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临床试验/NCT01880801
NCT01880801Unknown不适用

IMMUNOGLOBULINS ANTI PLATELETS IN BREAST MILK OF MATERNAL ITP

Laniado Hospital1 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2013年8月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
22
试验地点
1
主要终点
IMMUNOGLOBULINS ANTI PLAITLETS IN BREST MILK OF MATERNAL ITP

研究概览

简要总结

The purpose of this study is to determine whether mothers with Idiopathic thrombocytopenic purpura (ITP) has antibodies against platelets in breastfeeding milk aside control group of healthy mothers.

In order to prevent severe thrombocytopenia in infants born to mothers with ITP.

详细描述

Samples of breastfeeding milk and sera will be collected from 10 lactating women diagnosed with ITP and from 10 healthy women in the same stage after giving birth. Antibodies against platelets in the samples will be examined by using anti human IgM/G/A antibody following incubation of the serum/milk samples with platelets. The platelets will be from leftovers of samples send to platelets functionality test and found to be normal (the platelets samples will be taken without any identification and be marked only with lab number). The measurement will be done by flow cytometer. Sample will be consider as positive when the signal will be greater than 2 fold of control samples standard deviation. In addition, the presence of antibodies in different times from the birth will be checked in breastfeeding milk and sera of ITP patients. If the milk proteins and lipids will disturb the exam, the immunoglobulins from the milk will be isolated using Ig isolation kit from plasma.

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
18 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Maternal ITP
  • Newborns above 35W and above 2.5 kg

排除标准

  • mothers who do not breast feeding
  • Thrombocytopenia from other reasons

结局指标

主要结局

IMMUNOGLOBULINS ANTI PLAITLETS IN BREST MILK OF MATERNAL ITP

时间窗: 4 times in the first month after delivery

次要结局

未报告次要终点

研究者

发起方
Laniado Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Laniado Hospital

pediatric hemato-oncology

Laniado Hospital

研究点 (1)

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