A Preliminary Study of Bone Density in Neonates

NCT ID: NCT00631397

Last Updated: 2012-06-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-03-31

Study Completion Date

2008-05-31

Brief Summary

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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.

Detailed Description

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

Conditions

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Osteopenia Of Prematurity

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Premature Infants

Premature Infants weighing less than 1500 gms

Ultrasound machine

Intervention Type DEVICE

Weekly Bone Density measurements using the Sonometer

Interventions

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Ultrasound machine

Weekly Bone Density measurements using the Sonometer

Intervention Type DEVICE

Other Intervention Names

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Omnisense 7000P Ultrasound Bone Sonometer

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* congenital anomalies weight greater than 1500 gms
Minimum Eligible Age

24 Weeks

Maximum Eligible Age

33 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of South Florida

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Terri L Ashmeade, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of South Florida

Locations

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Tampa General Hospital/University of South Florida

Tampa, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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University of South Florida

Identifier Type: -

Identifier Source: secondary_id

Grant

Identifier Type: -

Identifier Source: secondary_id

5974

Identifier Type: -

Identifier Source: org_study_id

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