Immune Suppression Of Infants Treated With Steroids

• Sponsor: Medical College of Wisconsin (Other)
• Overall Status: Completed
• CT.gov ID: NCT00433940
• Collaborator: (none)
• Enrollment: 16
• Location: 1
• Duration (Months): 45
• Patients Per Site Per Month: 0.4

Study Details

Study Description

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	Phase
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

• 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: Oct 1, 2006
• Actual Primary Completion Date: Apr 1, 2008
• Actual Study Completion Date: Jul 1, 2010

Arms and Interventions

Arm	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 Names: steroid

Outcome Measures

Primary Outcome Measures

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 6 Months
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Beth Drolet, MD, Medical College of Wisconsin
• ClinicalTrials.gov Identifier: NCT00433940
• Other Study ID Numbers: Immune Suppression of Infants
• First Posted: Feb 12, 2007
• Last Update Posted: Jan 24, 2013
• Last Verified: Jan 1, 2013

• Keywords provided by Beth Drolet, MD, Medical College of Wisconsin: Hemangioma; Corticosteroid; Prednisone
• Additional relevant MeSH terms: Hemangioma; Prednisolone

Study Results

No Results Posted as of Jan 24, 2013