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A Preliminary Study of Bone Density in Neonates

This study has been completed.
Information provided by (Responsible Party):
University of South Florida Identifier:
First received: February 27, 2008
Last updated: June 14, 2012
Last verified: March 2007
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.

Condition Intervention
Osteopenia Of Prematurity
Device: Ultrasound machine

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Preliminary Study of Bone Density Measurements in Neonates Using the Sunlight Omnisense 7000P Ultrasound Bone Sonometer

Resource links provided by NLM:

Further study details as provided by University of South Florida:

Primary Outcome Measures:
  • Develop ways to prevent and treat Osteopenia of Prematurity [ Time Frame: 1-2 years ]

Biospecimen Retention:   Samples Without DNA
Measuring proteins in the blood plasma

Enrollment: 40
Study Start Date: March 2007
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Premature Infants
Premature Infants weighing less than 1500 gms
Device: Ultrasound machine
Weekly Bone Density measurements using the Sonometer
Other Name: Omnisense 7000P Ultrasound Bone Sonometer

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

Ages Eligible for Study:   24 Weeks to 33 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Premature Infants In the Neonatal Intensive Care Unit

Inclusion Criteria:

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

Exclusion Criteria:

  • congenital anomalies weight greater than 1500 gms
  Contacts and Locations
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Please refer to this study by its identifier: NCT00631397

United States, Florida
Tampa General Hospital/University of South Florida
Tampa, Florida, United States, 33606
Sponsors and Collaborators
University of South Florida
Principal Investigator: Terri L Ashmeade, M.D. University of South Florida
  More Information

Responsible Party: University of South Florida Identifier: NCT00631397     History of Changes
Other Study ID Numbers: 5974
University of South Florida
Study First Received: February 27, 2008
Last Updated: June 14, 2012

Keywords provided by University of South Florida:
weakening of the bones

Additional relevant MeSH terms:
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases processed this record on May 23, 2017