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High Frequency Ventilation for Diaphragmatic Hernia

N/A
Recruiting
Led By Michelle Yang, MD
Research Sponsored by University of Utah
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Infant is ≤ 24 hours of age
Be younger than 18 years old
Must not have
Post-natal diagnosis > 24 hours of life
Unable to randomize within 24 hours of life
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to one year
Awards & highlights
No Placebo-Only Group

Summary

This trial is investigating whether high frequency jet ventilation or high frequency oscillatory ventilation is more effective in treating congenital diaphragmatic hernia in neonates.

Who is the study for?
This trial is for newborns with congenital diaphragmatic hernia who need mechanical ventilation and are admitted to specific NICUs within 24 hours of birth. They must have an arterial line in place. Babies with severe or major anomalies, chromosomal abnormalities, or diagnosed after 24 hours aren't eligible.
What is being tested?
The study compares two types of ventilator support for newborns: High Frequency Jet Ventilation (HFJV) and High Frequency Oscillatory Ventilation (HFOV). Newborns will be randomly assigned to one of these methods right after birth or upon NICU admission.
What are the potential side effects?
Potential side effects may include issues related to oxygenation, breathing difficulties, and changes in blood circulation due to the different ways each ventilator supports the infants' breathing.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My baby is less than or exactly 24 hours old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
My condition was diagnosed more than 24 hours after birth.
Select...
This criterion does not apply to me as a patient.
Select...
My condition involves chromosomal abnormalities.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to one year
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to one year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Oxygenation Index (OI) at 24 hours of age
Secondary study objectives
Number of babies who received inhaled nitric oxide (iNO)
PF ratio (PaO2/FiO2) measurements
PF-PCO2 (PaO2/FiO2-PaCO2) measurements
+1 more
Other study objectives
Number of babies who required extracorporeal membrane oxygenation (ECMO)
Number of babies who survive to discharge
Number of days on mechanical ventilation

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups
Active Control
Group I: High Frequency Oscillatory Ventilation (HFOV) without intrathoracic liverActive Control1 Intervention
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.
Group II: High Frequency Oscillatory Ventilation (HFOV) with intrathoracic liverActive Control1 Intervention
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.
Group III: High Frequency Jet Ventilation (HFJV) with intrathoracic liverActive Control1 Intervention
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.
Group IV: High Frequency Jet Ventilation (HFJV) without intrathoracic liverActive Control1 Intervention
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.

Find a Location

Who is running the clinical trial?

University of UtahLead Sponsor
1,147 Previous Clinical Trials
1,699,571 Total Patients Enrolled
Michelle Yang, MD3.118 ReviewsPrincipal Investigator - University of Utah
University of Utah
5Patient Review
My husband's cataract surgery was further complicated by his Glaucoma. Dr. Yang referred him to an excellent surgeon in El Paso. The surgery was successful and we are very grateful for her knowledge and assistance. Her staff is always helpful and courteous.

Media Library

High Frequency Jet Ventilator Clinical Trial Eligibility Overview. Trial Name: NCT04774848 — N/A
Congenital Diaphragmatic Hernia Research Study Groups: High Frequency Oscillatory Ventilation (HFOV) without intrathoracic liver, High Frequency Oscillatory Ventilation (HFOV) with intrathoracic liver, High Frequency Jet Ventilation (HFJV) with intrathoracic liver, High Frequency Jet Ventilation (HFJV) without intrathoracic liver
Congenital Diaphragmatic Hernia Clinical Trial 2023: High Frequency Jet Ventilator Highlights & Side Effects. Trial Name: NCT04774848 — N/A
High Frequency Jet Ventilator 2023 Treatment Timeline for Medical Study. Trial Name: NCT04774848 — N/A
~0 spots leftby Dec 2024
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