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MRI in BPD Subjects

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ClinicalTrials.gov Identifier: NCT03657693
Recruitment Status : Unknown
Verified January 2020 by Children's Hospital Medical Center, Cincinnati.
Recruitment status was:  Recruiting
First Posted : September 5, 2018
Last Update Posted : January 23, 2020
Sponsor:
Information provided by (Responsible Party):
Children's Hospital Medical Center, Cincinnati

Study Description
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Brief Summary:
The investigators are wanting to learn more about early development of the lungs and to help them better understand prematurity and the development of a breathing disorder call BPD (Bronchopulmonary Dysplasia)

Condition or disease Intervention/treatment
Bronchopulmonary Dysplasia Diagnostic Test: NICU MRI Diagnostic Test: Polysomnography

Detailed Description:

This is an observational case study involving up to three MRI visits. The first MRI will be complete after the infant's clinical initial evaluation. The second image will be obtained approximately 1 month later and the third MRI will be complete prior to discharge. Infants will be imaged at various ages, based up their initial evaluation. The investigators will collect urine and obtain clinically collected remnant blood around time of MRI, tracheal/endotracheal aspirate at time of the MRI when available and BAL samples as clinically available. MRI findings will be correlated with laboratory findings and outcomes from the medical record, and a research database will be built for the data. The investigators will also obtain a one-time MRI visit in non-BPD NICU patients to acquire data related to normal vasculature and pulmonary alveolar development.

Sub-study 1: Inpatient polysomnography Patients with the same inclusion/exclusion criteria as reported below will be approached for a brief inpatient polysomnogram. The population will include patients with and without BPD. The polysomnography (PSG) will be performed in the NICU within 1 week from the MRI that is obtained prior to discharge.

Study Design
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Study Type : Observational
Estimated Enrollment : 160 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: MRI for Quantitative Measurement of Pulmonary Growth and Development in Term and Extremely Pre-Term Babies in the BPD Center of Excellence
Actual Study Start Date : May 4, 2018
Estimated Primary Completion Date : June 1, 2021
Estimated Study Completion Date : December 1, 2021

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
BPD
Infants born premature requiring oxygen
 Diagnostic Test: NICU MRI
MRI device that is not FDA approved.

Diagnostic Test: Polysomnography
Polysomnography to better determine obstruction index in the airway.
Controls Diagnostic Test: NICU MRI
MRI device that is not FDA approved.

Diagnostic Test: Polysomnography
Polysomnography to better determine obstruction index in the airway.


Outcome Measures
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Primary Outcome Measures :
  1. Anatomic phenotypes using MRI [ Time Frame: baseline ]
    Investigate parenchymal and vascular structures, regional cardiopulmonary function, and dynamic airway collapse in BPD infants during quiet unsedated breathing.


Secondary Outcome Measures :
  1. Polysomnography [ Time Frame: within a week of baseline MRI ]
    Determine the correlation between upper airway MRI and the obstruction index in the polysomnography.


Other Outcome Measures:
  1. Change in the anatomic phenotype using MRI [ Time Frame: 1 month post baseline and discharge from NICU ]
    Compare the parenchymal reader scoring, cardiac analysis, and airway scoring over the span of the BPD infant's time in the NICU.


Biospecimen Retention:   Samples Without DNA
Urine and remnant blood and BAL samples

Eligibility Criteria
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Ages Eligible for Study:   up to 4 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Bronchopulmonary Dysplasia (BPD)
Criteria

Inclusion Criteria:

  • any term age NICU patient

Exclusion Criteria:

  • - ECMO,
  • Evidence of congenital diseases that may affect lung development, such as congenital diaphragmatic hernia,
  • Suspected muscular dystrophy or neurologic disorder that may affect lung development.
  • Significant genetic or chromosomal abnormalities that may affect lung development
  • Evidence of any respiratory infection at the time of imaging (imaging may be rescheduled for a common viral infection such as a cold).
  • Standard MRI exclusion criteria as set forth by the CCHMC Department of Radiology. This includes any contraindications from tracheostomy tubes that are not MR compatible.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03657693


Contacts
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Contact: Priyanka Desirazu (513)803-4781 priyanka.desirazu@cchmc.org

Locations
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United States, Ohio
Cincinnati Children's Hospital Medical Center Recruiting
Cincinnati, Ohio, United States, 45229
Contact: Priyanka Desirazu    513-803-4781    priyanka.desirazu@cchmc.org   
Principal Investigator: Jason Woods, Ph.D.         
Sponsors and Collaborators
Children's Hospital Medical Center, Cincinnati
Investigators
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Principal Investigator: Jason Woods, PhD Children's Hospital Medical Center, Cincinnati
More Information
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Responsible Party: Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier: NCT03657693    
Other Study ID Numbers: CIN_BPD_COE_001
First Posted: September 5, 2018    Key Record Dates
Last Update Posted: January 23, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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Bronchopulmonary Dysplasia
Ventilator-Induced Lung Injury
Lung Injury
Lung Diseases
 Respiratory Tract Diseases
Infant, Premature, Diseases
Infant, Newborn, Diseases