Weaning infants from high flow nasal support for bronchiolitis
Randomised Control Trial Comparing High Flow Weaning Strategies for Infants with Bronchiolitis: Pilot Study
NA · Cardiff and Vale University Health Board · NCT04287959
This study is testing the best ways to help infants with bronchiolitis safely stop using high flow nasal support after needing it for a while.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 4 Weeks to 12 Months |
| Sex | All |
| Sponsor | Cardiff and Vale University Health Board (other gov) |
| Locations | 1 site (Cardiff) |
| Trial ID | NCT04287959 on ClinicalTrials.gov |
What this trial studies
This trial focuses on infants diagnosed with bronchiolitis, a common respiratory infection that can lead to significant breathing difficulties. The study evaluates the effectiveness of High Flow Nasal Cannula (HFNC) therapy as a method of respiratory support, aiming to improve oxygen delivery and reduce the work of breathing in affected infants. Eligible participants are those aged between 4 weeks and 12 months who require HFNC support for more than 12 hours. The trial seeks to determine the best strategies for weaning infants off this support safely and effectively.
Who should consider this trial
Good fit: Ideal candidates are infants aged over 4 weeks and under 12 months diagnosed with bronchiolitis requiring HFNC support for more than 12 hours.
Not a fit: Patients who may not benefit include those requiring imminent intubation or ventilation, or those with pre-existing respiratory conditions.
Why it matters
Potential benefit: If successful, this approach could lead to improved management of bronchiolitis in infants, reducing hospital stays and associated healthcare costs.
How similar studies have performed: Other studies have shown promising results with HFNC therapy in managing bronchiolitis, indicating that this approach is gaining traction in clinical practice.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria: * Clinical diagnosis of bronchiolitis * Age \>4 weeks and \<12 months * Needs HFNC respiratory support in a ward setting for more than 12 hours Exclusion criteria: * Requirement for imminent intubation and ventilation or having received mechanical ventilation during the current hospital admission * Requirement for imminent CPAP support * Pre-existing or concomitant, non-viral respiratory infection * Pre-existing respiratory disease * Ready to wean high-flow after \<12 hours of its initiation * Weight \>10kg * Low level of consciousness * Apnoeas\* * Cyanotic heart disease * Basilar skull fracture * Upper airway obstruction * Craniofacial malformations * Infants on home oxygen * Ex-premature infants (born at \<32 weeks gestation)
Where this trial is running
Cardiff
- Children's Hospital for Wales — Cardiff, United Kingdom (RECRUITING)
Study contacts
- Principal investigator: Martin O Edwards, PhD, BM — CAVUHB
- Study coordinator: Martin O Edwards, PhD, BM
- Email: martin.edwards4@wales.nhs.uk
- Phone: +442920743481
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.
Conditions: Respiratory Disease, Bronchiolitis, Viral, Infant Morbidity