Characterization of Fetal Lung With Quantitative Ultrasound
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Number of Participants Enrolled as a Proxy for the Feasibility of bQUS to collect technically viable data
研究概览
简要总结
The purpose of the study is to show if it's possible to use a special kind of ultrasound called backscatter quantitative ultrasound (bQUS) to check on a baby's lungs when the mother is 36 weeks pregnant. 16 participants will be on study for a single 30 minute ultrasound between 32 and 36 weeks of pregnancy.
详细描述
Primary Objective:
- Demonstrate the feasibility of performing bQUS analysis on ultrasound echo signals acquired of the fetal lung acquired with clinical ultrasound scanners during third -trimester ultrasound scans
Secondary Objectives:
- Design and implement a protocol to acquire non-processed (raw) echo signals from a commercial ultrasound scanner necessary to perform bQUS at the UPH-Meriter Center for Perinatal Care (CPC).
- Quantify the populational variance of quantitative features extracted from bQUS applied to ultrasound data collected from third trimester ultrasound scans of the fetal lung.
The study will be divided into two phases: (i) feasibility phase and (2) hypothesis-testing phase recruitment phase. Phase 1 will provide evidence of the technical viability of data acquisition at UPH-Meriter CPC and will involve 5 participants. Technical challenges will be discussed with the research team and the supporting vendor (GE) to decide whether the technique is viable to move forward. In case the decision is favorable, recruitment will continue to complete 16 participants to estimate the populational variance of the quantitative features. If the decision is not favorable due to technical complications, the study will be terminated.
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
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Pregnant females ages 18 to 45 years old with singleton pregnancy, live fetus, gestational age between 32.1 and 36.7 weeks, not in labor, scheduled for routine ultrasound growth evaluation.
- •Gestational age determined by the date of the last menses, and confirmed by measurement of the crown-rump-length on transabdominal ultrasound.
排除标准
- •Subjects unable to consent
- •Active Labor
- •Fetal malformations of the lungs
- •Prescription of corticosteroids prior to ultrasound evaluation
- •Pre-gestation or gestational diabetes mellitus
- •Low English proficiency, needing an interpreter
研究组 & 干预措施
36 Weeks Pregnant
干预措施: Backscatter Quantitative Ultrasound (Device)
结局指标
主要结局
Number of Participants Enrolled as a Proxy for the Feasibility of bQUS to collect technically viable data
时间窗: data collected over a single study visit (up to 30 minutes)
Phase 1 will provide evidence of the technical viability of data acquisition at the UPH-Meriter CPC and will involve 5 participants. Technical challenges will be discussed with the research team and the supporting vendor (GE) to decide whether the technique is viable to move forward. In case the decision is favorable, recruitment will continue to complete 16 participants to estimate the populational variance of the quantitative features. If the decision is not favorable due to technical complications, the study will be terminated.
次要结局
- Population Variance in Fetal Lung Microstructure(data collected over a single study visit (up to 30 minutes))
- Population Variance in Fetal Lung Microstructure(data collected over a single study visit (up to 30 minutes))