Immune Suppression Of Infants Treated With Steroids

Study Description

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment
Hemangioma	Drug: Prednisolone

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 Design

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Study Type :	Observational
Actual Enrollment :	16 participants
Observational Model:	Cohort
Time Perspective:	Prospective
Official Title:	Immune Suppression of Infants Treated With Oral Corticosteroids for Infantile Hemangiomas: A Pilot Study
Study Start Date :	October 2006
Actual Primary Completion Date :	April 2008
Actual Study Completion Date :	July 2010

Groups and Cohorts

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Group/Cohort	Intervention/treatment
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

Outcome Measures

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. 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.

Eligibility Criteria

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Criteria

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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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

United States, Wisconsin
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, United States, 53226

Sponsors and Collaborators

Medical College of Wisconsin

Investigators

Principal Investigator:	Beth A Drolet, MD	Medical College of Wisconsin

More Information

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Beth Drolet, MD, Medical College of Wisconsin
ClinicalTrials.gov Identifier:	NCT00433940 History of Changes
Other Study ID Numbers:	Immune Suppression of Infants
First Posted:	February 12, 2007
Last Update Posted:	January 24, 2013
Last Verified:	January 2013

Keywords provided by Beth Drolet, Medical College of Wisconsin:

Hemangioma; Corticosteroid; Prednisone

Additional relevant MeSH terms:

Hemangioma; Neoplasms, Vascular Tissue; Neoplasms by Histologic Type; Neoplasms; Prednisolone acetate; Methylprednisolone acetate; Prednisolone; Methylprednisolone; Methylprednisolone Hemisuccinate; Prednisolone hemisuccinate; Prednisolone phosphate; Anti-Inflammatory Agents	Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Antineoplastic Agents, Hormonal; Antineoplastic Agents; Antiemetics; Autonomic Agents; Peripheral Nervous System Agents; Gastrointestinal Agents; Neuroprotective Agents; Protective Agents