Clinical trial NCT04774848: 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
Overall status: RECRUITING
Phase: NA
Conditions: Congenital Diaphragmatic Hernia
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2021-03-01
Enrollment: 50
Sex: ALL
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Oxygenation Index (OI) at 24 hours of age
timeFrame: 24 hours of age
Secondary outcomes:
measure: PF ratio (PaO2/FiO2) measurements
timeFrame: up to one week
measure: PF-PCO2 (PaO2/FiO2-PaCO2) measurements
timeFrame: up to one week
measure: PaCO2 measurements
timeFrame: up to one week
measure: Number of babies who received inhaled nitric oxide (iNO)
timeFrame: up to one week
Other outcomes:
measure: Number of babies who survive to discharge
timeFrame: up to one year
measure: Number of babies who required extracorporeal membrane oxygenation (ECMO)
timeFrame: up to one year
measure: Number of days on mechanical ventilation
timeFrame: up to one year
Locations:
city: Salt Lake City
country: United States
facility: Primary Children's Hospital
state: Utah
city: Salt Lake City
country: United States
facility: University Hospital
state: Utah
Study officials:
affiliation: University of Utah
name: Michelle Yang, MD
role: PRINCIPAL_INVESTIGATOR
References: