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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to one year
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
My baby is less than or exactly 24 hours old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to one year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to one year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Oxygenation Index (OI) at 24 hours of age
Secondary outcome measures
Number of babies who received inhaled nitric oxide (iNO)
PF ratio (PaO2/FiO2) measurements
PF-PCO2 (PaO2/FiO2-PaCO2) measurements
+1 moreOther outcome measures
Number of babies who required extracorporeal membrane oxygenation (ECMO)
Number of babies who survive to discharge
Number of days on mechanical ventilation
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.
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Who is running the clinical trial?
University of UtahLead Sponsor
1,099 Previous Clinical Trials
1,778,639 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.
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have significant birth defects or conditions affecting the heart, brain, or overall development.You have a serious abnormality.You need to use a machine to help you breathe.My condition was diagnosed more than 24 hours after birth.This criterion does not apply to me as a patient.My baby is less than or exactly 24 hours old.My condition involves chromosomal abnormalities.
Research Study Groups:
This trial has the following groups:- Group 1: High Frequency Oscillatory Ventilation (HFOV) without intrathoracic liver
- Group 2: High Frequency Oscillatory Ventilation (HFOV) with intrathoracic liver
- Group 3: High Frequency Jet Ventilation (HFJV) with intrathoracic liver
- Group 4: High Frequency Jet Ventilation (HFJV) without intrathoracic liver
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this research endeavor currently seeking new participants?
"Affirmative, the information posted to clinicaltrials.gov suggests that this trial is open for recruitment at present. It was inaugurated on December 30th 2020 and most recently updated on September 27th 2022, seeking 50 patients from two distinct medical centres."
Answered by AI
How many participants have been accepted to this clinical exploration?
"Indeed, the information presented on clinicaltrials.gov attests to this medical trial being currently in search of participants; it was first posted online at December 30th 2020 and recently updated September 27th 2022. The study requires 50 patients from two research centres."
Answered by AI
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