Growth in Children With HLHS

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00277992

Enrollment

100

Registered

2006-01-18

Start date

2001-01-31

Completion date

Unknown

Last updated

2007-05-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Congenital Disorders

Keywords

Pediatric, Cardiac, Norwood operation modification, GT/Nissen operation, Po feed, GT fed

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.

Detailed description

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. Also, the standard of care has changed to GT/Nissen operation to facilitate safe feeding in those patients who are not able to feed by mouth (po feed). A second aim of this study is to evaluate whether children who are GT fed have improved growth compared to those who are not. We wish to review all patients who underwent Norwood procedure from January 1, 2001 to March 31, 2005.

Interventions

None listed

Study design

Observational model

DEFINED_POPULATION

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

No minimum to 21 Years

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

* Those who do not meet inclusion criteria

Countries

United States

Outcome results