Recruiting

High Frequency Oscillatory Ventilation vs. High Frequency Jet Ventilation

Sponsor:

University of Utah

Code:

NCT04774848

Conditions

Congenital Diaphragmatic Hernia

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

Interventions

High Frequency Jet Ventilator

High Frequency Oscillatory Ventilator

Study Details

Brief summary:

The purpose of this study is to conduct a prospective study of all congenital diaphragmatic hernia (CDH) neonates managed at the University of Utah newborn intensive care unit (NICU) and Primary Children's Hospital NICU that required mechanical ventilation at birth. As both high frequency jet ventilation (HFJV) and high frequency oscillatory ventilation (HFOV) are standard approaches to ventilatory support of all neonates including CDH, CDH infants will be randomized at the time of birth or admission to either HFJV or HFOV as initial ventilator mode, stratified by position of the liver in the abdomen or thorax (if known) by 24 hours of age. Measures of oxygenation, ventilation and hemodynamics of the CDH cohort managed on HFOV compared to those on HFJV.

Conditions

Congenital Diaphragmatic Hernia

Study ID

NCT04774848

Start date

Dec 30, 2020

Status verified date

Jan, 2025

Completion date

Aug 28, 2025

Anticipated

Primary completion date

Jun 30, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Admitted to either the University of Utah and/or Primary Children's Hospital NICU within 24 hours of birth
2. Requiring mechanical ventilation
3. Umbilical arterial line or peripheral arterial line in place
4. Obtained signed consent
5. Infant is ≤ 24 hours of age

Exclusion Criteria:

1. Severe anomaly

1. Chromosomal abnormalities
2. Major congenital anomalies, including cardiac, central nervous system and syndromes
2. Post-natal diagnosis > 24 hours of life
3. Unable to obtain consent for participation
4. Unable to randomize within 24 hours of life

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: High Frequency Jet Ventilation (HFJV) with intrathoracic liver

Babies known to have the presence of the liver in the intrathoracic space will be placed on the HFJV at delivery or as soon as possible after consent. During analysis, these babies will be compared to babies with intrathoracic liver and randomized to high frequency oscillating ventilator.

active comparator: High Frequency Jet Ventilation (HFJV) without intrathoracic liver

Babies who do not have any liver in the intrathoracic space will be placed on the HFJV at delivery or as soon as possible after consent. During analysis, these babies will be compared to babies without intrathoracic liver and randomized to high frequency oscillating ventilator.

active comparator: High Frequency Oscillatory Ventilation (HFOV) with intrathoracic liver

Babies known to have the presence of the liver in the intrathoracic space will be placed on the HFOV at delivery or as soon as possible after consent. During analysis, these babies will be compared to babies with intrathoracic liver and randomized to HFJV.

active comparator: High Frequency Oscillatory Ventilation (HFOV) without intrathoracic liver

Babies who do not have any liver in the intrathoracic space will be placed on the HFOV at delivery or as soon as possible after consent. During analysis, these babies will be compared to babies without intrathoracic liver and randomized to HFJV.

Interventions

High Frequency Jet Ventilator

HFJV provides short bursts of gas into the respiratory circuit at a rate of 240 to 600/min (4 to 11 Hz) and expiration is passive. It is used in conjunction with a conventional ventilator which provides positive end expiratory pressure (PEEP) and can also provide occasional sigh breaths.

High Frequency Oscillatory Ventilator

HFOV uses a piston diaphragm to generate alternating positive and negative pressure changes to give breaths of 300 to 900/min (5-15 Hz) given over a set mean airway pressure. Both inhalation and exhalation are active.

Primary outcome measure

  • Oxygenation Index (OI) at 24 hours of age [ Time Frame: 24 hours of age ]

Central Contacts and Locations

Central contacts

Michelle Yang, MD

801-581-7052michelle.yang@hsc.utah.edu

Carrie Rau

801-213-3360carrie.rau@hsc.utah.edu

Locations

Primary Children's Hospital

Recruiting

Salt Lake City, Utah, United States, 84113

Contacts

Michelle Yang, MD

801-581-7052michelle.yang@hsc.utah.edu

Kimberlee Weaver-Lewis, RN

801-507-7675kimberlee.weaverlewis@imail.org

Principal Investigator:

Michelle Yang, MD

University Hospital

Recruiting

Salt Lake City, Utah, United States, 84132

Contacts

Michelle Yang, MD

801-581-7052michell.yang@hsc.utah.edu

Carrie Rau, RN

801-213-3360carrie.rau@hsc.utah.edu

Principal Investigator:

Michelle Yang, MD

More Information

Sponsor

University of Utah

Last update posted

Apr 4, 2025

Last verified

Jan, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Utah on 2025-04-04.