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Growth in Children With HLHS

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ClinicalTrials.gov Identifier: NCT00277992
Recruitment Status : Terminated
First Posted : January 18, 2006
Last Update Posted : May 23, 2007
Sponsor:
Information provided by:
Children's Healthcare of Atlanta

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.


Condition or disease
Congenital Disorders

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.


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Study Type : Observational
Enrollment : 100 participants
Observational Model: Defined Population
Observational Model: Natural History
Time Perspective: Longitudinal
Time Perspective: Retrospective
Official Title: Growth in Children With HLHS
Study Start Date : January 2001




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Ages Eligible for Study:   up to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00277992


Locations
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United States, Georgia
Children's Healthcare of Atlanta
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Children's Healthcare of Atlanta
Investigators
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Principal Investigator: Janet Simsic, MD Children's Healthcare of Atlanta, Sibley Heat Center Cardiology

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ClinicalTrials.gov Identifier: NCT00277992     History of Changes
Other Study ID Numbers: 05-107
First Posted: January 18, 2006    Key Record Dates
Last Update Posted: May 23, 2007
Last Verified: May 2007

Keywords provided by Children's Healthcare of Atlanta:
Pediatric
Cardiac
Norwood operation modification
GT/Nissen operation
Po feed
GT fed