| NCT ID | NCT06719284 |
| Status | Recruiting |
| Phase | — |
| Sponsor | King's College Hospital NHS Trust |
| Condition | High Frequency Oscillation |
| Study Type | INTERVENTIONAL |
| Enrollment | 27 participants |
| Start Date | 2025-02-26 |
| Primary Completion | 2026-09-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 27 participants in total. It began in 2025-02-26 with a primary completion date of 2026-09-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Mechanical ventilation (MV) is life saving for infants requiring respiratory support in the newborn period but its use has been associated with complications. High frequency oscillation (HFO) is a type of MV that delivers small volumes of gas across the lungs at fast frequencies. HFO is a lung protective strategy but it has also been linked to brain injury due to low carbon dioxide tensions. High-frequency oscillation with volume-targeted ventilation (HFO\&VTV) is a new mode of HFO in which the clinician sets a target volume of gas to be delivered to the lungs at fast rates to decrease the lung injury related to the ventilator. Further, HFO\&VTV achieves better control of carbon dioxide levels and may therefore protect against brain injury. Currently, there are no written guidelines about the use of HFO\&VTV. This study aim to determine the safety profile of HFO\&VTV compared to HFO by comparing the velocity of blood flow to the brain in term born infants and the cardiac output in term and preterm infants during the two modes. The investigators will also determine the optimum starting value of the target tidal volume during HFOV\&VTV. Infants will be studied at three different target tidal volumes for a period of 10-20 minutes each. A cranial ultrasound (for term infants only) and bedside echocardiogram will be performed at the end of each period.
Eligibility 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.
Contact & Investigator
Theodore Dassios, Professor
PRINCIPAL INVESTIGATOR
King's College Hospital NHS Trust
Frequently Asked Questions
Who can join the NCT06719284 clinical trial?
This trial is open to participants of all sexes, aged 22 Weeks or older, up to 1 Year, studying High Frequency Oscillation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06719284 currently recruiting?
Yes, NCT06719284 is actively recruiting participants. Contact the research team at ourania.kaltsogianni@nhs.net for enrollment information.
Where is the NCT06719284 trial being conducted?
This trial is being conducted at London, United Kingdom.
Who is sponsoring the NCT06719284 clinical trial?
NCT06719284 is sponsored by King's College Hospital NHS Trust. The principal investigator is Theodore Dassios, Professor at King's College Hospital NHS Trust. The trial plans to enroll 27 participants.