NCT04752098

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

Assessment of Metabolic Bone Disease of Prematurity Using an Acoustic Method

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 3 Days – 8 Months
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2020-09-02
• Primary completion: 2024-08-31
• Completion: 2024-08-31
• First posted: 2021-02-12
• Last updated: 2025-04-27

Locations

1 site across 1 country: United States