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Study of Hemodynamics of Neonates by Echocardiography and USCOM (HNEU)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2010 by Guangdong General Hospital.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Guangdong General Hospital
ClinicalTrials.gov Identifier:
NCT01045252
First received: January 8, 2010
Last updated: January 11, 2010
Last verified: January 2010
History of Changes
  Purpose

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.


Condition
Sepsis
Congenital Heart Disease

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Study of Hemodynamics of Healthy Neonates and Those With Congenital Heart Diseases and Sepsis by Echocardiography and USCOM

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Guangdong General Hospital:

Estimated Enrollment: 60
Study Start Date: October 2008
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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.

  Eligibility

Ages Eligible for Study:   up to 30 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

patients enrolled in the NICU of Guangdong General Hospital

Criteria

Inclusion Criteria:

  • neonatal
  • congenital heart disease
  • sepsis

Exclusion Criteria:

  • aged more than thirty days
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01045252

Locations
China, Guangdong
Guangdong General Hospital
Guangzhou, Guangdong, China, 510080
Sponsors and Collaborators
Guangdong General Hospital
Investigators
Principal Investigator: Shaoru He Guangdong General Hospital
  More Information

No publications provided

Responsible Party: Shaoru He, Guangdong General Hospital
ClinicalTrials.gov Identifier: NCT01045252     History of Changes
Other Study ID Numbers: CGGHHSR1132
Study First Received: January 8, 2010
Last Updated: January 11, 2010
Health Authority: China: Ethics Committee

Keywords provided by Guangdong General Hospital:
hemodynamics
neonatal

Additional relevant MeSH terms:
Heart Diseases
Sepsis
Toxemia
Heart Defects, Congenital
Cardiovascular Diseases
Infection
 Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Cardiovascular Abnormalities
Congenital Abnormalities

ClinicalTrials.gov processed this record on May 23, 2013