Comparing two devices for treating breathing difficulties in children
Comparing the Efficacy of Two Valved Holding Chambers for Bronchodilator Administration in 0.5-4 Years Old Children With Acute Wheezing - a Randomized Clinical Trial
This study is testing which of two devices helps young children with breathing problems feel better faster when they use a medication for their condition.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 6 Months to 4 Years |
| Sex | All |
| Sponsor | Tampere University Academic / other |
| Locations | 4 sites (Kuopio and 3 other locations) |
| Trial ID | NCT03900494 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of two different valved holding chambers (VHCs) in delivering salbutamol to children aged 6 months to 4 years experiencing acute respiratory distress due to bronchial obstruction. Eighty children will be randomly assigned to receive treatment with either the Babyhaler® or the Optichamber Diamond® VHC. The study aims to determine which device provides better symptom relief, reduces hospitalization rates, and minimizes symptom recurrence. Data will be collected through a manual case report form, focusing on the children's medical history and treatment responses.
Who should consider this trial
Good fit: Ideal candidates are children aged 6 months to 4 years who are experiencing respiratory distress due to bronchial obstruction.
Not a fit: Patients requiring immediate hospitalization or those with severe underlying medical conditions will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment options for children with acute breathing difficulties, enhancing their recovery and reducing hospitalizations.
How similar studies have performed: Previous studies have indicated significant differences in the efficacy of various VHCs, suggesting that this comparative approach could yield valuable insights.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: - Children (age 0.5-4 years) seeking medical aid due to respiratory distress caused by bronchial obstruction Exclusion Criteria: * requiring immediate admission to inpatient treatment in hospital * peripheral capillary oxygen saturation below 85% on admission * physician-confirmed pneumonia * inspiratory crackles on lung auscultation * croup * airway foreign body * impaired renal or liver function * immune compromised patient * general condition affecting the study per investigation judgement * bronchopulmonary dysplasia * long-acting beta-adrenoceptor agonist treatment * recruited to the ongoing study earlier * have been enrolled in a clinical trial within 30 days prior to admission * not willing to participate
Where this trial is running
Kuopio and 3 other locations
- Kuopio University Hospital — Kuopio, Finland (Recruiting)
- Oulu University Hospital — Oulu, Finland (Suspended)
- Terveystalo Tampere — Tampere, Finland (Recruiting)
- Tampere University Hospital — Tampere, Finland (Recruiting)
Study contacts
- Study coordinator: Peter Csonka, MD. PhD.
- Email: peter.csonka@tuni.fi
- Phone: +358503661103
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.