Rhesus disease, fetal, neonatal
Conditions
Interventions
Study group: prophylactic IvIG as a single dose of 0.75 g/kg within the first 4 hours after birth
Control group: an equal amount of glucose 5% intravenous infusion (placebo).
Sponsors
Leiden University Medical Center (LUMC), Department of Neonatology
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Use of exchange transfusion (%; proportion of children receiving one or more exchange transfusion); 2. Number of exchange transfusion performed per infant. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Duration of phototherapy (number of days); 2. Maximum serum bilirubin (mmol/l); 3. Change in bilirubin in first 24 hours (%); 4. Change in bilirubin in first 48 hours (%); 5. Use of top-up red cell transfusion in first week of life (%; proportion of children receiving one or more red cell transfusion and number of transfusions per infant); 6. Use of simple red cell transfusion after first week and until 3 months of life (%; proportion of children receiving one or more red cell transfusion and number of transfusions per infant); 7. Duration of hospital stay (number of days). | — |
Contacts
Public ContactE. Lopriore
Leiden University Medical Center (LUMC), Department of Pediatrics Division of Neonatology, J6-S P.O. Box 9600
Outcome results
None listed