eiden's IVIg trial in Rhesus disease of the Neonate
- Conditions
- Rhesus disease100189111000533010028920
- Registration Number
- NL-OMON29923
- Lead Sponsor
- Academisch Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 68
7.1 Neonates of 35 or more weeks of gestation with Rh-D hemolytic disease admitted to the neonatal nursery of the Leiden University Medical Center (LUMC). Rh-D hemolytic disease was defined as (1) Antibody Dependent Cellular Cytotoxicity-test (ADCC) > 50% and (2) positive direct Coombs test in a Rh-D positive fetus/neonate with a Rh-D negative mother and a Rh-D positive father. Previous intra-uterine transfusions and the presence of additional antibodies besides anti-D are not reasons for exclusion.
7.2 (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. (3) Neonates with Rh-D hemolytic disease presenting > 24 hours after birth.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method