Bronchopulmonary DysplasiaNCT03657693
MRI in BPD Subjects
An observational study of Bronchopulmonary Dysplasia, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
Trial 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) Read more about this study
- Who is it for?
- Ages Up to 4 monthsHealthy volunteers can take part
- Conditions the study is for
- Bronchopulmonary Dysplasia
- What is being tested?
- NICU MRI and Polysomnography
- How many people
- 160 participants
- Where
- 1 siteUnited States
- Study dates
- 4 May 2018to 31 Dec 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 4 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: Bronchopulmonary Dysplasia (BPD)
Who may be able to join
- any term age NICU patient
Who cannot join
- - 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Megan Schmitt
Cincinnati, Ohio, 45229
Megan Schmitt, 5136369348, Megan.Schmitt@cchmc.org
Ashley Bordon, 5136360143, Ashley.Bordon@cchmc.org
About this study
Official title: MRI for Quantitative Measurement of Pulmonary Growth and Development in Term and Extremely Pre-Term Babies in the BPD Center of Excellence
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)
Read the 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.
- Conditions
- Bronchopulmonary Dysplasia
- Being tested
- NICU MRI, Polysomnography
- Medical subject headings
- Bronchopulmonary Dysplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NICU MRIDiagnostic test
MRI device that is not FDA approved.
PolysomnographyDiagnostic test
Polysomnography to better determine obstruction index in the airway.
| Study group | Role | What they receive |
|---|---|---|
| BPD | Infants born premature requiring oxygen Receives: Diagnostic Test: NICU MRI; Diagnostic Test: Polysomnography | |
| Controls | Not described Receives: Diagnostic Test: NICU MRI; Diagnostic Test: Polysomnography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anatomic phenotypes using MRI
Investigate parenchymal and vascular structures, regional cardiopulmonary function, and dynamic airway collapse in BPD infants during quiet unsedated breathing.
Measured: baseline
Secondary outcomes (1)
Polysomnography
Determine the correlation between upper airway MRI and the obstruction index in the polysomnography.
Measured: within a week of baseline MRI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2018
- Study start4 May 2018
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bronchopulmonary DysplasiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jason Woods, PhD, Principal investigator, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03657693
- Sponsor's protocol ID
- CIN_BPD_COE_001
- Status last verified
- Jan 2026
- First submitted
- 16 May 2018
- Last updated
- 7 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MRI for Quantitative Measurement of Pulmonary Growth and Development in Term and Extremely Pre-Term Babies in the BPD Center of Excellence
- ClinicalTrials.gov ID
- NCT03657693
- Acronym / sponsor ID
- CIN_BPD_COE_001
- Conditions
- Bronchopulmonary Dysplasia
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Study start
- 4 May 2018 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 5 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BPD | – | Diagnostic Test: NICU MRI, Diagnostic Test: PolysomnographyInfants born premature requiring oxygen |
| Controls | – | Diagnostic Test: NICU MRI, Diagnostic Test: Polysomnography |
Who may qualify
- Ages
- Up to 4 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Bronchopulmonary Dysplasia (BPD)
Key inclusion criteria (1 listed)
- any term age NICU patient
Key exclusion criteria (6 listed)
- - 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NICU MRIMRI device that is not FDA approved. | Diagnostic test | BPD, Controls |
| PolysomnographyPolysomnography to better determine obstruction index in the airway. | Diagnostic test | BPD, Controls |
Primary outcome
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.
1 secondary outcome
Polysomnography
Time frame: within a week of baseline MRI
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jason Woods, PhD principal investigator
Children's Hospital Medical Center, Cincinnati
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bronchopulmonary Dysplasia, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Megan Schmitt ((513) 636-9348, Megan.Schmitt@cchmc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anatomic phenotypes using MRI (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2026.