Optimising HFO&VTV in Newborn Infants

March 5, 2025 updated by: King's College Hospital NHS Trust

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)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a single centre, randomised cross-over trial in newborn infants requiring high-frequency oscillatory ventilation (HFOV) at any postnatal age. Infants with known intracerebral pathology (stroke, hydrocephalus, intracerebral haemorrhage, severe HIE) and congenital cardiac abnormalities will be excluded from the study. In preterm infants cerebral blood flow will not be studied as there is no clear evidence for the significance of the resistive index (RI) in the cerebral arteries to predict brain injury and neurodevelopmental outcomes.

The research team will identify infants based on the inclusion criteria and approach parents to discuss the study and provide information leaflets.

The investigators aim to recruit a minimum of 25 infants (13 preterm and 12 term infants) over 18 months.

Informed written consent will be requested from the parents or legal guardians of the infants and the attending Neonatal Consultant will be requested to verbally assent to the study.

All infants will be oscillated using SLE6000 ventilators. Ventilation settings will be adjusted by the clinical team as per unit's protocol.

Infants will be studied when clinically stable and a blood gas confirms that the carbon dioxide (CO2) levels are in the target range (4.5 to 6.5 kPa). Participants will receive HFO&VTV at targeted tidal volumes of 1.5, 2.0 and 2.5 ml/kg in random order for a period of 10-20 minutes each. Additionally, there will be a control period of 20 minutes between each tidal volume when infants will be switched to HFOV without volume-guarantee at the settings applied prior to the study. The order in which they receive the different levels of tidal volumes will be randomised using an excel random number generator.

Transcutaneous CO2 monitoring will be applied to the infants during the study. The resistive index (RI) as an indicator of cerebral blood flow in term infants and the cardiac output of all paticipants will be assessed at the last five minutes of each twenty-minute period. Measurements of the RI and the cardiac output will also be made during the last five minutes of the control periods and the results will be averaged.

The nurse to patient ration will be according to the unit's protocol that is determined on the patient's acuity.

The investigators will also record basic epidemiologic parameters such as sex, gestational age, birth weight, mode of delivery, Apgar scores, administration of surfactant, day of life at study, mechanical ventilation starting time and HFO starting time, and initial diagnosis.

Study Type

Interventional

Enrollment (Estimated)

27

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United Kingdom
      • London, United Kingdom, S£5 9RS
        • Recruiting
        • King's College Hospital
        • Contact:
          • Ourania Kaltsogianni, MSc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: High frequency oscillation at the settings applied prior to the study
Other: HFOV at the settings applied prior to the study
HFOV at the settings applied prior to the study
Active Comparator: High frequency oscillation with volume targeted ventilation
Other: HFO&VTV at targeted tidal volumes of 1.5, 2.0 and 2.5 ml/kg in random order
HFO&VTV at targeted tidal volumes of 1.5, 2.0 and 2.5 ml/kg in random order

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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 months
Through study completion, an average of 18 months

Secondary Outcome Measures

Outcome Measure
Time Frame
The change in cardiac output that will be assessed with bedside ECHO in all infants
Time Frame: Through study completion, an average of 18 months
Through study completion, an average of 18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

King's College Hospital NHS Trust

Investigators

  • Principal Investigator: Theodore Dassios, Professor, King's College Hospital NHS Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 26, 2025

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 1, 2026

Study Registration Dates

First Submitted

November 26, 2024

First Submitted That Met QC Criteria

December 2, 2024

First Posted (Actual)

December 5, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 5, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 349734

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on High Frequency Oscillation

Clinical Trials on HFOV at the settings applied prior to the study

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Singapore

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe