Contact information
Type
Scientific
Primary contact
Dr E Lopriore
ORCID ID
Contact details
Leiden University Medical Center (LUMC)
Department of Pediatrics Division of Neonatology
J6-S
P.O. Box 9600
Leiden
2300 RC
Netherlands
+31 (0)71 526 2909
e.lopriore@lumc.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
LIVIN
Study hypothesis
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
Approval received from the Medical Ethics Committee of the Leiden University Medical Center on the 12th May 2006 (ref: P06.049).
Study design
Randomised, placebo controlled, parallel group, double blinded trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
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 names
Prophylactic IvIG and glucose 5% intravenous infusion
Primary outcome measures
1. Use of exchange transfusion (% proportion of children receiving one or more exchange transfusion)
2. Number of exchange transfusion performed per infant
Secondary outcome measures
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)
Overall trial start date
01/08/2006
Overall trial end date
31/07/2009
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Neonate
Gender
Not Specified
Target number of participants
80
Participant 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
Recruitment start date
01/08/2006
Recruitment end date
31/07/2009
Locations
Countries of recruitment
Netherlands
Trial participating centre
Leiden University Medical Center (LUMC)
Leiden
2300 RC
Netherlands
Sponsor information
Organisation
Leiden University Medical Center (LUMC) (The Netherlands)
Sponsor details
Department of Pediatrics Division of Neonatology
J6-S
P.O. Box 9600
Leiden
2300 RC
Netherlands
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Sanquin Bloodbank Amsterdam (The Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary