Immune Suppression Of Infants Treated With Steroids

Hemangioma Clinical Trial

Official title:

Immune Suppression of Infants Treated With Oral Corticosteroids for Infantile Hemangiomas: A Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00433940
• Other study ID #: Immune Suppression of Infants
• Status: Completed
• Phase: N/A
• First received: February 9, 2007
• Last updated: January 23, 2013
• Start date: October 2006
• Est. completion date: July 2010

Study information

• Verified date: January 2013
• Source: Medical College of Wisconsin
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: July 2010
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 6 Months

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hemangioma

Intervention

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.

Locations

Country	Name	City	State
United States	Children's Hospital of Wisconsin	Milwaukee	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Medical College of Wisconsin

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lymphocyte Subtest of Complete Blood Count Analysis (Primary Immunodeficiency)	Measurement of absolute lymphocyte count and % lymphocyte found during a Complete Blood Count analysis.	2 years	Yes