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Immune Suppression Of Infants Treated With Steroids

This study has been completed.
Information provided by (Responsible Party):
Beth Drolet, Medical College of Wisconsin Identifier:
First received: February 9, 2007
Last updated: January 23, 2013
Last verified: January 2013
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.

Condition Intervention
Drug: Prednisolone

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Immune Suppression of Infants Treated With Oral Corticosteroids for Infantile Hemangiomas: A Pilot Study

Resource links provided by NLM:

Further study details as provided by Medical College of Wisconsin:

Primary Outcome Measures:
  • Lymphocyte Subtest of Complete Blood Count Analysis (Primary Immunodeficiency) [ Time Frame: 2 years ]
    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.

Enrollment: 16
Study Start Date: October 2006
Study Completion Date: July 2010
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Infantile Hemangioma Patients
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.
Other Name: steroid

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.

Ages Eligible for Study:   up to 6 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects were recruited from a hospital based pediatric dermatology clinic.

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00433940

United States, Wisconsin
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
Medical College of Wisconsin
Principal Investigator: Beth A Drolet, MD Medical College of Wisconsin
  More Information

Responsible Party: Beth Drolet, MD, Medical College of Wisconsin Identifier: NCT00433940     History of Changes
Other Study ID Numbers: Immune Suppression of Infants
Study First Received: February 9, 2007
Last Updated: January 23, 2013

Keywords provided by Medical College of Wisconsin:

Additional relevant MeSH terms:
Neoplasms, Vascular Tissue
Neoplasms by Histologic Type
Prednisolone acetate
Methylprednisolone acetate
Methylprednisolone Hemisuccinate
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Neuroprotective Agents
Protective Agents processed this record on April 27, 2017