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

Completed

Conditions: Rhesus disease, fetal, neonatal

Registration Number: NL-OMON25873

Lead Sponsor: eiden University Medical Center (LUMC), Department of Neonatology

Brief Summary: /A

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 80

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

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Use of exchange transfusion (%; proportion of children receiving one or more exchange transfusion);<br>2. Number of exchange transfusion performed per infant.

Secondary Outcome Measures

Name	Time	Method
1. Duration of phototherapy (number of days);<br>2. Maximum serum bilirubin (mmol/l);<br>3. Change in bilirubin in first 24 hours (%);<br>4. Change in bilirubin in first 48 hours (%);<br>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);<br>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);<br>7. Duration of hospital stay (number of days).