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

Congenital Diaphragmatic Hernia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04774848
• Other study ID #: 133683
• Status: Recruiting
• Phase: N/A
• Start date: December 30, 2020
• Est. completion date: February 28, 2025

Study information

• Verified date: May 2024
• Source: University of Utah
• Contact: Michelle Yang, MD
• Phone: 801-581-7052
• Email: michelle.yang[@]hsc.utah.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: February 28, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 24 Hours

Eligibility

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

Related Conditions & MeSH terms

• Congenital Diaphragmatic Hernia
• Hernia
• Hernia, Diaphragmatic
• Hernias, Diaphragmatic, Congenital

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Primary Children's Hospital	Salt Lake City	Utah
United States	University Hospital	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
University of Utah

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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