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Hyperpolarized 129Xe MR Lung Imaging in Infants

This study is looking at a new way to image infant lungs using a special type of MRI with an inhaled gas called 129Xe. This method aims to provide clear images of lung problems like pneumonia or respiratory distress syndrome (RDS) without using radiation, which is a concern with X-rays and CT scans. Researchers want to see how well this imaging technique can detect lung ventilation defects in infants up to 6 months old. You might be able to join if your baby is in the NICU, is stable, and is on a small amount of oxygen. The study is currently unclear on its recruitment status.

Study design
This is an interventional study planning to enroll 12 infants. It is not specified if it is randomized or blinded.
What's involved
Participants will undergo an MRI scan using inhaled 129Xe. The primary measurement, ventilation defect percentage, will be taken at 1 day.
Compensation
Not stated in the trial record.
Follow-up
The primary outcome, ventilation defect percentage, is measured at 1 day after the intervention.

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NCT04995562

Use of Hyperpolarized 129Xe MR Lung Imaging in Infants

Recruiting
PHASE4Up to 6InterventionalDiagnostic
Children's Hospital Medical Center, Cincinnati
~12 participants
Updated 2026-01-07 on ClinicalTrials.gov
What's tested:129Xe

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Ventilation defect percentage (VDP)
Measured over 1 day

Conditions

Lungs; Developmental Disorder

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Bronchopulmonary DysplasiaCongenital Diaphragmatic HerniaPneumoniaPulmonary HypertensionRespiratory Distress Syndrome

Where it's being run

1 sites across 1 states
Ohio1

Study leadership

  • Jason Woods, PhD · PRINCIPAL_INVESTIGATOR · Children's Hospital Medical Center, Cincinnati

Who to contact

Megan Schmitt, RN
[email protected]
(513) 636-9348
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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
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
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

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
Infant size not compatible with NICU MRI scanner (\~\>4.5kg).

What this trial measures

  • Ventilation defect percentage (VDP)1 day

    To calculate the percentage of the lung that is ventilated with 129Xe gas. This is an indicator of lung ventilation. The lung function outcome will be measured using hyperpolarized 129Xe MRI, wherein hyperpolarized 129Xe is inhaled and its distribution is imaged within the lungs. Different MRI pulse sequences are used to obtain different functional information about the lungs. VDP will be assessed using a 2D spoiled gradient echo sequence.