Immune Suppression Of Infants Treated With Steroids
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Purpose
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 |
|---|---|
|
Hemangioma |
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 |
- Lymphocyte Subtest of Complete Blood Count Analysis (Primary Immunodeficiency) [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]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.
Eligibility| Ages Eligible for Study: | up to 6 Months |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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| United States, Wisconsin | |
| Children's Hospital of Wisconsin | |
| Milwaukee, Wisconsin, United States, 53226 | |
| Principal Investigator: | Beth A Drolet, MD | Medical College of Wisconsin |
More Information
No publications provided
| Responsible Party: | Beth Drolet, MD, Medical College of Wisconsin |
| ClinicalTrials.gov Identifier: | NCT00433940 History of Changes |
| Other Study ID Numbers: | Immune Suppression of Infants |
| Study First Received: | February 9, 2007 |
| Last Updated: | January 23, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Medical College of Wisconsin:
|
Hemangioma Corticosteroid Prednisone |
Additional relevant MeSH terms:
|
Hemangioma Neoplasms, Vascular Tissue Neoplasms by Histologic Type Neoplasms Methylprednisolone acetate Prednisolone acetate Prednisolone Methylprednisolone Methylprednisolone Hemisuccinate Prednisolone hemisuccinate Prednisolone phosphate Sodium phosphate Anti-Inflammatory Agents Therapeutic Uses Pharmacologic Actions |
Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Antineoplastic Agents, Hormonal Antineoplastic Agents Antiemetics Autonomic Agents Peripheral Nervous System Agents Central Nervous System Agents Gastrointestinal Agents Neuroprotective Agents Protective Agents Cathartics |
ClinicalTrials.gov processed this record on June 17, 2013