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

Primary Purpose

Congenital Diaphragmatic Hernia

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
High Frequency Jet Ventilator
High Frequency Oscillatory Ventilator
Sponsored by
University of Utah
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Congenital Diaphragmatic Hernia

Eligibility Criteria

undefined - 24 Hours (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Primary Children's HospitalRecruiting
  • University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

High Frequency Jet Ventilation (HFJV) with intrathoracic liver

High Frequency Jet Ventilation (HFJV) without intrathoracic liver

High Frequency Oscillatory Ventilation (HFOV) with intrathoracic liver

High Frequency Oscillatory Ventilation (HFOV) without intrathoracic liver

Arm Description

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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.
PaCO2 measurements
These measurements will be determined at multiple time points for the first week of life. These measurements will be compared between groups.
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

Full Information

First Posted
February 24, 2021
Last Updated
September 27, 2022
Sponsor
University of Utah
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1. Study Identification

Unique Protocol Identification Number
NCT04774848
Brief Title
High Frequency Oscillatory Ventilation Versus High Frequency Jet Ventilation for Congenital Diaphragmatic Hernia
Official Title
High Frequency Oscillatory Ventilation Versus High Frequency Jet Ventilation as Initial Mode of Ventilation for Congenital Diaphragmatic Hernia
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 30, 2020 (Actual)
Primary Completion Date
October 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Utah

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congenital Diaphragmatic Hernia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Infants stratified by presence of intrathoracic liver (yes/no) and are randomized to either high frequency jet ventilator or high frequency oscillating ventilator in a sequential 1:1 manner
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
High Frequency Jet Ventilation (HFJV) with intrathoracic liver
Arm Type
Active Comparator
Arm Description
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.
Arm Title
High Frequency Jet Ventilation (HFJV) without intrathoracic liver
Arm Type
Active Comparator
Arm Description
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.
Arm Title
High Frequency Oscillatory Ventilation (HFOV) with intrathoracic liver
Arm Type
Active Comparator
Arm Description
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.
Arm Title
High Frequency Oscillatory Ventilation (HFOV) without intrathoracic liver
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
High Frequency Jet Ventilator
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
High Frequency Oscillatory Ventilator
Intervention Description
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 Information:
Title
Oxygenation Index (OI) at 24 hours of age
Description
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
Time Frame
24 hours of age
Secondary Outcome Measure Information:
Title
PF ratio (PaO2/FiO2) measurements
Description
These measurements will be determined at multiple time points for the first week of life. These measurements will be compared between groups.
Time Frame
up to one week
Title
PF-PCO2 (PaO2/FiO2-PaCO2) measurements
Description
These measurements will be determined at multiple time points for the first week of life. These measurements will be compared between groups.
Time Frame
up to one week
Title
PaCO2 measurements
Description
These measurements will be determined at multiple time points for the first week of life. These measurements will be compared between groups.
Time Frame
up to one week
Title
Number of babies who received inhaled nitric oxide (iNO)
Description
the number of babies who received treatment of iNO will be compared amongst the different groups
Time Frame
up to one week
Other Pre-specified Outcome Measures:
Title
Number of babies who survive to discharge
Description
the number of babies who survive and are discharged will be compared amongst the groups
Time Frame
up to one year
Title
Number of babies who required extracorporeal membrane oxygenation (ECMO)
Description
the number of babies who required ECMO will be compared amongst the groups
Time Frame
up to one year
Title
Number of days on mechanical ventilation
Description
the number of days each baby required intubation and mechanical ventilation by any type will be compared amongst the groups
Time Frame
up to one year

10. Eligibility

Sex
All
Maximum Age & Unit of Time
24 Hours
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Admitted to either the University of Utah and/or Primary Children's Hospital NICU within 24 hours of birth Requiring mechanical ventilation Umbilical arterial line or peripheral arterial line in place Obtained signed consent Infant is ≤ 24 hours of age Exclusion Criteria: Severe anomaly Chromosomal abnormalities Major congenital anomalies, including cardiac, central nervous system and syndromes Post-natal diagnosis > 24 hours of life Unable to obtain consent for participation Unable to randomize within 24 hours of life
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michelle Yang, MD
Phone
801-581-7052
Email
michelle.yang@hsc.utah.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Carrie Rau
Phone
801-213-3360
Email
carrie.rau@hsc.utah.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michelle Yang, MD
Organizational Affiliation
University of Utah
Official's Role
Principal Investigator
Facility Information:
Facility Name
Primary Children's Hospital
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84113
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michelle Yang, MD
Phone
801-581-7052
Email
michelle.yang@hsc.utah.edu
First Name & Middle Initial & Last Name & Degree
Kimberlee Weaver-Lewis, RN
Phone
801-507-7675
Email
kimberlee.weaverlewis@imail.org
First Name & Middle Initial & Last Name & Degree
Michelle Yang, MD
Facility Name
University Hospital
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michelle Yang, MD
Phone
801-581-7052
Email
michell.yang@hsc.utah.edu
First Name & Middle Initial & Last Name & Degree
Carrie Rau, RN
Phone
801-213-3360
Email
carrie.rau@hsc.utah.edu
First Name & Middle Initial & Last Name & Degree
Michelle Yang, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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

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