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Diagnostic Test

Ultrasound Technique for Osteopenia in Premature Infants

Q: Is there an age limit for enrolling in this experiment?

This clinical trial requires patients to be between 3 days and 8 months old. Additionally, there are 11 trials for infants and 43 trials that involve seniors over 65 years of age.

Q: Can I join the experiment to explore potential benefits?

This research is searching for 50 infants between 3 days and 8 months of age with osteopenia. To qualify, the participants must be full-term newborns or preterm infants that are gender balanced in their respective categories (birth weight &#x3C;1500 grams, gestational age &#x3C;37 weeks).

Q: Is the recruitment phase of this clinical trial still accepting participants?

According to the details on clinicaltrials.gov, this particular trial is not currently recruiting patients for participation; it was initially posted in September of 2020 and last edited in early February 2022. Although no longer enrolling individuals, there are 55 alternative trials presently searching for participants.

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through the study completion, up to 3 years

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

Blood coagulation tests

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 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor

3,205 Previous Clinical Trials

3,766,734 Total Patients Enrolled

National Institutes of Health (NIH)NIH

2,696 Previous Clinical Trials

6,952,538 Total Patients Enrolled

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

483 Previous Clinical Trials

1,086,890 Total Patients Enrolled

Media Library

Vibro-acoustic analysis (VAA) (Diagnostic Test) Clinical Trial Eligibility Overview. Trial Name: NCT04752098 — N/A

Metabolic Bone Diseases Research Study Groups: premature infants and full term infants

Metabolic Bone Diseases Clinical Trial 2023: Vibro-acoustic analysis (VAA) Highlights & Side Effects. Trial Name: NCT04752098 — N/A

Vibro-acoustic analysis (VAA) (Diagnostic Test) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04752098 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there an age limit for enrolling in this experiment?

"This clinical trial requires patients to be between 3 days and 8 months old. Additionally, there are 11 trials for infants and 43 trials that involve seniors over 65 years of age."

Answered by AI

Can I join the experiment to explore potential benefits?

"This research is searching for 50 infants between 3 days and 8 months of age with osteopenia. To qualify, the participants must be full-term newborns or preterm infants that are gender balanced in their respective categories (birth weight <1500 grams, gestational age <37 weeks)."

Answered by AI

Is the recruitment phase of this clinical trial still accepting participants?

"According to the details on clinicaltrials.gov, this particular trial is not currently recruiting patients for participation; it was initially posted in September of 2020 and last edited in early February 2022. Although no longer enrolling individuals, there are 55 alternative trials presently searching for participants."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study to Assess Metabolic Bone Disease of Prematurity Using an Acoustic Method

Azra Alizad 2020. "A Study to Assess Metabolic Bone Disease of Prematurity Using an Acoustic Method". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04752098.

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