Ignite Creation Date:
2024-05-05 @ 5:21 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00433940
Status:
COMPLETED
Last Update Posted:
2013-01-24
First Post:
2007-02-09
Brief Title:
Immune Suppression Of Infants Treated With Steroids
Sponsor:
Medical College of Wisconsin
Organization:
Medical College of Wisconsin
Study Overview
Official Title:
Immune Suppression of Infants Treated With Oral Corticosteroids for Infantile Hemangiomas A Pilot Study
Status:
COMPLETED
Status Verified Date:
2013-01
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:
The goal of this study is to clarify the degree of immune suppression in infants requiring therapy and to create guidelines for evaluation and prevention of infection in infants on oral steroids for hemangiomas
Detailed Description:
Infants with large or complicated hemangiomas are often treated systemically with oral steroids The side effects of the drug on young infants has not been studied The goal of this study is to clarify the degree of immune suppression in infants requiring therapy and to create guidelines for evaluation and prevention of infection in infants on oral steroids for hemangiomas Prednisone will be started according to established standard of care Visits will occur every four weeks for follow-up There will be six blood draws from baseline to completion of study Approximately up to 1 ½ teaspoons per blood sample will be drawn to test the strength of the infants immune system Participation in this study will last up to 14 months or until stabilization of the hemangioma Evaluation will occur 12 weeks after discontinuing the steroid for its long-term effects on the immune system
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