A Preliminary Study of Bone Density in Neonates

June 14, 2012 updated by: University of South Florida

A Preliminary Study of Bone Density Measurements in Neonates Using the Sunlight Omnisense 7000P Ultrasound Bone Sonometer

The study is to measure how dense or solid the infant's bones are using a new ultrasound machine and how that density changes over time.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

premature infants weighing less than 1500 gms and less than 33 weeks gestation are eligible for the study

Study Type

Observational

Enrollment (Actual)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Tampa, Florida, United States, 33606
        • Tampa General Hospital/University of South Florida

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 months to 7 months (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Premature Infants In the Neonatal Intensive Care Unit

Description

Inclusion Criteria:

  • premature infants born less than 33 weeks, weighing less than 1500 gms

Exclusion Criteria:

  • congenital anomalies weight greater than 1500 gms

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Premature Infants
Premature Infants weighing less than 1500 gms
Device: Ultrasound machine
Weekly Bone Density measurements using the Sonometer
Other Names:
  • Omnisense 7000P Ultrasound Bone Sonometer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Develop ways to prevent and treat Osteopenia of Prematurity
Time Frame: 1-2 years
1-2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of South Florida

Investigators

  • Principal Investigator: Terri L Ashmeade, M.D., University of South Florida

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2007

Primary Completion (ACTUAL)

May 1, 2008

Study Completion (ACTUAL)

May 1, 2008

Study Registration Dates

First Submitted

February 27, 2008

First Submitted That Met QC Criteria

February 27, 2008

First Posted (ESTIMATE)

March 7, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

June 15, 2012

Last Update Submitted That Met QC Criteria

June 14, 2012

Last Verified

March 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5974
  • Grant (Other Grant/Funding Number: Juan Rodés Grant (JR23/00018))
  • University of South Florida

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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