IMMUNOGLOBULINS ANTI PLATELETS IN BREAST MILK OF MATERNAL ITP
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
- 否
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
Laniado Hospital
pediatric hemato-oncology
Laniado Hospital
