Assessment of Metabolic Bone Disease of Prematurity Using an Acoustic Method
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- Ultrasound Transducer Compatibility
研究概览
简要总结
The goal of this project is to develop a new noninvasive ultrasound based technique, called vibro-acoustic analysis (VAA), for evaluation of infant bone health with particular application in assessment of bone health in premature infants who are at risk for bone disease.
详细描述
With increased survival of very low birth weight and premature infants over recent decades, bone assessment has become especially vital with the recognition of metabolic bone disease (MBD) of prematurity. Bone assessment became especially vital during last decades with the growing emphasis on metabolic bone disease of prematurity and low-birth-weight infants. Statistics shows that up to 50% of low birth weight and preterm newborns are likely to develop metabolic bone disease. Currently, no screening test has been shown to provide both sensitive and specific evidence of developing MBD over the first several weeks of life in the premature infants. Therefore, there is a need for a non-invasive tool for evaluation of infant bone health. This study will be conducted on premature infants at risk for MBD at multiple time points during their growth, with full term infants as controls. vibro-acoustic analysis (VAA) measurements will be done on the tibia. VAA measurements for the premature infants will be compared to those of full term infants. Performance of VAA in identifying osteopenia and its ability to monitor the response to treatment will be evaluated. The investigators will use an ultrasound system that has been used in the pilot study and employ a transducer with a smaller footprint for pediatric application.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 3 Days 至 8 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Full term newborns, approximately equal number of male and female newborn, age <28 days.
- •Preterm infants, approximately equal number of male and female preterm infants with gestational age at birth <37 weeks or birth weight <1500 grams.
排除标准
- •Infants currently requiring continuous cardiovascular medication infusions, including but not limited to, dopamine, epinephrine, milrinone, and dobutamine (may have received these medications in the past.
- •Infants with major congenital anomalies that may affect bone health or structure.
- •For full term infants, infants with a history of intrauterine growth restriction or who are small for gestational age (<10th percentile for weight) at birth.
研究组 & 干预措施
premature infants and full term infants
The study visits will be at ≥3 time points at ages: within the first 28 days after birth, 2 months, 3 months, and, if still hospitalized, at 4 months and at 6 months.
- The ultrasound machine to the nursery or neonatal intensive care unit at a scheduled time.
- The appropriate ultrasound probe will be placed on the infant's tibia and a miniature hydrophone near the probe. A series of ultrasound measurements will be obtained and the ultrasound data will be saved for offline processing.
- The Investigators will repeat the measurement in 3 locations of the infant's tibia.
- Each ultrasound measurement takes a few seconds. The complete ultrasound study will take about 15 minutes at each visit.
- All procedures will be conducted in the nursery or neonatal intensive care unit to ensure infant safety.
- The ultrasound measurement for full-term infants can be done in ultrasound lab.
干预措施: Vibro-acoustic analysis (VAA), based on ultrasound radiation force (Diagnostic Test)
结局指标
主要结局
Ultrasound Transducer Compatibility
时间窗: 1 year
Successful acquisition and integration of a pediatric transducer with a footprint ≤ X cm² and focal depth ≤ Y mm (to be defined based on commercial availability and anatomical feasibility).
Hydrophone Sensitivity and Size
时间窗: 1 year
Selection and validation of a miniature hydrophone (e.g., diameter ≤ Z mm) with high sensitivity, characterized by its frequency response and minimum detectable pressure level.
Bandwidth Assessment
时间窗: 1 year
Measurement of hydrophone bandwidth (in MHz) as a primary indicator of sensitivity and signal capture quality.
System Performance Metrics
时间窗: 1 year
Quantitative assessment of signal-to-noise ratio (SNR) and resolution improvements compared to the previous setup using standard adult-sized components.
Feasibility in Preclinical Models
时间窗: 1 year
Demonstration of the optimized VAA system's ability to produce high-resolution, reproducible images in a neonatal bone phantom or relevant preclinical model.
次要结局
- Quantitative Bone Health Index (BHI)(through the study completion, up to 3 years)
- VAA Sensitivity to Gestational Age(through the study completion, up to 3 years)
- Longitudinal Changes in VAA Measurements(through the study completion, up to 3 years)
- Comparison with Clinical Markers (if available)(through the study completion, up to 3 years)