Hyperpolarized 129Xe MRI for lung imaging in infants
Use of Hyperpolarized 129Xe MR Lung Imaging in Infants
This study tests a new type of MRI using a special gas to safely check the lungs of newborns in the NICU for common breathing problems.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 12 (estimated) |
| Ages | N/A to 6 Months |
| Sex | All |
| Sponsor | Children's Hospital Medical Center, Cincinnati Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Cincinnati, Ohio) |
| Trial ID | NCT04995562 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are clinically stable NICU infants aged 0 to 6 months who require supplemental oxygen.
Not a fit: Patients who have undergone general anesthesia or sedation within the last 24 hours or those on ECMO support may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a safer and more effective imaging method for diagnosing lung conditions in infants.
How similar studies have performed: Previous studies using hyperpolarized gases for lung imaging in older children and adults have shown promising results, indicating potential for success in this novel application for infants.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Cincinnati, Ohio
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.