A Study to Assess Metabolic Bone Disease of Prematurity Using an Acoustic Method

NCT04752098 | Completed

• 3 other identifiers: 19-0014981R21AR075370-01A15R21AR075370-02
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

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.

Conditions

Metabolic Bone Disease; Osteopenia; Neonatal Rickets

Keywords

Bone Diseases; bone health; Fracture; infancy; Low Birth Weight Infant; mineralization; Neonatal; Pediatrics; Premature; ultrasound; Rickets

Outcome Measures

Primary Outcomes (5)

• 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).

  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.

  1 year

• Bandwidth Assessment

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

  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.

  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.

  1 year

Secondary Outcomes (4)

• 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

Study Arms (1)

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.

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

Interventions

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.

Also known as: ultrasound

premature infants and full term infants

Eligibility Criteria

• Age: 3 Days - 8 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead
• National Institutes of Health (NIH): collaborator
• National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS): collaborator

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Bone Diseases, Metabolic; Bone Diseases; Fractures, Bone; Calcinosis; Premature Birth; Rickets

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Wounds and Injuries; Calcium Metabolism Disorders; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Vitamin D Deficiency; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Azra Alizad, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Children (Newborns born full term (males and females), and infants born preterm (males and females)

Study Record Dates

• First Submitted: February 2, 2021
• First Posted: February 12, 2021
• Study Start: September 2, 2020
• Primary Completion: August 31, 2024
• Study Completion: August 31, 2024
• Last Updated: April 27, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)