Immune Suppression Of Infants Treated With Steroids
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About
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.
Full 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 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.
Enrollment
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Inclusion criteria
- Infants < 6 months of age with infantile hemangiomas requiring treatment with oral corticosteroids
- Infant must be enrolled prior to initiation of steroid therapy
Exclusion criteria
- Infants > 6 months of age
- Infants already receiving oral corticosteroid treatment prior to the start of this study
- Infants with know immunodeficiencies
- Infants receiving other oral medications for the treatment of hemangiomas
Trial design
16 participants in 1 patient group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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