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


- candidate number2359
- NTR NumberNTR832
- ISRCTNISRCTN14013064
- Date ISRCTN created16-jan-2007
- date ISRCTN requested29-dec-2006
- Date Registered NTR7-dec-2006
- Secondary IDsN/A 
- Public TitleIntravenous immunoglobuline in the treatment of Rhesus disease of the neonate. A randomized double blind placebo controlled trial.
- Scientific TitleIntravenous immunoglobuline in the treatment of Rhesus disease of the neonate. A randomized double blind placebo controlled trial.
- ACRONYMLIVIN
- hypothesisA randomized double blind placebo controlled trial for the use of intravenous immunoglobulin to reduce the number of exchange transfusions in Rhesus disease of the neonate.
- Healt Condition(s) or Problem(s) studiedRhesus disease
- Inclusion criteriaNeonates 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 criteria1. 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.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type[default]
- Studytypeintervention
- planned startdate 1-aug-2006
- planned closingdate31-jul-2009
- Target number of participants80
- InterventionsStudy 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).
- Primary outcome1. Use of exchange transfusion (%; proportion of children receiving one or more exchange transfusion); 2. Number of exchange transfusion performed per infant.
- Secondary outcome1. 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).
- Timepoints
- Trial web siteN/A
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIESMD., PhD. E. Lopriore
- CONTACT for SCIENTIFIC QUERIESMD., PhD. E. Lopriore
- Sponsor/Initiator Leiden University Medical Center (LUMC), Department of Pediatrics Division of Neonatology, J6-S
- Funding
(Source(s) of Monetary or Material Support)
Sanquin Bloodbank Amsterdam
- PublicationsN/A
- Brief summaryTraditional neonatal treatment of Rhesus (Rh) hemolytic disease consists of intensive phototherapy and exchange transfusions (ET). Recently, routine use of intravenous immunoglobulin (IVIg) has been recommended to reduce the number of ET. However, the evidence to recommend prophylactic treatment with IVIg is limited. The aim of this study is to determine whether the prophylactic use of IVIg reduces the need for ET in neonates with Rh (D) or (c) hemolytic disease. The study design is a prospective randomized double blind placebo controlled trial. All neonates born at our hospital after 35 weeks’ gestation and affected with Rh (D) or (c) disease are eligible for the study. After parental informed consent and randomization, neonates will receive conventional treatment + IVIg (0.75 g/kg) or conventional treatment alone. Primary outcome is the proportion of children requiring ET and number of ET performed per infant. Secondary outcomes are duration of phototherapy and hospital stay, serum bilirubin levels (maximum values and change within first 24 and 48 hours), proportion of children requiring top-up red cell transfusion within the first three months of life and the number of red cell transfusions per infant.
- Main changes (audit trail)
- RECORD7-dec-2006 - 23-sep-2010


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