Congenital Diaphragmatic Hernia
Conditions
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.
Interventions
DEVICEHigh 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.
DEVICEHigh 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.
Sponsors
University of Utah
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
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
Eligibility
Sex/Gender
ALL
Age
No minimum to 24 Hours
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of days on mechanical ventilation | up to one year | the number of days each baby required intubation and mechanical ventilation by any type will be compared amongst the groups |
| Number of babies who required extracorporeal membrane oxygenation (ECMO) | up to one year | the number of babies who required ECMO will be compared amongst the groups |
| Number of babies who survive to discharge | up to one year | the number of babies who survive and are discharged will be compared amongst the groups |
Countries
United States
Contacts
Primary ContactMichelle Yang, MD
Backup ContactCarrie Rau
Outcome results
None listed