Use of Hyperpolarized 129Xe MR Lung Imaging in Infants

Who is this study for? Patients with Lung Developmental Disorder
What treatments are being studied? 129Xe
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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.

Eligibility
Participation Requirements
Sex: All
Maximum Age: 6 months
Healthy Volunteers: f
View:

• 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

Locations
United States
Ohio
Megan Schmitt
RECRUITING
Cincinnati
Contact Information
Primary
Megan Schmitt, RN
Megan.Schmitt@cchmc.org
(513) 636-9348
Backup
Carrie Stevens
carrie.stevens@cchmc.org
(513) 636-9973
Time Frame
Start Date: 2020-05-06
Estimated Completion Date: 2027-04-30
Participants
Target number of participants: 12
Treatments
Experimental: Oxygen with nasal cannula
6 infants on oxygen with nasal cannula
Experimental: HFNC, CPAP, or RAM cannula
6 infants currently requiring respiratory support with high flow nasal cannula (HFNC), continuous positive airway pressure (CPAP) or RAM cannula
Sponsors
Leads: Children's Hospital Medical Center, Cincinnati

This content was sourced from clinicaltrials.gov