Intravenous immunoglobuline in the treatment of Rhesus disease of the neonate. A randomized double blind placebo controlled trial.

eiden University Medical Center (LUMC), Department of Neonatology0 个研究点目标入组 80 人开始时间: 待定最近更新: 2024年2月28日

适应症

试验速览

•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) > 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.

•1. Perinatal asphyxia (defined as an Apgar score at 5 minutes less than 3 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 > 24 hours after birth.

发起方

eiden University Medical Center (LUMC), Department of Neonatology