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A Preliminary Study of Bone Density in Neonates

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of South Florida
ClinicalTrials.gov Identifier:
NCT00631397
First received: February 27, 2008
Last updated: June 14, 2012
Last verified: March 2007
History of Changes
  Purpose

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:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   24 Weeks to 33 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Premature Infants In the Neonatal Intensive Care Unit

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00631397

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

No publications provided

Responsible Party: University of South Florida
ClinicalTrials.gov Identifier: NCT00631397     History of Changes
Other Study ID Numbers: 5974, University of South Florida, Grant
Study First Received: February 27, 2008
Last Updated: June 14, 2012
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on June 18, 2013