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

ISRCTN	ISRCTN14013064
DOI	https://doi.org/10.1186/ISRCTN14013064
Protocol serial number	NL819, NTR832
Sponsor	Leiden University Medical Center (LUMC) (The Netherlands)
Funder	Sanquin Bloodbank Amsterdam (The Netherlands)

Submission date: 16/01/2007
Registration date: 16/01/2007
Last edited: 14/01/2021

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Pregnancy and Childbirth

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr E Lopriore
Scientific

Leiden University Medical Center (LUMC)
Department of Pediatrics Division of Neonatology, J6-S
P.O. Box 9600
Leiden
2300 RC
Netherlands

Phone	+31 (0)71 526 2909
Email	e.lopriore@lumc.nl

Study information

Primary study design	Interventional
Study design	Randomised, placebo controlled, parallel group, double blinded trial
Secondary study design	Randomised controlled trial
Scientific title	Intravenous immunoglobulin in the treatment of rhesus disease of the neonate: a randomised double blind placebo controlled trial
Study acronym	LIVIN
Study objectives	A randomised double blind placebo controlled trial for the use of Intravenous ImmunoGlobulin (IvIG) to reduce the number of exchange transfusions in Rhesus disease of the neonate.
Ethics approval(s)	Approval received from the Medical Ethics Committee of the Leiden University Medical Center on the 12th May 2006 (ref: P06.049).
Health condition(s) or problem(s) studied	Rhesus disease
Intervention	Study group: prophylactic IvIG as a single dose of 0.75 g/kg within the first four hours after birth. Control group: an equal amount of glucose 5% intravenous infusion (placebo).
Intervention type	Drug
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Prophylactic IvIG and glucose 5% intravenous infusion
Primary outcome measure(s)	1. Use of exchange transfusion (% proportion of children receiving one or more exchange transfusion) 2. Number of exchange transfusion performed per infant
Key secondary outcome measure(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 three 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)
Completion date	31/07/2009

Eligibility

Participant type(s)	Patient
Age group	Neonate
Sex	Not Specified
Target sample size at registration	80
Key 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
Key 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
Date of first enrolment	01/08/2006
Date of final enrolment	31/07/2009

Locations

Countries of recruitment

Netherlands

Study participating centre

Leiden University Medical Center (LUMC)

Leiden
2300 RC
Netherlands

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/04/2011	14/01/2021	Yes	No

Editorial Notes

14/01/2021: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
3. The NTR numbers have been added.