A Preliminary Study of Bone Density in Neonates | NCT00631397

Studies
A Preliminary Study of Bone Density in Neonates

NCT00631397

Sponsor

University of South Florida

Status

Completed

Last Update Posted

Jun 15, 2012Estimated

Enrollment

40Actual

Phase

Not provided

Conditions

Osteopenia Of Prematurity

Interventions

Ultrasound machine

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2007

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2007

Primary Completion Date

May 2008Actual

Completion Date

May 2008Actual

First Submitted Date

Feb 27, 2008

First Submission Date that Met QC Criteria

Feb 27, 2008

First Posted Date

Mar 7, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 14, 2012

Last Update Posted Date

Jun 15, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Premature Infants		Premature Infants weighing less than 1500 gms	Device: Ultrasound machine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ultrasound machine	Device	Weekly Bone Density measurements using the Sonometer	Premature Infants

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Develop ways to prevent and treat Osteopenia of Prematurity		1-2 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

congenital anomalies weight greater than 1500 gms

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

24 Weeks

Maximum Age

33 Weeks

Standard Ages

Child

Study Population

Premature Infants In the Neonatal Intensive Care Unit

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Terri L Ashmeade, M.D.	University of South Florida	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Tampa General Hospital/University of South Florida		Tampa	Florida	33606	United States

Condition Browse Module

MeSH Terms

ID	Term
D001851	Bone Diseases, Metabolic

Ancestor Terms

ID	Term
D001847	Bone Diseases
D009140	Musculoskeletal Diseases
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided