New Gas-Based MRI could replace X-Rays for baby lungs
NCT ID NCT04995562
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests a new way to take pictures of babies' lungs using MRI with a special inhaled gas (129Xe) instead of X-rays or CT scans, which use radiation. The goal is to safely see how well the lungs are working in infants with breathing problems. About 12 infants in the NICU will be enrolled to measure lung ventilation and structure.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- inhaled hyperpolarized 129Xe gas
- What this could lead to
- If successful, this could provide a safer, radiation-free way to diagnose and monitor lung problems in newborns.
- What could go wrong
- This is a very small early-phase study (12 infants) focused on imaging feasibility, not treatment. The gas is inhaled and may not work well in all infants.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 12 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2020
- Expected to finish
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May 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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Up to 6 months
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
All Cohorts Inclusion Criteria: * Male or female * Any age NICU inpatient who is clinically stable and with adequate temperature control to tolerate MRI as determined by the primary clinical team Cohort 1 * Age 0 - 6 months * NICU patient on oxygen with a nasal cannula (≤ 2L per minute) (unchanged - supplemental O2 for minimum 24 hours) * Maintaining SpO2 \> 88% on nasal O2 Cohort 2 * Age 0 - 6 months * NICU patient who requires a slightly higher level of respiratory support (with High Flow Nasal Cannula \> 2L per minute, CPAP, or RAM cannula and O2 unchanged for minimum 24 hours), with FiO2 \< 50%. * Maintaining SpO2 \> 88% on nasal O2 Exclusion Criteria: * General anesthesia within 24 hours prior to MRI or other sedation (e.g. morphine, Versed, fentanyl) within the last 4 hours. * Extracorporeal membrane oxygenation (ECMO) support * Evidence of any respiratory infection within 1 week of testing (imaging may be rescheduled for a common viral infection such as a cold). * Suspected muscular dystrophy or neurologic disorder that may affect lung development. * Significant genetic or chromosomal abnormalities that may affect lung development * Congenital heart disease * Uncontrolled atrial or ventricular arrhythmia * Open surgical wounds * Need for inotropic support * Need for vasodilator agents * Need for high level of respiratory support (i.e. FiO2 \>50%, and/or higher respiratory support than listed in Cohort 2 Inclusion Criteria, such as invasive ventilation). * Standard MRI exclusion criteria as set forth by the CCHMC Department of Radiology (e.g., contraindicated support/implant equipment that is not MR compatible). * Infant size not compatible with NICU MRI scanner (\~\>4.5kg).
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Megan Schmitt
RECRUITINGCincinnati, Ohio, 45229, United States