Ultrasound Technique for Osteopenia in Premature Infants

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Must not be taking: Cardiovascular infusions

Disqualifiers: Congenital anomalies, Growth restriction, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new ultrasound technique called vibro-acoustic analysis (VAA) to assess bone health in prematurely born babies. Premature infants face a higher risk of bone problems, and this method aims to evaluate their bone health without invasive procedures. The trial involves quick and safe ultrasound scans of the infants' tibia (a bone in the lower leg) multiple times during their first months. Families with preterm infants born before 37 weeks or weighing less than 1500 grams are well-suited for this study. As an unphased study, this trial allows families to contribute to innovative research that could enhance non-invasive bone health assessments for premature infants.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but infants currently on continuous cardiovascular medication infusions cannot participate.

What prior data suggests that this ultrasound technique is safe for infants?

Research has shown that vibro-acoustic analysis (VAA) is safe. In past studies, this method assessed infants' bone health without any reported problems. VAA is noninvasive, meaning it doesn't involve surgery or entering the body, which reduces risks. The ultrasound component of the procedure resembles those commonly used in medical imaging and is generally easy for patients to handle. In these studies, infants underwent the VAA process multiple times, and no safety issues emerged. Overall, the evidence suggests that VAA is a safe and well-tolerated method for monitoring bone health in premature infants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a new ultrasound technique to assess osteopenia in premature infants. Unlike traditional methods, which might involve more invasive procedures or exposure to radiation, this technique uses vibro-acoustic analysis (VAA) to provide a safer, non-invasive way to evaluate bone health. By using ultrasound waves and a hydrophone, this method could offer quick and accurate results, making it a promising tool for monitoring bone development in these vulnerable infants.

What evidence suggests that this ultrasound technique is effective for assessing bone health in premature infants?

Research has shown that vibro-acoustic analysis (VAA), the technique under study in this trial, could be a promising method for assessing bone health in premature babies. A small study found that VAA might help monitor the growth and strengthening of these babies' bones. This method uses ultrasound, which is safe and non-invasive. Although still in the early stages, these findings suggest that VAA could be a valuable tool for evaluating bone health in preterm babies at risk for bone problems. ^{1 2 3 4 6}

Who Is on the Research Team?

Azra Alizad, MD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

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.

My newborn is less than 28 days old.

Exclusion Criteria

My infant has a major birth defect affecting their bones.

My infant is on continuous heart medication infusions.

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial Assessment

Vibro-acoustic analysis (VAA) measurements are conducted on the tibia of premature and full-term infants at multiple time points.

6 months

Visits at birth, 2 months, 3 months, 4 months, and 6 months

Follow-up

Participants are monitored for changes in bone health using VAA and compared with clinical markers.

up to 3 years

What Are the Treatments Tested in This Trial?

Interventions

• Vibro-acoustic analysis (VAA)

Trial Overview 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.

How Is the Trial Designed?

Group I: premature infants and full term infants Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Collaborator

Trials

508

Recruited

1,090,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11324250/

Pulsed Vibro-Acoustic Analysis Technique for Monitoring ... The results of this pilot study indicate the potential use of vibro-acoustic analysis for monitoring the progression of bone mineralization in preterm infants.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04752098

A Study to Assess Metabolic Bone Disease of Prematurity ... The goal of this project is to develop a new noninvasive ultrasound based technique, called vibro-acoustic analysis (VAA), for evaluation of infant bone ...

3. researchgate.net researchgate.net/publication/382833690_Pulsed_Vibro-Acoustic_Analysis_Technique_for_Monitoring_Bone_Health_in_Preterm_Infants_A_Pilot_Study

(PDF) Pulsed Vibro-Acoustic Analysis Technique for ... The results of this pilot study indicate the potential use of vibro-acoustic analysis for monitoring the progression of bone mineralization in preterm infants.

4. withpower.com withpower.com/clinical-trials/for-osteopenia

Top Osteopenia Clinical Trials | Power 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 ...

5. mdpi.com mdpi.com/2227-9067/8/8/664

Physical Therapy to Prevent Osteopenia in Preterm Infants A daily exercise program of passive mobilizations with joint pressure, improves bone mineralization in preterm infants admitted to neonatal units.

6. mdpi.com mdpi.com/2072-6643/15/16/3515

Prenatal and Neonatal Bone Health: Updated Review on ... With this narrative review, we describe the current evidence for identifying patients with risk factors for developing osteopenia.