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NCT00277992 Clinical Trial

Growth in Children With HLHS

Congenital Disorders Clinical Trial

Official title:
Growth in Children With HLHS

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00277992
Other study ID # 05-107
Secondary ID
Status Terminated
Phase N/A
First received January 13, 2006
Last updated May 22, 2007
Start date January 2001

Study information
Verified date May 2007
Source Children's Healthcare of Atlanta
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Terminated
Enrollment 100
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group N/A to 21 Years
Eligibility 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

Study Design

Observational Model: Defined Population, Time Perspective: Longitudinal

Related Conditions & MeSH terms

Locations
Country Name City State
United States Children's Healthcare of Atlanta Atlanta Georgia

Sponsors (1)
Lead Sponsor Collaborator
Children's Healthcare of Atlanta

Country where clinical trial is conducted

United States, 

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