An observational study in Hemangioma, sponsored by Medical College of Wisconsin. Completed at 1 site in United States. Open to participants aged Up to 6 Months. Per ClinicalTrials.gov, last updated 2013-01-24.
Sponsored by Medical College of Wisconsin · Observational
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.
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.
141 studies on the registry are indexed under Hemangioma; 16 are open to participants now.
This study's enrollment of 16 is below the median of 79 across 56 observational studies indexed under Hemangioma.
Browse Hemangioma studies →Medical College of Wisconsin is the lead sponsor of 540 studies on the registry; 120 are open to participants now.
Of its 71 completed or terminated interventional studies of FDA-regulated products, 56 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Subjects were recruited from a hospital based pediatric dermatology clinic.
Exclusion Criteria:
Infants with infantile hemangioma being treated clinically with oral prednisolone sodium phosphate suspensions.
Drug: Prednisolone
Oral prednisolone sodium phosphate suspension administered in dosage of 15mg/5mL. Medication administered every morning at a starting daily dose of 2.5mg/kg.
Also known as: steroid
Lymphocyte Subtest of Complete Blood Count Analysis (Primary Immunodeficiency)
Measurement of absolute lymphocyte count and % lymphocyte found during a Complete Blood Count analysis.
Time frame: 2 years
This study is completed, as verified in Jan 2013. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Medical College of Wisconsin