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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Maximum Age: 1 day
Healthy Volunteers: f
View:

• 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

Locations
United States
Utah
Primary Children's Hospital
RECRUITING
Salt Lake City
University Hospital
RECRUITING
Salt Lake City
Contact Information
Primary
Michelle Yang, MD
michelle.yang@hsc.utah.edu
801-581-7052
Backup
Carrie Rau
carrie.rau@hsc.utah.edu
801-213-3360
Time Frame
Start Date: 2020-12-30
Estimated Completion Date: 2025-08-28
Participants
Target number of participants: 50
Treatments
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.
Sponsors
Leads: University of Utah

This content was sourced from clinicaltrials.gov