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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 24, 2014