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临床试验/NCT05617612
NCT05617612尚未招募不适用

Neonatal Alloantibodies in Cord Blood for Early Detection of Hemolytic Disease of Newborn

Assiut University0 个研究点目标入组 400 人开始时间: 2022年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
400
主要终点
evaluate the diagnostic efficiency of antibodies screening in cord blood for detection of HDN

研究概览

简要总结

To evaluate the diagnostic efficiency of antibodies screening in cord blood for detection of HDN.

To help finding the antigen negative blood in a timely manner and reduce the morbidities and mortalities of HDN

详细描述

Hemolytic disease of the newborn (HDN) refers to fetal or neonatal alloimmune hemolysis caused by red blood cell antibodies due to incompatible maternal and fetal or neonatal blood types. A French midwife first described the disorder in 1609; however, it was not until the 1950s when the underlying cause was clarified. The pathogenesis of HDN begins with the attack of fetal red blood cells (RBCs) by maternal antibodies due to incompatibility of maternal and fetal blood. Immunologically, antibody secretion initially starts with Immunoglobulin M (IgM), which cannot cross the placental barrier, but is then followed by isotype switching, which produces Immunoglobulin G (IgG) antibodies. IgG antibodies can cross the placental barrier, and they do so during the second and or subsequent pregnancies, attacking the fetal RBCs and causing hemolysis and associated complications such as Hydrops fetalis and jaundice. HDN can occur due to Rh antigens, most commonly the D antigen, and A,B and O RBCs antigens (ABO) antigens. Rh(D)-HDN has decreased since the introduction of antenatal and postpartum Rh immunoglobulin. Therefore, the prevalence of HDN, nowadays, varies according to blood type incompatibility. ABO incompatibility is the most common cause of HDN and Rh (D) antigen is the second most common cause.[8] Rh (C, c, E, e) antigen incompatibility occurs occasionally. Several other alloantibodies have also been reported to be associated with hemolytic diseases, including Kidd, Diego, Duffy, Kell and Anti-Mur. Minor blood group incompatibility due to blood groups other than Rh(D), although an uncommon cause of neonatal hyperbilirubinemia, has the potential to cause severe hyperbilirubinemia and its sequelae in infants, if left undiagnosed and untreated. Therefore, identification of at-risk cases will help clinicians to reduce neonatal morbidity and will result in better patient management

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
1 Day 至 3 Days(Child)
性别
All
接受健康志愿者

入选标准

  • Full term neonates >/= 37 weeks.
  • ABO blood compatible mother and neonate

排除标准

  • Preterm neonates < 37 weeks.
  • ABO incompatibility between mother and neonate

结局指标

主要结局

evaluate the diagnostic efficiency of antibodies screening in cord blood for detection of HDN

时间窗: Baseline

Early detection of HDN through antibodies screening would help finding the antigen negative blood in a timely manner and reduce the morbidities and mortalities

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

Shimaaa Abd El-Aleem

Neonatal Alloantibodies in cord blood for early detection of Hemolytic disease of newborn

Assiut University

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