Assessment of Metabolic Bone Disease of Prematurity Using an Acoustic Method
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Mayo Clinic
- Enrollment
- 37
- Locations
- 2
- Primary Endpoint
- Ultrasound Transducer Compatibility
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 3 Days to 8 Months (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Ultrasound Transducer Compatibility
Time Frame: 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
Time Frame: 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
Time Frame: 1 year
Measurement of hydrophone bandwidth (in MHz) as a primary indicator of sensitivity and signal capture quality.
System Performance Metrics
Time Frame: 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
Time Frame: 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.
Secondary Outcomes
- 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)
Investigators
Azra Alizad
Principal Investigator
Mayo Clinic