Status:
COMPLETED
A Study to Assess Metabolic Bone Disease of Prematurity Using an Acoustic Method
Lead Sponsor:
Mayo Clinic
Collaborating Sponsors:
National Institutes of Health (NIH)
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Conditions:
Metabolic Bone Disease
Osteopenia
Eligibility:
All Genders
3-8 years
Phase:
NA
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 assessmen...
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 prematur...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 2 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 31 2024
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT04752098
Start Date
September 2 2020
End Date
August 31 2024
Last Update
April 27 2025
Active Locations (1)
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1
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905