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临床试验/NCT00433940
NCT00433940已完成不适用

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

Medical College of Wisconsin1 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2006年10月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
16
试验地点
1
主要终点
Lymphocyte Subtest of Complete Blood Count Analysis (Primary Immunodeficiency)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
— 至 6 Months(Child)
性别
All
接受健康志愿者

入选标准

  • Infants < 6 months of age with infantile hemangiomas requiring treatment with oral corticosteroids
  • Infant must be enrolled prior to initiation of steroid therapy

排除标准

  • 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

研究组 & 干预措施

Infantile Hemangioma Patients

Infants with infantile hemangioma being treated clinically with oral prednisolone sodium phosphate suspensions.

干预措施: Prednisolone (Drug)

结局指标

主要结局

Lymphocyte Subtest of Complete Blood Count Analysis (Primary Immunodeficiency)

时间窗: 2 years

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

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Beth Drolet

MD

Medical College of Wisconsin

研究点 (1)

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