Optimising HFO&VTV in Newborn Infants
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age22-1
SponsorKing's College Hospital NHS Trust
About this trial
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
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
Infants with known intracerebral pathology (stroke, hydrocephalus, intracerebral hemorrhage, severe hypoxic ischemic encephalopathy).
Infants with congenital cardiac abnormalities.
Trial design
Design model
Crossover
Treatments tested in this trial
HFO&VTV at targeted tidal volumes of 1.5, 2.0 and 2.5 ml/kg in random order
Other interventionHFO\&VTV at targeted tidal volumes of 1.5, 2.0 and 2.5 ml/kg in random order
HFOV at the settings applied prior to the study
Other interventionHFOV at the settings applied prior to the study
Treatment groups
27 Participants
are divided into 2 treatment groupsGroup A: High frequency oscillation at the settings applied prior to the studyActive comparator 1 intervention
Group B: High frequency oscillation with volume targeted ventilationActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
The change in the Resistive Index (RI) that will be measured on term born infants using the anterior cerebral artery Doppler on cranial ultrasound
Time frame
Through study completion, an average of 18 monthsSecondary outcomes
1
The change in cardiac output that will be assessed with bedside ECHO in all infants
Time frame
Through study completion, an average of 18 monthsSponsors and contacts
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Source ClinicalTrials.gov