Video Assisted Study of Salbutamol Response in Viral Wheezing

NCT06093152 | Recruiting

• 2 other identifiers: 223/2021FIMEA/2023/003954
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Wheezing

Outcome Measures

Primary Outcomes (1)

• Change in modified RDAI

  RDAI = Respiratory Distress Assessment Instrument, modified to not include auscultation findings. Range 0-18. Higher score indicates more difficult respiratory distress. Evaluated by the blinded panel afterwards using collected videos. Videos collected immediately before and after the intervention.

  Within 3 hours of study entry

Secondary Outcomes (4)

• Change in saturation of peripheral oxygen

  Within 3 hours of study entry

• Change in auscultation finding

  Within 3 hours of study entry

• Change in the difficulty of the respiratory distress

  Within 3 hours of study entry

• Machine-vision assisted analysis of respiratory status

  Within 3 hours of study entry

Study Arms (2)

Before salbutamol

Participants before the administration of salbutamol

After salbutamol

Participants after the administration of salbutamol

Drug: Salbutamol

Interventions

Salbutamol DRUG

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.

After salbutamol

Eligibility Criteria

• Age: 6 Months - 24 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Participants are 6-24 months old children presenting to the emergency department for wheezing.

You may qualify if:

• Wheezing
• Salbutamol-treatment in emergency department prescribed

You may not qualify if:

• Need for immediate resuscitation
• Immediate transfer to ICU
• Suspicion of pneumonia based on the auscultation finding
• Suspicion of airway foreign body

Sponsors & Collaborators

• University of Oulu: lead

Study Sites (1)

Department of Pediatrics, Oulu University Hospital

Oulu, 90130, Finland

RECRUITING

MeSH Terms

Conditions

Respiratory Sounds

Interventions

Albuterol

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Phenethylamines; Ethylamines

Study Officials

• Terhi Tapiainen, Professor

  University of Oulu

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ville Lindholm, MD

CONTACT

+35883155283; Ville.a.lindholm@oulu.fi

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Pediatrics, Head of Pediatric Infectious Diseases and Emergency Department

Study Record Dates

• First Submitted: July 5, 2022
• First Posted: October 23, 2023
• Study Start: October 23, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 13, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)