NCT00631397

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2007

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

February 27, 2008

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 7, 2008

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed
Last Updated

June 15, 2012

Status Verified

March 1, 2007

Enrollment Period

1.2 years

First QC Date

February 27, 2008

Last Update Submit

June 14, 2012

Conditions

Osteopenia Of Prematurity

Keywords

weakening of the bones

Outcome Measures

Primary Outcomes (1)

  • Develop ways to prevent and treat Osteopenia of Prematurity

    1-2 years

Study Arms (1)

Premature Infants

Premature Infants weighing less than 1500 gms

Device: Ultrasound machine

Interventions

Ultrasound machineDEVICE

Weekly Bone Density measurements using the Sonometer

Also known as: Omnisense 7000P Ultrasound Bone Sonometer
Premature Infants

Eligibility Criteria

Age24 Weeks - 33 Weeks
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Premature Infants In the Neonatal Intensive Care Unit

You may qualify if:

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

You may not qualify if:

  • congenital anomalies weight greater than 1500 gms

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tampa General Hospital/University of South Florida

Tampa, Florida, 33606, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Measuring proteins in the blood plasma

MeSH Terms

Conditions

Bone Diseases, Metabolic

Condition Hierarchy (Ancestors)

Bone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Terri L Ashmeade, M.D.

    University of South Florida

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 27, 2008

First Posted

March 7, 2008

Study Start

March 1, 2007

Primary Completion

May 1, 2008

Study Completion

May 1, 2008

Last Updated

June 15, 2012

Record last verified: 2007-03

Locations

US(1)