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

• Register: Netherlands Trial Register
• Last refreshed on: 28 April 2013
• Main ID: NTR832
• Date of registration: 07/12/2006
• Primary sponsor: Leiden University Medical Center (LUMC), Department of Pediatrics Division of Neonatology, J6-S
• Public title: Intravenous immunoglobuline in the treatment of Rhesus disease of the neonate. A randomized double blind placebo controlled trial.
• Scientific title: Intravenous immunoglobuline in the treatment of Rhesus disease of the neonate. A randomized double blind placebo controlled trial. - LIVIN
• Date of first enrolment: 1/8/2006
• Target sample size: 80
• Recruitment status: complete
• URL: http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=832
• Study type: intervention
• Study design: Randomised: Yes; Masking: Double; Control: Placebo; Group: Parallel; Type: [default]

Countries of recruitment

The Netherlands

Contacts

• Name: E. Lopriore

• Name: E. Lopriore

Key inclusion & exclusion 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: 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.

Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Rhesus disease

Intervention(s)

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).

Primary Outcome(s)

1. Use of exchange transfusion (%; proportion of children receiving one or more exchange transfusion);
2. Number of exchange transfusion performed per infant.

Secondary Outcome(s)

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).

Secondary ID(s)

ISRCTN14013064

N/A

Source(s) of Monetary Support

Sanquin Bloodbank Amsterdam