Condition category
Pregnancy and Childbirth
Date applied
16/01/2007
Date assigned
16/01/2007
Last edited
17/01/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.lumc.nl/

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

Publication citations

Additional files

Editorial Notes