An interventional study of Vibro-acoustic analysis (VAA), based on ultrasound radiation force in Metabolic Bone Disease, Osteopenia and Neonatal Rickets, sponsored by Mayo Clinic. Completed at 1 site in United States. Open to participants aged 3 Days to 8 Months. Per ClinicalTrials.gov, last updated 2025-04-27.
Sponsored by Mayo Clinic · Not applicable, Interventional, and Diagnostic
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.
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.
36 studies on the registry are indexed under Rickets; 2 are open to participants now.
This study's enrollment of 37 is above the median of 23 across 22 interventional studies indexed under Rickets.
Browse Rickets studies →Mayo Clinic is the lead sponsor of 3,269 studies on the registry; 672 are open to participants now.
Of its 452 completed or terminated interventional studies of FDA-regulated products, 321 (71%) have results posted.
Compared within Rickets, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Bone Diseases, Metabolic. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
Diagnostic Test: Vibro-acoustic analysis (VAA), based on ultrasound radiation force
The study will develop and validate a new ultrasonic method for assessment of infant bone by evaluating structural and mechanical characteristics of the infant tibia. This project will utilize a novel, non-invasive method, vibro-acoustic analysis (VAA), to evaluate infant bone properties in a wide frequency range while reducing the artifacts from soft tissue.
Also known as: ultrasound
Ultrasound Transducer Compatibility
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).
Time frame: 1 year
Hydrophone Sensitivity and Size
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.
Time frame: 1 year
Bandwidth Assessment
Measurement of hydrophone bandwidth (in MHz) as a primary indicator of sensitivity and signal capture quality.
Time frame: 1 year
System Performance Metrics
Quantitative assessment of signal-to-noise ratio (SNR) and resolution improvements compared to the previous setup using standard adult-sized components.
Time frame: 1 year
Feasibility in Preclinical Models
Demonstration of the optimized VAA system's ability to produce high-resolution, reproducible images in a neonatal bone phantom or relevant preclinical model.
Time frame: 1 year
Quantitative Bone Health Index (BHI)
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.
Time frame: through the study completion, up to 3 years
VAA Sensitivity to Gestational Age
Correlation of VAA-derived parameters with gestational age at birth to assess the method's sensitivity in detecting bone development differences attributable to prematurity.
Time frame: through the study completion, up to 3 years
Longitudinal Changes in VAA Measurements
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.
Time frame: through the study completion, up to 3 years
Comparison with Clinical Markers (if available)
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.
Time frame: through the study completion, up to 3 years
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
This study is completed, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.