Immune Suppression Of Infants Treated With Steroids
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.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Immune Suppression of Infants Treated With Oral Corticosteroids for Infantile Hemangiomas: A Pilot Study|
- Lymphocyte Subtest of Complete Blood Count Analysis (Primary Immunodeficiency) [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]Measurement of absolute lymphocyte count and % lymphocyte found during a Complete Blood Count analysis.
Biospecimen Retention: None Retained
Collection of blood samples at each visit. Following laboratory testing, no samples were retained.
|Study Start Date:||October 2006|
|Study Completion Date:||July 2010|
|Primary Completion Date:||April 2008 (Final data collection date for primary outcome measure)|
Infantile Hemangioma Patients
Infants with infantile hemangioma being treated clinically with oral prednisolone sodium phosphate suspensions.
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 Name: steroid
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00433940
|United States, Wisconsin|
|Children's Hospital of Wisconsin|
|Milwaukee, Wisconsin, United States, 53226|
|Principal Investigator:||Beth A Drolet, MD||Medical College of Wisconsin|