MRI for Quantitative Measurement of Pulmonary Growth and Development in Term and Extremely Pre-Term Babies in the BPD Center of Excellence
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 160
- 试验地点
- 2
- 主要终点
- Anatomic phenotypes using MRI
研究概览
简要总结
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)
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 4 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •any term age NICU patient
排除标准
- •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.
研究组 & 干预措施
BPD
Infants born premature requiring oxygen
干预措施: NICU MRI (Diagnostic Test)
BPD
Infants born premature requiring oxygen
干预措施: Polysomnography (Diagnostic Test)
Controls
干预措施: NICU MRI (Diagnostic Test)
Controls
干预措施: Polysomnography (Diagnostic Test)
结局指标
主要结局
Anatomic phenotypes using MRI
时间窗: baseline
Investigate parenchymal and vascular structures, regional cardiopulmonary function, and dynamic airway collapse in BPD infants during quiet unsedated breathing.
次要结局
- Polysomnography(within a week of baseline MRI)