NCT06093152

Video Assisted Study of Salbutamol Response in Viral Wheezing

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 50 (estimated)
• Sponsor: University of Oulu · Academic / Other
• Sex: All
• Age: 6 Months – 24 Months
• Healthy volunteers: Not accepted

Summary

The study is video assisted cross-over study evaluating the effect of inhaled salbutamol in wheeze in children 6-24 months old.

Detailed description

The object of the study is to evaluate the effect of inhaled salbutamol in wheeze in children 6-24 months old. In despite of the lack of evidence of salbutamol, it is considered the gold standard in acute wheezing. Placebo-controlled study would be unethical so all participants are treated with salbutamol based on current guidelines. Instead, participants serve as control subjects of their own which is executed by a type video assisted cross-over study. Participants are filmed before and after the treatment. Afterwards a panel of pediatricians not participating in the treatment of the participants independently evaluates the difficulty of the wheeze. Videos are randomly arranged and members of the panel are blinded to the time point (before/after) of videos. In addition, collected videos are analyzed using machine vision. Biosignals are collected from the videos and evaluated using algorithms in order to show that machine vision can be utilized to evaluate the difficulty of wheezing. The machine vision analysis is compared to the evaluation of the panel of pediatricians.

Conditions

• Wheezing

Interventions

Type	Name	Description
DRUG	Salbutamol	Inhaled salbutamol (SABA, selective beta2-adrenergic receptor agonist) 0,1 mg 4-6 puffs 3-4 times every 20 minutes administered by OptiChamber holding chamber.

Timeline

• Start date: 2023-10-23
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2023-10-23
• Last updated: 2025-02-13

Locations

1 site across 1 country: Finland