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

Sponsor

Mayo Clinic (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT04752098

Collaborator

National Institutes of Health (NIH) (NIH), National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) (NIH)

Enrollment

Location

Arm

72.9

Anticipated Duration (Months)

0.7

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Metabolic Bone Disease Osteopenia Neonatal Rickets	Diagnostic Test: Vibro-acoustic analysis (VAA), based on ultrasound radiation force	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

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

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

Assessment of Metabolic Bone Disease of Prematurity Using an Acoustic Method

Actual Study Start Date :

Sep 2, 2020

Anticipated Primary Completion Date :

Jan 30, 2026

Anticipated Study Completion Date :

Sep 30, 2026

Arms and Interventions

Arm	Intervention/Treatment
Other: 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.	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. Other Names: ultrasound

Arm

Intervention/Treatment

Other: 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.

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.

Other Names:

ultrasound

Outcome Measures

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. [1 year.]
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. [through the study completion, up to 3 years]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

3 Days to 8 Months

Sexes Eligible for Study:

All

Accepts 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.