Clinical Trial: Immune Suppression Of Infants Treated With Steroids

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Immune Suppression of Infants Treated With Oral Corticosteroids for Infantile Hemangiomas: A Pilot Study

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 Summary: 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 infant's 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.
Sponsor: Medical College of Wisconsin

Current Primary Outcome: Lymphocyte Subtest of Complete Blood Count Analysis (Primary Immunodeficiency) [ Time Frame: 2 years ]

Measurement of absolute lymphocyte count and % lymphocyte found during a Complete Blood Count analysis.


Original Primary Outcome: Lymphocyte Subset Analysis (Primary Immunodeficiency)

Current Secondary Outcome:

Original Secondary Outcome:

  • Tetanus Antibody
  • Diptheria Antibody


Information By: Medical College of Wisconsin

Dates:
Date Received: February 9, 2007
Date Started: October 2006
Date Completion:
Last Updated: January 23, 2013
Last Verified: January 2013