Children's Hospital of Wisconsin
Milwaukee, Wisconsin, 53226, United States
NCT Number: NCT00433940
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.
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All sexes
Observational
Milwaukee, Wisconsin, 53226, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Oral prednisolone sodium phosphate suspension administered in dosage of 15mg/5mL. Medication administered every morning at a starting daily dose of 2.5mg/kg.
Other names: steroid
Time frame: 2 years
Measurement of absolute lymphocyte count and % lymphocyte found during a Complete Blood Count analysis.
Medical College of Wisconsin
Other
Immune Suppression of Infants Treated With Oral Corticosteroids for Infantile Hemangiomas: A Pilot Study
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