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

Utah System of Higher Education (USHE)

Status: Enrolling

Conditions: Congenital Diaphragmatic Hernia

Treatments: Device: High Frequency Oscillatory Ventilator; Device: High Frequency Jet Ventilator

Study type: Interventional

Funder types: Other

Identifiers

NCT04774848

133683

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: Under 24 hours old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 4 patient groups

High Frequency Jet Ventilation (HFJV) with intrathoracic liver

Active Comparator group

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.

Treatment:

Device: High Frequency Jet Ventilator

High Frequency Jet Ventilation (HFJV) without intrathoracic liver

Active Comparator group

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.

Treatment:

Device: High Frequency Jet Ventilator

High Frequency Oscillatory Ventilation (HFOV) with intrathoracic liver

Active Comparator group

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.

Treatment:

Device: High Frequency Oscillatory Ventilator

High Frequency Oscillatory Ventilation (HFOV) without intrathoracic liver

Active Comparator group

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.

Treatment:

Device: High Frequency Oscillatory Ventilator