A Study to Assess Metabolic Bone Disease of Prematurity Using an Acoustic Method
- Conditions
- OsteopeniaNeonatal RicketsMetabolic Bone Disease
- Interventions
- Diagnostic Test: Vibro-acoustic analysis (VAA), based on ultrasound radiation force
- Registration Number
- NCT04752098
- Lead Sponsor
- Mayo Clinic
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 37
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description premature infants and full term infants Vibro-acoustic analysis (VAA), based on ultrasound radiation force 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.
- Primary Outcome Measures
Name Time Method Ultrasound Transducer Compatibility 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 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 1 year Measurement of hydrophone bandwidth (in MHz) as a primary indicator of sensitivity and signal capture quality.
System Performance Metrics 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 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 Outcome Measures
Name Time Method Quantitative Bone Health Index (BHI) through the study completion, up to 3 years Derived from vibro-acoustic assessment (VAA) of the tibia in both term and preterm infants, BHI will be compared across age-adjusted groups to determine baseline differences between preterm and term infants.
VAA Sensitivity to Gestational Age through the study completion, up to 3 years Correlation of VAA-derived parameters with gestational age at birth to assess the method's sensitivity in detecting bone development differences attributable to prematurity.
Longitudinal Changes in VAA Measurements through the study completion, up to 3 years Assessment of VAA parameter changes over serial visits in preterm infants undergoing standard nutritional or medical interventions. Evaluates VAA's ability to detect improvements or deteriorations in bone status over time.
Comparison with Clinical Markers (if available) through the study completion, up to 3 years Cross-validation of VAA findings with available clinical or biochemical markers of bone health (e.g., serum calcium, phosphate, ALP levels) to evaluate concurrent validity.
Trial Locations
- Locations (1)
Mayo Clinic in Rochester
🇺🇸Rochester, Minnesota, United States