Immune Suppression of Infants Treated With Oral Corticosteroids for Infantile Hemangiomas: A Pilot Study
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.
Observational
Observational Model: Cohort, Time Perspective: Prospective
Lymphocyte Subtest of Complete Blood Count Analysis (Primary Immunodeficiency)
Measurement of absolute lymphocyte count and % lymphocyte found during a Complete Blood Count analysis.
2 years
Yes
Beth A Drolet, MD
Principal Investigator
Medical College of Wisconsin
United States: Institutional Review Board
Immune Suppression of Infants
NCT00433940
October 2006
July 2010
Name | Location |
---|---|
Children's Hospital of Wisconsin | Milwaukee, Wisconsin 53201 |