Ignite Creation Date:
2024-05-05 @ 4:37 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00277992
Status:
TERMINATED
Last Update Posted:
2007-05-23
First Post:
2006-01-13
Brief Title:
Growth in Children With HLHS
Sponsor:
Childrens Healthcare of Atlanta
Organization:
Childrens Healthcare of Atlanta
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 GTNissen 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:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None