NCT00366561

Brief Summary

The purpose of this retrospective study is to identify all neonates (newborns \< 30 days of age) from January 1, 2002 through June 20, 2006 at Children's Healthcare of Atlanta who have suffered neurological complications following cardiac surgery. This retrospective study is important to identify the incidence, care and follow-up of neurological complications at this institution

Trial Health

87
On Track

Trial Health Score

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

Enrollment
810

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
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
Last Updated

December 2, 2014

Status Verified

November 1, 2014

Enrollment Period

8.3 years

First QC Date

August 17, 2006

Last Update Submit

November 26, 2014

Conditions

Congenital Disorders

Keywords

neonatesneurological complicationssurgery

Outcome Measures

Primary Outcomes (1)

  • The purpose of this study was to examine short term outcomes following cardiac surgery in premature neonates.

    In congenital cardiac defects where there was a choice of palliation vs complete anatomic repair, premature neonates underwent palliative procedures more frequently than term neonates. Premature neonates spent more days of mechanical ventilation compared to their term counterparts. Importantly, there was no difference in mortality between the two groups.

    6 years

Eligibility Criteria

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

All neonates (newborns \< 30 days of age) from January 1, 2002 through June 20, 2006 at Children's Healthcare of Atlanta who have suffered neurological complications following cardiac surgery.

You may qualify if:

  • Children's Healthcare of Atlanta patients
  • January 1, 2002 through June 20, 2006
  • \< 30 days of age
  • neurological complications following cardiac surgery

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

    Sibley Heart Center Cardiology at 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

April 1, 2010

Study Completion

April 1, 2010

Last Updated

December 2, 2014

Record last verified: 2014-11

Locations

US(1)