NCT00366821

Brief Summary

Our hope is that the information from this retrospective study will provide information to better serve our patients and their parents with risk stratification (levels of risk) and clinical expectations of patients after cardiac surgery who have genetic abnormalities and those who do not have genetic abnormalities.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2002

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

January 1, 2002

Completed
4.6 years until next milestone

First Submitted

Initial submission to the registry

August 17, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 21, 2006

Completed
8.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
Last Updated

December 2, 2014

Status Verified

November 1, 2014

Enrollment Period

12.8 years

First QC Date

August 17, 2006

Last Update Submit

November 26, 2014

Conditions

Congenital Disorders

Keywords

cardiacpediatricgenetic

Outcome Measures

Primary Outcomes (1)

  • We wish to examine the outcomes following cardiac surgery in newborns with genetic abnormalities compared to those newborns without genetic abnormalities.

    We wish to examine the outcomes following cardiac surgery in newborns with genetic abnormalities compared to those newborns without genetic abnormalities.

    5 years

Study Arms (2)

1

Examine the outcomes following cardiac surgery in those newborns with genetic abnormalities.

2

Examine the outcomes following cardiac surgery in newborns without genetic abnormalities.

Eligibility Criteria

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

Patients' charts will be reviewed from Children's Healtcare of Atlanta between January 1, 2002 through December 31, 2006 of all neonates who underwent cardiac surgery.

You may qualify if:

  • neonates (newborns\< 30 days of age)
  • cardiac surgery between 1/1/02 - 5/31/06
  • at Children's Healthcare of Atlanta

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Healthcare of Atlanta

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Conditions

Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Janet M Simsic, MD

    Children's Healthcare of Atlanta

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 17, 2006

First Posted

August 21, 2006

Study Start

January 1, 2002

Primary Completion

November 1, 2014

Study Completion

November 1, 2014

Last Updated

December 2, 2014

Record last verified: 2014-11

Locations

US(1)