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

NCT ID: NCT04752098

Last Updated: 2025-04-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 37 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-02
• Study Completion Date: 2024-08-31

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.

Conditions

Metabolic Bone Disease; Osteopenia; Neonatal Rickets

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

premature infants and full term infants

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.

Group Type: OTHER

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

Intervention Type: 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.

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

ultrasound

Eligibility Criteria

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.

• Minimum Eligible Age: 3 Days
• Maximum Eligible Age: 8 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

NIH

Sponsor Role: collaborator

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Azra Alizad

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Azra Alizad, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Countries

United States

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

1R21AR075370-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

5R21AR075370-02

Identifier Type: NIH

Identifier Source: secondary_id

View Link

19-001498

Identifier Type: -

Identifier Source: org_study_id