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

Osteopenia Clinical Trial

Official title:

Assessment of Metabolic Bone Disease of Prematurity Using an Acoustic Method

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04752098
• Other study ID #: 19-001498
• Secondary ID: 1R21AR075370-01A
• Status: Enrolling by invitation
• Phase: N/A
• Start date: September 2, 2020
• Est. completion date: September 2026

Study information

• Verified date: March 2024
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 50
• Est. completion date: September 2026
• Est. primary completion date: January 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Days to 8 Months

Eligibility

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.

Related Conditions & MeSH terms

• Bone Diseases
• Bone Diseases, Metabolic
• Metabolic Bone Disease
• Neonatal Rickets
• Osteopenia
• Rickets

Intervention

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.

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (3)

Lead Sponsor	Collaborator
Mayo Clinic	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Specific Aim 1 - Optimize VAA method for quantitative. The goal is to optimize the VAA system for small size of preterm tibia bone.	Obtaining a pediatric ultrasound transducer with smaller footprint and shallower focus is the first step for optimization. Secondly, using smallest size hydrophone with a high receiver sensitivity complete the optimization. The investigators will consider hydrophone bandwidth as a measure for optimal sensitivity.	1 year.
Secondary	Specific Aim 2: Determine the efficacy of the VAA method for quantitative assessment of tibia bone in a pilot study of term and preterm infants. The goal is to measure the bone health of preterm newborn using our new ultrasound method.	Vibro-acoustic measurements for the age-adjusted premature infants will be compared to those of normal infants. Performance of vibro-acoustic in monitoring the treatment will be assessed by comparing to the measurement of previous visits.	through the study completion, up to 3 years