Optimising HFO&VTV in Newborn Infants

NCT06719284 | Recruiting

• 1 other identifier: 349734
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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.

Conditions

High Frequency Oscillation; Volume Targeted Ventilation

Keywords

high frequency oscillation; volume targeted ventilation; newborn infant

Outcome Measures

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

  Through study completion, an average of 18 months

Secondary Outcomes (1)

• The change in cardiac output that will be assessed with bedside ECHO in all infants

  Through study completion, an average of 18 months

Study Arms (2)

High frequency oscillation at the settings applied prior to the study

ACTIVE COMPARATOR

Other: HFOV at the settings applied prior to the study

High frequency oscillation with volume targeted ventilation

ACTIVE COMPARATOR

Other: HFO&VTV at targeted tidal volumes of 1.5, 2.0 and 2.5 ml/kg in random order

Interventions

HFO&VTV at targeted tidal volumes of 1.5, 2.0 and 2.5 ml/kg in random order OTHER

HFO\&VTV at targeted tidal volumes of 1.5, 2.0 and 2.5 ml/kg in random order

High frequency oscillation with volume targeted ventilation

HFOV at the settings applied prior to the study OTHER

HFOV at the settings applied prior to the study

High frequency oscillation at the settings applied prior to the study

Eligibility Criteria

• Age: 22 Weeks - 1 Year
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Newborn infants of any gestation receiving high frequency oscillatory ventilation

You may not qualify if:

• Infants with known intracerebral pathology (stroke, hydrocephalus, intracerebral hemorrhage, severe hypoxic ischemic encephalopathy).
• Infants with congenital cardiac abnormalities.

Sponsors & Collaborators

• King's College Hospital NHS Trust: lead

Study Sites (1)

King's College Hospital

London, S£5 9RS, United Kingdom

RECRUITING

Related Publications (4)

• Camfferman FA, de Goederen R, Govaert P, Dudink J, van Bel F, Pellicer A, Cools F; eurUS.brain group. Diagnostic and predictive value of Doppler ultrasound for evaluation of the brain circulation in preterm infants: a systematic review. Pediatr Res. 2020 Mar;87(Suppl 1):50-58. doi: 10.1038/s41390-020-0777-x.

  PMID: 32218536 BACKGROUND

• Tuzun F, Deliloglu B, Cengiz MM, Iscan B, Duman N, Ozkan H. Volume Guarantee High-Frequency Oscillatory Ventilation in Preterm Infants With RDS: Tidal Volume and DCO2 Levels for Optimal Ventilation Using Open-Lung Strategies. Front Pediatr. 2020 Mar 24;8:105. doi: 10.3389/fped.2020.00105. eCollection 2020.

  PMID: 32266185 BACKGROUND

• Iscan B, Duman N, Tuzun F, Kumral A, Ozkan H. Impact of Volume Guarantee on High-Frequency Oscillatory Ventilation in Preterm Infants: A Randomized Crossover Clinical Trial. Neonatology. 2015;108(4):277-82. doi: 10.1159/000437204. Epub 2015 Sep 1.

  PMID: 26330156 BACKGROUND

• Kaltsogianni O, Nanjundappa M, Okoye G, Greenough A, Dassios T. Effect of different targeted tidal volumes during high-frequency oscillation with volume-targeted ventilation on cerebral blood flow velocity and cardiac output: study protocol for a randomised crossover study. Trials. 2025 Oct 22;26(1):427. doi: 10.1186/s13063-025-09179-w.

  PMID: 41126304 DERIVED

Study Officials

• Theodore Dassios, Professor

  King's College Hospital NHS Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ourania Kaltsogianni, MSc

CONTACT

0044+02032999000; ourania.kaltsogianni@nhs.net

Theodore Dassios

CONTACT

theodore.dassios@nhs.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2024
• First Posted: December 5, 2024
• Study Start: February 26, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: March 10, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)