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Gas
Hyperpolarized Xenon MRI for Infant Lung Imaging
Phase 4
Recruiting
Led By Jason Woods, PhD
Research Sponsored by Children's Hospital Medical Center, Cincinnati
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Maintaining SpO2 > 88% on nasal O2
Age 0 - 6 months
Must not have
Need for vasodilator agents
Uncontrolled atrial or ventricular arrhythmia
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 day
Awards & highlights
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial
Summary
This trial found that MR imaging is a safe, non-invasive way to image lungs, which is difficult to do because the lungs have low proton density and short T2*.
Who is the study for?
This trial is for infants aged 0-6 months in the NICU who need a bit more breathing support but are stable enough to undergo MRI, without severe heart disease, genetic issues affecting lung development, or recent surgery. They should not have had anesthesia recently and must fit into the NICU MRI scanner.
What is being tested?
The study tests hyperpolarized Xenon (129Xe) as an MR imaging agent to visualize infant lung function safely without ionizing radiation. It aims to improve diagnosis and treatment assessment for various lung conditions in newborns.
What are the potential side effects?
Since this trial involves imaging with hyperpolarized gas and no drugs or invasive procedures, there are minimal expected side effects. The primary concern would be discomfort from the MRI process itself.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My oxygen levels stay above 88% with nasal oxygen support.
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I am under 6 months old.
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My baby needs extra help to breathe but not too much oxygen.
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My baby is in the NICU and has been on a low-flow nasal cannula for over 24 hours.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I need medication to widen my blood vessels.
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I have an irregular heartbeat that is not under control.
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I have genetic issues that could affect my lung development.
Select...
I require a high level of help with my breathing.
Select...
I need medication to help my heart pump more effectively.
Select...
I currently have open surgical wounds.
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I was born with a heart condition.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 day
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 day
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Ventilation defect percentage (VDP)
Secondary study objectives
Apparent diffusion coefficient (ADC)
Awards & Highlights
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Oxygen with nasal cannulaExperimental Treatment1 Intervention
6 infants on oxygen with nasal cannula
Group II: HFNC, CPAP, or RAM cannulaExperimental Treatment1 Intervention
6 infants currently requiring respiratory support with high flow nasal cannula (HFNC), continuous positive airway pressure (CPAP) or RAM cannula
Find a Location
Who is running the clinical trial?
Children's Hospital Medical Center, CincinnatiLead Sponsor
839 Previous Clinical Trials
6,565,591 Total Patients Enrolled
17 Trials studying Asthma
2,622 Patients Enrolled for Asthma
Jason Woods, PhDPrincipal InvestigatorChildren's Hospital Medical Center, Cincinnati
8 Previous Clinical Trials
497 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I need medication to widen my blood vessels.My oxygen levels stay above 88% with nasal oxygen support.I have an irregular heartbeat that is not under control.I have genetic issues that could affect my lung development.I am under 6 months old.I might have a muscle or nerve disorder affecting my lungs.I haven't had a respiratory infection like a cold in the last week.I am a stable NICU patient who can safely undergo an MRI.I require a high level of help with my breathing.My baby needs extra help to breathe but not too much oxygen.My baby is in the NICU and has been on a low-flow nasal cannula for over 24 hours.I need medication to help my heart pump more effectively.I am either male or female.I currently have open surgical wounds.I was born with a heart condition.Your baby is too big to fit in the MRI scanner in the neonatal intensive care unit (NICU).You are currently on ECMO support.I haven't had general anesthesia in the last 24 hours or sedation in the last 4 hours.
Research Study Groups:
This trial has the following groups:- Group 1: Oxygen with nasal cannula
- Group 2: HFNC, CPAP, or RAM cannula
Awards:
This trial has 3 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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.