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

Not Applicable

Recruiting

• Conditions: Congenital Diaphragmatic Hernia
• Interventions: Device: High Frequency Jet Ventilator; Device: High Frequency Oscillatory Ventilator

• Registration Number: NCT04774848
• Lead Sponsor: University of Utah

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-12-30
• Study First Submitted: 2021-02-24
• Study First Submitted QC: 2021-02-24
• Study First Posted: 2021-03-01
• Status Verified: 2025-01
• Last Update Submitted: 2025-04-01
• Last Update Posted: 2025-04-04
• Primary Completion: 2025-06-30
• Study Completion: 2025-08-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High Frequency Jet Ventilation (HFJV) without intrathoracic liver	High Frequency Jet 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.
High Frequency Jet Ventilation (HFJV) with intrathoracic liver	High Frequency Jet Ventilator	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.
High Frequency Oscillatory Ventilation (HFOV) without intrathoracic liver	High Frequency Oscillatory Ventilator	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.
High Frequency Oscillatory Ventilation (HFOV) with intrathoracic liver	High Frequency Oscillatory 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.

Primary Outcome Measures

Name	Time	Method
Oxygenation Index (OI) at 24 hours of age	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

Name	Time	Method
PF ratio (PaO2/FiO2) measurements	up to one week	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	up to one week	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)	up to one week	the number of babies who received treatment of iNO will be compared amongst the different groups
PaCO2 measurements	up to one week	These measurements will be determined at multiple time points for the first week of life. These measurements will be compared between groups.

Trial Locations

Locations (2)

Primary Children's Hospital; 🇺🇸 Salt Lake City, Utah, United States

University Hospital; 🇺🇸 Salt Lake City, Utah, United States