Ignite Creation Date:
2025-12-24 @ 3:55 PM
Ignite Modification Date:
2025-12-27 @ 5:00 AM
Study NCT ID:
NCT00277992
Status:
TERMINATED
Last Update Posted:
2007-05-23
First Post:
2006-01-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Growth in Children With HLHS
Sponsor:
Children's Healthcare of Atlanta
Organization:
Study Overview
Official Title:
Growth in Children With HLHS
Status:
TERMINATED
Status Verified Date:
2007-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: