Clinical trial NCT04752098: 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
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Bone Disease
Osteopenia
Neonatal Rickets
Keywords: Bone Diseases
bone health
Fracture
infancy
Low Birth Weight Infant
mineralization
Neonatal
Pediatrics
Premature
ultrasound
Rickets
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
First posted: 2021-02-12
Enrollment: 37
Sex: ALL
Minimum age (years): 3
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Children (Newborns born full term (males and females), and infants born preterm (males and females)
Primary purpose: DIAGNOSTIC

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.

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.

Primary outcomes:
measure: Ultrasound Transducer Compatibility
timeFrame: 1 year
measure: Hydrophone Sensitivity and Size
timeFrame: 1 year
measure: Bandwidth Assessment
timeFrame: 1 year
measure: System Performance Metrics
timeFrame: 1 year
measure: Feasibility in Preclinical Models
timeFrame: 1 year
Secondary outcomes:
measure: Quantitative Bone Health Index (BHI)
timeFrame: through the study completion, up to 3 years
measure: VAA Sensitivity to Gestational Age
timeFrame: through the study completion, up to 3 years
measure: Longitudinal Changes in VAA Measurements
timeFrame: through the study completion, up to 3 years
measure: Comparison with Clinical Markers (if available)
timeFrame: through the study completion, up to 3 years
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Azra Alizad, MD
role: PRINCIPAL_INVESTIGATOR
References: