High Frequency Oscillatory Ventilation Versus High Frequency Jet Ventilation for Congenital Diaphragmatic Hernia

High Frequency Oscillatory Ventilation Versus High Frequency Jet Ventilation as Initial Mode of Ventilation for Congenital Diaphragmatic Hernia

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.

Study Overview

• Status: Recruiting
• Conditions: Congenital Diaphragmatic Hernia
• Intervention / Treatment: Device: High Frequency Jet Ventilator; Device: High Frequency Oscillatory Ventilator

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Michelle Yang, MD; Phone Number: 801-581-7052; Email: michelle.yang@hsc.utah.edu
• Study Contact Backup: Name: Carrie Rau; Phone Number: 801-213-3360; Email: carrie.rau@hsc.utah.edu

Study Locations

• United States
  • Utah
    • Salt Lake City, Utah, United States, 84113
      • Recruiting
      • Primary Children's Hospital
      • Contact: Kimberlee Weaver-Lewis, RN; Phone Number: 801-507-7675; Email: kimberlee.weaverlewis@imail.org
      • Contact: Michelle Yang, MD; Phone Number: 801-581-7052; Email: michelle.yang@hsc.utah.edu
      • Principal Investigator: Michelle Yang, MD
    • Salt Lake City, Utah, United States, 84132
      • Recruiting
      • University Hospital
      • Principal Investigator: Michelle Yang, MD
      • Contact: Michelle Yang, MD; Phone Number: 801-581-7052; Email: michell.yang@hsc.utah.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 1 day (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Device: 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.
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.	Device: 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.
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.	Device: 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.
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.	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oxygenation Index (OI) at 24 hours of age	The OI will be measured at 24 hours of age using a standard of care arterial blood gas and oxygen settings. These measurements will then be compared between the stratified groups	24 hours of age

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PF ratio (PaO2/FiO2) measurements	These measurements will be determined at multiple time points for the first week of life. These measurements will be compared between groups.	up to one week
PF-PCO2 (PaO2/FiO2-PaCO2) measurements	These measurements will be determined at multiple time points for the first week of life. These measurements will be compared between groups.	up to one week
PaCO2 measurements	These measurements will be determined at multiple time points for the first week of life. These measurements will be compared between groups.	up to one week
Number of babies who received inhaled nitric oxide (iNO)	the number of babies who received treatment of iNO will be compared amongst the different groups	up to one week

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of babies who survive to discharge	the number of babies who survive and are discharged will be compared amongst the groups	up to one year
Number of babies who required extracorporeal membrane oxygenation (ECMO)	the number of babies who required ECMO will be compared amongst the groups	up to one year
Number of days on mechanical ventilation	the number of days each baby required intubation and mechanical ventilation by any type will be compared amongst the groups	up to one year

Collaborators and Investigators

• Sponsor: University of Utah
• Investigators: Principal Investigator: Michelle Yang, MD, University of Utah

Study record dates

Study Major Dates

• Study Start (Actual): December 30, 2020
• Primary Completion (Anticipated): October 31, 2024
• Study Completion (Anticipated): December 31, 2024

Study Registration Dates

• First Submitted: February 24, 2021
• First Submitted That Met QC Criteria: February 24, 2021
• First Posted (Actual): March 1, 2021

Study Record Updates

• Last Update Posted (Actual): September 28, 2022
• Last Update Submitted That Met QC Criteria: September 27, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Congenital Abnormalities; Pathological Conditions, Anatomical; Internal Hernia; Hernia; Hernias, Diaphragmatic, Congenital; Hernia, Diaphragmatic
• Other Study ID Numbers: 133683

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: Yes
• product manufactured in and exported from the U.S.: No