Metabolic Bone DiseaseNCT04752098
A Study to Assess Metabolic Bone Disease of Prematurity Using an Acoustic Method
A study testing Vibro-acoustic analysis (VAA), based on ultrasound radiation force in people with Metabolic Bone Disease and Osteopenia, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 days to 8 months
- Conditions the study is for
- Metabolic Bone Disease, Osteopenia, Neonatal Rickets
- What is being tested?
- Vibro-acoustic analysis (VAA), based on ultrasound radiation force
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Sep 2020to 31 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 days to 8 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: Assessment of Metabolic Bone Disease of Prematurity Using an Acoustic Method
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.
Read the 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.
- Conditions
- Metabolic Bone Disease, Osteopenia, Neonatal Rickets
- Being tested
- Vibro-acoustic analysis (VAA), based on ultrasound radiation force
- Keywords
- Bone Diseases, bone health, Fracture, infancy, Low Birth Weight Infant, mineralization, Neonatal, Pediatrics, Premature, ultrasound, Rickets
- Medical subject headings
- Bone Diseases, Metabolic, Bone Diseases, Fractures, Bone, Calcinosis, Premature Birth, Rickets
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vibro-acoustic analysis (VAA), based on ultrasound radiation forceDiagnostic test
Also called ultrasound
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.
| Study group | Role | What they receive |
|---|---|---|
| premature infants and full term infants | Other | 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. Receives: Diagnostic Test: Vibro-acoustic analysis (VAA), based on ultrasound radiation force |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 1 year
Bandwidth Assessment
Measurement of hydrophone bandwidth (in MHz) as a primary indicator of sensitivity and signal capture quality.
Measured: 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.
Measured: 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.
Measured: 1 year
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: through the study completion, up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2021
- Study start2 Sep 2020
- Primary completion31 Aug 2024
- Study completion31 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic Bone DiseaseStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Children (Newborns born full term (males and females), and infants born preterm (males and females)
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Responsible party
- Principal investigator, Azra Alizad, Mayo Clinic
- Investigators
- Azra Alizad, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04752098
- Sponsor's protocol ID
- 19-001498
- Other IDs
- 1R21AR075370-01A1, 5R21AR075370-02
- Status last verified
- Apr 2025
- First submitted
- 2 Feb 2021
- Last updated
- 27 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Metabolic Bone Disease of Prematurity Using an Acoustic Method
- ClinicalTrials.gov ID
- NCT04752098
- Acronym / sponsor ID
- 19-001498
- Conditions
- Metabolic Bone Disease, Osteopenia, Neonatal Rickets
- Keywords
- Bone Diseases, bone health, Fracture, infancy, Low Birth Weight Infant, mineralization, Neonatal, Pediatrics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Study start
- 2 Sep 2020 (actual)
- Primary completion
- 31 Aug 2024 (actual)
- Study completion
- 31 Aug 2024 (actual)
- First posted
- 12 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Children (Newborns born full term (males and females), and infants born preterm (males and females)
| Arm | Type | Receives |
|---|---|---|
| premature infants and full term infants | Other | Diagnostic Test: Vibro-acoustic analysis (VAA), based on ultrasound radiation forceThe 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. |
Who may qualify
- Ages
- 3 days to 8 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vibro-acoustic analysis (VAA), based on ultrasound radiation forceAlso: ultrasoundThe 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. | Diagnostic test | premature infants and full term infants |
Primary outcome
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.
4 secondary outcomes
Quantitative Bone Health Index (BHI)
Time frame: through the study completion, up to 3 years
VAA Sensitivity to Gestational Age
Time frame: through the study completion, up to 3 years
Longitudinal Changes in VAA Measurements
Time frame: through the study completion, up to 3 years
Comparison with Clinical Markers (if available)
Time frame: through the study completion, up to 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Azra Alizad, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vibro-acoustic analysis (VAA), based on ultrasound radiation force in people with Metabolic Bone Disease and Osteopenia, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ultrasound Transducer Compatibility (time frame: 1 year). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2025.