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Use of Hyperpolarized 129Xe MR Lung Imaging in Infants
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:
🦠 Lungs; Developmental Disorder
🗓️ Study Start (Actual) 6 May 2020
🗓️ Primary Completion (Estimated) 30 April 2025
✅ Study Completion (Estimated) 30 April 2025
👥 Enrollment (Estimated) 12
🔬 Study Type INTERVENTIONAL
📊 Phase PHASE4
Locations:
📍 Cincinnati, Ohio, United States

📋 Eligibility Criteria

Description

  • 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).
Ages Eligible for Study: N/A to 6 Months (CHILD)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 12 April 2021
  • First Submitted that Met QC Criteria 29 July 2021
  • First Posted 9 August 2021

Study Record Updates

  • Last Update Submitted that Met QC Criteria 23 October 2023
  • Last Update Posted 25 October 2023
  • Last Verified October 2023
I'm interested ...!!