A Preliminary Study of Bone Density in Neonates

Osteopenia Of Prematurity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00631397
• Other study ID #: 5974
• Secondary ID: University of So
• Status: Completed
• Phase: N/A
• First received: February 27, 2008
• Last updated: June 14, 2012
• Start date: March 2007
• Est. completion date: May 2008

Study information

• Verified date: March 2007
• Source: University of South Florida
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: May 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 24 Weeks to 33 Weeks

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• congenital anomalies weight greater than 1500 gms

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Osteopenia Of Prematurity

Intervention

Device:
• Ultrasound machine
Weekly Bone Density measurements using the Sonometer

Locations

Country	Name	City	State
United States	Tampa General Hospital/University of South Florida	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of South Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Develop ways to prevent and treat Osteopenia of Prematurity		1-2 years	No