Intravenous immunoglobulin in the treatment of rhesus disease of the neonate: a randomised double blind placebo controlled trial

Not Applicable

Completed

• Conditions: Rhesus disease; Pregnancy and Childbirth; Foetal problems

• Registration Number: ISRCTN14013064
• Lead Sponsor: eiden University Medical Center (LUMC) (The Netherlands)

Brief Summary

2011 results in https://pubmed.ncbi.nlm.nih.gov/21422084/ (added 14/01/2021)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-01-16
• Study Completion: 2009-07-31
• Last Update Posted: 25 January 2021

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) more than 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 five minutes less than three 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 more than 24 hours after birth

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
<br> 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 three 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)<br>