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Completed

NCT Number: NCT04752098

A Study to Assess 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.

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Key information

Conditions

Metabolic Bone Disease Avitaminosis Bone Diseases Bone Diseases, Metabolic Calcinosis Calcium Metabolism Disorders Deficiency Diseases Female Urogenital Diseases and Pregnancy Complications Fractures, Bone Malnutrition Metabolic Diseases Musculoskeletal Diseases Neonatal Rickets Nutrition Disorders Nutritional and Metabolic Diseases Obstetric Labor Complications Obstetric Labor, Premature Osteopenia Pregnancy Complications Premature Birth Rickets Urogenital Diseases Vitamin D Deficiency Wounds and Injuries

Age range

3 day–8 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Vibro-acoustic analysis (VAA), based on ultrasound radiation force

Diagnostic Test

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.

Other names: ultrasound

Primary outcomes

  1. 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).

  2. 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.

  3. Bandwidth Assessment

    Time frame: 1 year

    Measurement of hydrophone bandwidth (in MHz) as a primary indicator of sensitivity and signal capture quality.

  4. 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.

  5. 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

  1. Quantitative Bone Health Index (BHI)

    Time frame: 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.

  2. VAA Sensitivity to Gestational Age

    Time frame: 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.

  3. Longitudinal Changes in VAA Measurements

    Time frame: 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.

  4. Comparison with Clinical Markers (if available)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
  • National Institutes of Health (NIH)

Registry information

Official study title

Assessment of Metabolic Bone Disease of Prematurity Using an Acoustic Method

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Feb 12, 2021
Registry last updated
Apr 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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