Use of Hyperpolarized 129Xe MR Lung Imaging in Infants

• Status: Recruiting
• Trial end date: 2023-04-30
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Children's Hospital Medical Center, Cincinnati

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).