Using MRI to study lung development in infants with Bronchopulmonary Dysplasia
MRI for Quantitative Measurement of Pulmonary Growth and Development in Term and Extremely Pre-Term Babies in the BPD Center of Excellence
This study is testing how MRI scans can help us understand lung development in premature infants with Bronchopulmonary Dysplasia by comparing them to infants without the condition.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 160 (estimated) |
| Ages | N/A to 4 Months |
| Sex | All |
| Sponsor | Children's Hospital Medical Center, Cincinnati Academic / other |
| Locations | 1 site (Cincinnati, Ohio) |
| Trial ID | NCT03657693 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate the early development of lungs in infants, particularly focusing on those diagnosed with Bronchopulmonary Dysplasia (BPD). Participants will undergo up to three MRI scans at different stages of their care in the NICU, alongside the collection of urine, blood, and respiratory samples. The study will correlate MRI findings with clinical outcomes and laboratory results to enhance understanding of lung development in premature infants. Additionally, a comparison group of non-BPD NICU patients will be included to gather data on normal lung development.
Who should consider this trial
Good fit: Ideal candidates include any term age NICU patients without significant congenital or respiratory conditions.
Not a fit: Patients with conditions such as ECMO, congenital diaphragmatic hernia, or significant respiratory infections at the time of imaging may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and management of lung development issues in premature infants, potentially reducing the incidence or severity of BPD.
How similar studies have performed: While this approach is observational and builds on existing knowledge, similar studies have shown promise in understanding lung development in premature infants.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Cincinnati, Ohio
- Megan Schmitt — Cincinnati, Ohio, United States (Recruiting)
Study contacts
- Principal investigator: Jason Woods, PhD — Children's Hospital Medical Center, Cincinnati
- Study coordinator: Megan Schmitt
- Email: Megan.Schmitt@cchmc.org
- Phone: (513) 636-9348
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.