Within 3 hours of study entry
Participants receive inhaled salbutamol treatment and are filmed before and after the administration to evaluate the response to the medication.
1 visit (in-person)
Trial Site Locations
Total: 1 location
1
Department of Pediatrics, Oulu University Hospital
Oulu, Finland, 90130
Actively Recruiting
Research Team
V
Ville Lindholm, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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