Immune Suppression Of Infants Treated With Steroids

Completed

• Conditions: Hemangioma
• Interventions: Drug: Prednisolone

• Registration Number: NCT00433940
• Lead Sponsor: Medical College of Wisconsin

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2006-10
• Study First Submitted: 2007-02-09
• Study First Submitted QC: 2007-02-09
• Study First Posted: 2007-02-12
• Primary Completion: 2008-04
• Study Completion: 2010-07
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-23
• Last Update Posted: 2013-01-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Infantile Hemangioma Patients	Prednisolone	Infants with infantile hemangioma being treated clinically with oral prednisolone sodium phosphate suspensions.

Primary Outcome Measures

Name	Time	Method
Lymphocyte Subtest of Complete Blood Count Analysis (Primary Immunodeficiency)	2 years	Measurement of absolute lymphocyte count and % lymphocyte found during a Complete Blood Count analysis.

Trial Locations

Locations (1)

Children's Hospital of Wisconsin; 🇺🇸 Milwaukee, Wisconsin, United States