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HNEU: Study of Hemodynamics of Neonates by Echocardiography and USCOM

Sponsor
Guangdong Provincial People's Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT01045252
Collaborator
(none)
60
Enrollment
1
Location
38
Duration (Months)
1.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    60 participants
    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
    Study Start Date :
    Oct 1, 2008
    Anticipated Primary Completion Date :
    Dec 1, 2010
    Anticipated Study Completion Date :
    Dec 1, 2011

    Arms and Interventions

    Arm Intervention/Treatment
    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.

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      N/A to 30 Days
      Sexes Eligible for Study:
      All
      Accepts Healthy Volunteers:
      No
      Inclusion Criteria:

      • neonatal

      • congenital heart disease

      • sepsis

      Exclusion Criteria:
      • aged more than thirty days

      Contacts and Locations

      Locations

      Site City State Country Postal Code
      1 Guangdong General Hospital Guangzhou Guangdong China 510080

      Sponsors and Collaborators

      • Guangdong Provincial People's Hospital

      Investigators

      • Principal Investigator: Shaoru He, Guangdong Provincial People's Hospital

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      None provided.
      Responsible Party:
      , ,
      ClinicalTrials.gov Identifier:
      NCT01045252
      Other Study ID Numbers:
      • CGGHHSR1132
      First Posted:
      Jan 11, 2010
      Last Update Posted:
      Jan 12, 2010
      Last Verified:
      Jan 1, 2010
      Keywords provided by , ,
      hemodynamics
      neonatal
      Additional relevant MeSH terms:
      Sepsis
      Heart Diseases
      Heart Defects, Congenital

      Study Results

      No Results Posted as of Jan 12, 2010