Study of Hemodynamics of Neonates by Echocardiography and... | NCT01045252

Studies
Study of Hemodynamics of Neonates by Echocardiography and USCOM

NCT01045252

Sponsor

Guangdong Provincial People's Hospital

Status

Unknown status

Last Update Posted

Jan 12, 2010Estimated

Enrollment

60Estimated

Phase

Not provided

Conditions

Sepsis
Congenital Heart Disease

Interventions

Not provided

Countries

China

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

Jan 2010

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2008

Primary Completion Date

Dec 2010Estimated

Completion Date

Dec 2011Estimated

First Submitted Date

Jan 8, 2010

First Submission Date that Met QC Criteria

Jan 8, 2010

First Posted Date

Jan 11, 2010Estimated

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

Jan 11, 2010

Last Update Posted Date

Jan 12, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

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 purpose of this study is to evaluate the hemodynamic values of neonates that are healthy and those with various congenital heart diseases and sepsis by using echocardiography and USCOM.

Detailed Description

Echocardiography is a diagnostic tool for congenital heart disease.However,it requires skilled specialists to perform it and is a little expensive.Besides,it is too big to move to the bedside easily.USCOM is another newly choice to evaluate hemodynamic values in recent years.This study will compare the hemodynamic values of neonates that are healthy and those with congenital heart diseases and sepsis by using echocardiography and USCOM.

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

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
congenital heart disease		Neonates that are enrolled in the NICU and are confirmed of congenital heart diseases.
sepsis		Neonates that are enrolled in the NICU and are diagnosed as sepsis.
Health		Neonates that are enrolled in the NICU and have no congenital heart diseases and sepsis.

Interventions

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

neonatal
congenital heart disease
sepsis

Exclusion Criteria:

aged more than thirty days

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

30 Days

Standard Ages

Child

Study Population

patients enrolled in the NICU of Guangdong General Hospital

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Shaoru He	Guangdong Provincial People's Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Guangdong General Hospital		Guangzhou	Guangdong	510080	China

Condition Browse Module

MeSH Terms

ID	Term
D018805	Sepsis
D006330	Heart Defects, Congenital

Ancestor Terms

ID	Term
D007239	Infections
D018746	Systemic Inflammatory Response Syndrome
D007249	Inflammation
D010335	Pathologic Processes

Browse Leaves

Not provided

Browse Branches

Not provided