NCT00215098

Brief Summary

The purpose of this study is to determine at risk populations for certain congenital heart defects or certain operative procedures and to define the associated morbidity secondary to chylothorax - prolonged chest tube drainage, prolonged hospital stay, need for central access and hyperalimentation, subsequent infection.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2005

Geographic Reach
1 country

1 active site

Status
terminated

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

May 1, 2005

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 20, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2006

Completed
Last Updated

March 16, 2012

Status Verified

June 1, 2007

First QC Date

September 20, 2005

Last Update Submit

March 14, 2012

Conditions

Chylothorax

Keywords

pediatric healthcardiaccongenital heart surgerypost-operative chylous effusionsheart defectschildren

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients in the congenital surgery database

You may qualify if:

  • Patients in the congenital surgery database
  • patients have developed post-operative chylous effusions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Healthcare of Atlanta at Egleston

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Conditions

Chylothorax

Condition Hierarchy (Ancestors)

Pleural DiseasesRespiratory Tract Diseases

Study Officials

  • Brian Kogon, MD

    Emory University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 20, 2005

First Posted

September 22, 2005

Study Start

May 1, 2005

Study Completion

November 1, 2006

Last Updated

March 16, 2012

Record last verified: 2007-06

Locations

US(1)