ISRCTN14013064已完成未知
Intravenous immunoglobulin in the treatment of rhesus disease of the neonate: a randomised double blind placebo controlled trial
eiden University Medical Center (LUMC) (The Netherlands)0 个研究点目标入组 80 人开始时间: 2007年1月16日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 80
研究概览
简要总结
2011 results in https://pubmed.ncbi.nlm.nih.gov/21422084/ (added 14/01/2021)
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Neonates of 35 or more weeks of gestation with Rhesus hemolytic disease admitted to the neonatal nursery of the Leiden University Medical Center (LUMC). Rhesus hemolytic disease was defined as:
- •1. Antibody Dependent Cellular Cytotoxicity-test (ADCC) more than 50%, and
- •2. Positive direct Coombs test in a Rh (D) or (c) positive fetus/neonate with a Rh (D) or (c) negative mother respectively and a Rh (D) or (c) positive father respectively. Previous intra-uterine transfusions and the presence of additional antibodies besides anti-D and anti-c are not reasons for exclusion
排除标准
- •1. Perinatal asphyxia (defined as an Apgar score at five minutes less than three and/or umbilical cord arterial pH less than 7.0)
- •2. Neonates with hemolytic disease other than Rh (D) or (c)
- •3. Neonates with Rh hemolytic disease presenting more than 24 hours after birth
研究者
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