NCT01045252

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2008

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2008

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

January 8, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 11, 2010

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

January 12, 2010

Status Verified

January 1, 2010

Enrollment Period

2.2 years

First QC Date

January 8, 2010

Last Update Submit

January 11, 2010

Conditions

SepsisCongenital Heart Disease

Keywords

hemodynamicsneonatal

Study Arms (3)

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.

Eligibility Criteria

AgeUp to 30 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

patients enrolled in the NICU of Guangdong General Hospital

You may qualify if:

  • neonatal
  • congenital heart disease
  • sepsis

You may not qualify if:

  • aged more than thirty days

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Guangdong General Hospital

Guangzhou, Guangdong, 510080, China

Location

MeSH Terms

Conditions

SepsisHeart Defects, Congenital

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsCardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Shaoru He

    Guangdong Provincial People's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 8, 2010

First Posted

January 11, 2010

Study Start

October 1, 2008

Primary Completion

December 1, 2010

Study Completion

December 1, 2011

Last Updated

January 12, 2010

Record last verified: 2010-01

Locations

CN(1)