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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:

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My condition was diagnosed more than 24 hours after birth.

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This criterion does not apply to me as a patient.

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My condition involves chromosomal abnormalities.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to one year

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.

0 / 4Eligibility criteria met

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Who is running the clinical trial?

University of UtahLead Sponsor

1,141 Previous Clinical Trials

1,697,744 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.