Ultrasound Technique for Osteopenia in Premature Infants

Palo Alto (17 mi)

Overseen byAzra Alizad, MD

Age: < 18

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: N/A

Waitlist Available

Sponsor: Mayo Clinic

No Placebo Group

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

This trial is for newborns under 28 days old, including both full-term and preterm infants. Preterm participants should be born before 37 weeks or weigh less than 1500 grams. Infants with growth issues at birth, major bone-related congenital anomalies, or those needing continuous heart medication infusions are excluded.

Inclusion Criteria

My baby was born prematurely, before 37 weeks or weighed less than 1500 grams.

Exclusion Criteria

My full-term baby was born smaller than 90% of babies at the same gestational age.

Treatment Details

The study is testing a new noninvasive ultrasound technique called vibro-acoustic analysis (VAA) to assess bone health in infants, especially premature ones who may have an increased risk of developing bone diseases like rickets or osteopenia.

1Treatment groups

Experimental Treatment

Group I: premature infants and full term infantsExperimental Treatment1 Intervention

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.