Actively Recruiting

Phase 4
Age: 0 - 6Months
All Genders
NCT04995562

Use of Hyperpolarized 129Xe MR Lung Imaging in Infants

Led by Children's Hospital Medical Center, Cincinnati · Updated on 2026-01-07

12

Participants Needed

1

Research Sites

416 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Abnormalities of the lungs are common in newborns and can include aspiration or infectious pneumonia, respiratory distress syndrome (RDS), bronchopulmonary dysplasia (BPD), pulmonary hypertension (PH), congenital diaphragmatic hernia (CDH), and other abnormalities of lung development. Diagnostic radiography is commonly used in this population to differentiate diagnosis and to assess changes after treatment. While X-ray and CT provide quality imaging, they also expose infants to ionizing radiation. MR imaging offers a safe, non-ionizing alternative. However, imaging lungs via 1H MR is intrinsically difficult due to multiple air-tissue interfaces within the lungs causing local gradients and severe magnetic field susceptibility, which leads to an exceedingly short effective transverse relaxation time (T2\*). Additionally, the lungs have low proton density, which along with the short T2\* results in low signal to noise ratio, and the physiological motion caused by respiration and cardiac pulsation further reduces lung signal. The development of more powerful hardware, along with faster MRI techniques, has enabled detailed noninvasive 1H MR imaging of pulmonary tissues. Additionally, the development of inhaled hyperpolarized gas MRI has led to breakthroughs in the ability to visualize and quantify regional ventilation and alveolar size.

CONDITIONS

Official Title

Use of Hyperpolarized 129Xe MR Lung Imaging in Infants

Who Can Participate

Age: 0 - 6Months
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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 to 6 months
  • NICU patient on oxygen with a nasal cannula (2 liters per minute or less) with unchanged supplemental oxygen for at least 24 hours
  • Maintaining oxygen saturation above 88% on nasal oxygen
  • NICU patient requiring higher respiratory support such as high flow nasal cannula above 2 liters per minute, CPAP, or RAM cannula with oxygen unchanged for at least 24 hours and FiO2 less than 50%
  • Maintaining oxygen saturation above 88% on nasal oxygen
Not Eligible

You will not qualify if you...

  • General anesthesia within 24 hours prior to MRI or 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
  • Suspected muscular dystrophy or neurologic disorder affecting lung development
  • Significant genetic or chromosomal abnormalities affecting 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 respiratory support (FiO2 greater than 50% or invasive ventilation)
  • Standard MRI exclusion criteria such as incompatible support or implant equipment
  • Infant size not compatible with NICU MRI scanner (approximately over 4.5 kg)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Megan Schmitt

Cincinnati, Ohio, United States, 45229

Actively Recruiting

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Research Team

M

Megan Schmitt, RN

CONTACT

C

Carrie Stevens

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

DIAGNOSTIC

Number of Arms

2

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