[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT03657693":3,"trial-entities:NCT03657693":94,"trial-summary:NCT03657693":97},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":24,"interventions":27,"primary_outcomes":39,"secondary_outcomes":44,"sex":48,"minimum_age":22,"maximum_age":49,"healthy_volunteers":15,"eligibility_criteria":50,"std_ages":60,"locations":62,"central_contacts":84,"overall_officials":89,"references":92,"see_also_links":93},"NCT03657693","CIN_BPD_COE_001","MRI in BPD Subjects","MRI for Quantitative Measurement of Pulmonary Growth and Development in Term and Extremely Pre-Term Babies in the BPD Center of Excellence","RECRUITING","2030-12-31","2026-01","2026-01-07","2018-05-04","Children's Hospital Medical Center, Cincinnati","OTHER",true,"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)","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\u002Fendotracheal 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.\n\nSub-study 1: Inpatient polysomnography Patients with the same inclusion\u002Fexclusion 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.",[19],"Bronchopulmonary Dysplasia",[],"OBSERVATIONAL",null,[],{"count":25,"type":26},160,"ESTIMATED",[28,35],{"type":29,"name":30,"description":31,"armGroupLabels":32},"DIAGNOSTIC_TEST","NICU MRI","MRI device that is not FDA approved.",[33,34],"BPD","Controls",{"type":29,"name":36,"description":37,"armGroupLabels":38},"Polysomnography","Polysomnography to better determine obstruction index in the airway.",[33,34],[40],{"measure":41,"description":42,"timeFrame":43},"Anatomic phenotypes using MRI","Investigate parenchymal and vascular structures, regional cardiopulmonary function, and dynamic airway collapse in BPD infants during quiet unsedated breathing.","baseline",[45],{"measure":36,"description":46,"timeFrame":47},"Determine the correlation between upper airway MRI and the obstruction index in the polysomnography.","within a week of baseline MRI","ALL","4 Months",{"inclusion":51,"exclusion":53,"raw_text":59},[52],"any term age NICU patient",[54,55,56,57,58],"\\- 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).","Inclusion Criteria:\n\n* any term age NICU patient\n\nExclusion Criteria:\n\n* \\- ECMO,\n* Evidence of congenital diseases that may affect lung development, such as congenital diaphragmatic hernia,\n* Suspected muscular dystrophy or neurologic disorder that may affect lung development.\n* Significant genetic or chromosomal abnormalities that may affect lung development\n* Evidence of any respiratory infection at the time of imaging (imaging may be rescheduled for a common viral infection such as a cold).\n* 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.",[61],"CHILD",[63],{"facility":64,"status":8,"city":65,"state":66,"zip":67,"country":68,"contacts":69,"geoPoint":81},"Megan Schmitt","Cincinnati","Ohio","45229","United States",[70,74,78],{"name":64,"role":71,"phone":72,"email":73},"CONTACT","5136369348","Megan.Schmitt@cchmc.org",{"name":75,"role":71,"phone":76,"email":77},"Ashley Bordon","5136360143","Ashley.Bordon@cchmc.org",{"name":79,"role":80},"Jason Woods, Ph.D.","PRINCIPAL_INVESTIGATOR",{"lat":82,"lon":83},39.12711,-84.51439,[85,87],{"name":64,"role":71,"phone":86,"email":73},"(513) 636-9348",{"name":88,"role":71,"phone":76,"email":77},"Ashley Bordon, MS",[90],{"name":91,"affiliation":13,"role":80},"Jason Woods, PhD",[],[],{"nct_id":4,"conditions":95,"biomarkers":96},[19],[],{"nct_id":4,"found":15,"summary":98,"prompt_version":108},{"design":99,"status":100,"heading":101,"summary":102,"follow_up":103,"word_count":104,"commitments":105,"compensation":106,"drugs_mentioned":107},"This is an observational study involving 160 participants. It is not a randomized trial and does not specify a phase.","completed","Observational MRI Study in Bronchopulmonary Dysplasia (BPD)","This study is looking at how the lungs develop in babies, especially those with Bronchopulmonary Dysplasia (BPD), a breathing problem common in premature infants. Researchers will use an MRI device (a machine that uses magnets and radio waves to create detailed pictures of organs and structures inside the body) to take images of the lungs. They will also use Polysomnography (a sleep study that records brain waves, oxygen levels, heart rate, and breathing during sleep) to understand breathing issues. The main goal is to see how lung anatomy looks on MRI. This study is for NICU patients up to 4 months old, but excludes those with certain other health conditions. The study is currently unclear on its recruitment status and plans to enroll 160 participants.","Anatomic phenotypes using MRI are measured at baseline, but no further follow-up duration is specified.",125,"Participants will have up to three MRI visits, with the first after initial evaluation, the second about one month later, and the third before discharge. Some participants may also have a brief inpatient polysomnogram in the NICU.","Not stated in the trial record.",[36],"v2"]