Hyperpolarized 129Xe MRI for lung imaging in infants

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the use of hyperpolarized xenon-129 MRI to safely image the lungs of infants in the neonatal intensive care unit (NICU). The study aims to assess lung abnormalities in newborns, which are common and can include conditions like respiratory distress syndrome and bronchopulmonary dysplasia. By utilizing a non-ionizing imaging technique, the trial seeks to provide a safer alternative to traditional X-ray and CT imaging methods. The approach involves inhaling a hypoxic gas mixture while closely monitoring the infants' oxygen levels during the MRI procedure.

Why it matters

Who can join: the full rules

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).

Where it's running

• Megan Schmitt
  Cincinnati, Ohio, United States Recruiting

Study contacts

• Principal investigator: Jason Woods, PhD — Children's Hospital Medical Center, Cincinnati
• Study coordinator: Megan Schmitt, RN
• Email: Megan.Schmitt@cchmc.org
• Phone: (513) 636-9348

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.