search
Back to results

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

Primary Purpose

Metabolic Bone Disease, Osteopenia, Neonatal Rickets

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Vibro-acoustic analysis (VAA), based on ultrasound radiation force
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Metabolic Bone Disease focused on measuring Bone Diseases, bone health, Fracture, infancy, Low Birth Weight Infant, mineralization, Neonatal, Pediatrics, Premature, ultrasound, Rickets

Eligibility Criteria

3 Days - 8 Months (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Mayo Clinic in Rochester

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

premature infants and full term infants

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
February 2, 2021
Last Updated
February 21, 2023
Sponsor
Mayo Clinic
Collaborators
National Institutes of Health (NIH), National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
search

1. Study Identification

Unique Protocol Identification Number
NCT04752098
Brief Title
A Study to Assess Metabolic Bone Disease of Prematurity Using an Acoustic Method
Official Title
Assessment of Metabolic Bone Disease of Prematurity Using an Acoustic Method
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
September 2, 2020 (Actual)
Primary Completion Date
January 2026 (Anticipated)
Study Completion Date
September 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
Collaborators
National Institutes of Health (NIH), National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Bone Disease, Osteopenia, Neonatal Rickets
Keywords
Bone Diseases, bone health, Fracture, infancy, Low Birth Weight Infant, mineralization, Neonatal, Pediatrics, Premature, ultrasound, Rickets

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Children (Newborns born full term (males and females), and infants born preterm (males and females)
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
premature infants and full term infants
Arm Type
Other
Arm Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Vibro-acoustic analysis (VAA), based on ultrasound radiation force
Other Intervention Name(s)
ultrasound
Intervention Description
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.
Primary Outcome Measure Information:
Title
Specific Aim 1 - Optimize VAA method for quantitative. The goal is to optimize the VAA system for small size of preterm tibia bone.
Description
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.
Time Frame
1 year.
Secondary Outcome Measure Information:
Title
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.
Description
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.
Time Frame
through the study completion, up to 3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Days
Maximum Age & Unit of Time
8 Months
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Azra Alizad, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials

Learn more about this trial

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

We'll reach out to this number within 24 hrs