Optimizing ventilation techniques for newborn infants
Crossover Study of the Cerebral Blood Flow and Cardiac Output At Different Targeted Tidal Volumes During High Frequency Oscillation with Volume Targeted Ventilation (HFO&VTV)
This study is testing a new breathing method for newborns needing help with their lungs to see if it is safer than the usual method.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 27 (estimated) |
| Ages | 22 Weeks to 1 Year |
| Sex | All |
| Sponsor | King's College Hospital NHS Trust Academic / other |
| Locations | 1 site (London) |
| Trial ID | NCT06719284 on ClinicalTrials.gov |
What this trial studies
This study investigates a new method of mechanical ventilation called high-frequency oscillation with volume-targeted ventilation (HFO&VTV) for newborn infants requiring respiratory support. The trial aims to compare the safety profile of HFO&VTV against traditional high-frequency oscillatory ventilation (HFOV) by measuring blood flow velocity to the brain and cardiac output in term infants. A total of 25 infants will be recruited, and they will receive different tidal volumes of gas in a randomized order while being monitored for carbon dioxide levels. The study seeks to establish guidelines for the use of HFO&VTV in clinical practice.
Who should consider this trial
Good fit: Ideal candidates for this study are newborn infants of any gestation who are receiving high-frequency oscillatory ventilation.
Not a fit: Patients with known intracerebral pathology or congenital cardiac abnormalities may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could reduce lung injury and protect against brain injury in newborn infants requiring mechanical ventilation.
How similar studies have performed: While high-frequency oscillation has been studied, the specific combination of HFO&VTV is novel and has not been extensively tested in this context.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: -Newborn infants of any gestation receiving high frequency oscillatory ventilation Exclusion Criteria: * Infants with known intracerebral pathology (stroke, hydrocephalus, intracerebral hemorrhage, severe hypoxic ischemic encephalopathy). * Infants with congenital cardiac abnormalities.
Where this trial is running
London
- King's College Hospital — London, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Theodore Dassios, Professor — King's College Hospital NHS Trust
- Study coordinator: Ourania Kaltsogianni, MSc
- Email: ourania.kaltsogianni@nhs.net
- Phone: 0044+02032999000
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.