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Diagnostic Test

Ultrasound Technique for Osteopenia in Premature Infants

N/A

Waitlist Available

Led By Azra Alizad, MD

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Preterm infants, approximately equal number of male and female preterm infants with gestational age at birth <37 weeks or birth weight <1500 grams.

Be younger than 18 years old

Must not have

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.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through the study completion, up to 3 years

Awards & highlights

No Placebo-Only Group

Summary

This trial will test a new ultrasound technique to evaluate bone health in premature infants.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since VAA is a noninvasive diagnostic method based on ultrasound technology, it's expected to have minimal to no side effects. However, the trial will monitor for any unexpected reactions during the procedure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through the study completion, up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through the study completion, up to 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and through the study completion, up to 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Specific Aim 1 - Optimize VAA method for quantitative. The goal is to optimize the VAA system for small size of preterm tibia bone.

Secondary study objectives

Blood coagulation tests

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

0 / 2Eligibility criteria met