NCT00277992

Brief Summary

Children with HLHS have a history of poor enteral intake and growth. Over the past several years a modification to the Norwood operation was instituted (RV to PA shunt in place of the standard Blalock-Taussig shunt). The purpose of this study is to evaluate whether children who underwent this modification of the Norwood procedure had improved growth compared to those in past years who underwent traditional Norwood.

Trial Health

35
At Risk

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

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

January 1, 2001

Completed
5 years until next milestone

First Submitted

Initial submission to the registry

January 13, 2006

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 18, 2006

Completed
Last Updated

May 23, 2007

Status Verified

May 1, 2007

First QC Date

January 13, 2006

Last Update Submit

May 22, 2007

Conditions

Keywords

PediatricCardiacNorwood operation modificationGT/Nissen operationPo feedGT fed

Eligibility Criteria

AgeUp to 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Patient at Children's Healthcare of Atlanta, Egleston Norwood procedure between Jan. 1. 2001 and March 31.2005

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 Simsic, MD

    Children's Healthcare of Atlanta, Sibley Heat Center Cardiology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
DEFINED POPULATION
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 13, 2006

First Posted

January 18, 2006

Study Start

January 1, 2001

Last Updated

May 23, 2007

Record last verified: 2007-05

Locations