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

6 Months
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Trial Information

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

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.

Inclusion Criteria:

- Infants < 6 months of age with infantile hemangiomas requiring treatment with oral

- 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

- Infants with know immunodeficiencies

- Infants receiving other oral medications for the treatment of hemangiomas

Type of Study:


Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Lymphocyte Subtest of Complete Blood Count Analysis (Primary Immunodeficiency)

Outcome Description:

Measurement of absolute lymphocyte count and % lymphocyte found during a Complete Blood Count analysis.

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Beth A Drolet, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Medical College of Wisconsin


United States: Institutional Review Board

Study ID:

Immune Suppression of Infants



Start Date:

October 2006

Completion Date:

July 2010

Related Keywords:

  • Hemangioma
  • Hemangioma
  • Corticosteroid
  • Prednisone
  • Hemangioma



Children's Hospital of Wisconsin Milwaukee, Wisconsin  53201