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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 day
Awards & highlights
Study 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.Check my eligibility
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.See study design
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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I am a stable NICU patient who can safely undergo an MRI.
Select...
My baby needs extra help to breathe but not too much oxygen.
Select...
My oxygen levels stay above 88% with nasal oxygen support.
Select...
My baby is in the NICU and has been on a low-flow nasal cannula for over 24 hours.
Select...
I am under 6 months old.
Select...
I am either male or female.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 day
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 day
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Ventilation defect percentage (VDP)
Secondary outcome measures
Apparent diffusion coefficient (ADC)
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
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Who is running the clinical trial?
Children's Hospital Medical Center, CincinnatiLead Sponsor
814 Previous Clinical Trials
6,531,569 Total Patients Enrolled
3 Trials studying Bronchopulmonary Dysplasia
199 Patients Enrolled for Bronchopulmonary Dysplasia
Jason Woods, PhDPrincipal InvestigatorChildren's Hospital Medical Center, Cincinnati
8 Previous Clinical Trials
497 Total Patients Enrolled
1 Trials studying Bronchopulmonary Dysplasia
160 Patients Enrolled for Bronchopulmonary Dysplasia
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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 oxygen levels stay above 88% with nasal oxygen support.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 under 6 months old.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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the uppermost capacity of participants for this clinical experiment?
"Correct. The entry on clinicaltrials.gov verifies that this study, which was initiated on May 6th 2020 is actively enrolling participants. Specifically, 12 patients are needed to be recruited from 1 medical centre."
Answered by AI
Are there any vacancies within this research program for participants?
"According to clinicaltrials.gov, the enrollment for this trial is presently underway. The original listing was published on May 6th 2020 and modified last on July 29th 2021."
Answered by AI
What risks does exposure to 129Xe pose to human health?
"There is an abundance of data substantiating 129Xe's safety, so it has earned a score of 3."
Answered by AI
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