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 |
| Secondary identifying numbers | NL819, NTR832 |
- 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
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 |
|---|---|
| e.lopriore@lumc.nl |
Study information
| Study design | Randomised, placebo controlled, parallel group, double blinded trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Prophylactic IvIG and glucose 5% intravenous infusion |
| Primary outcome measure | 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 study start date | 01/08/2006 |
| Completion date | 31/07/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Neonate |
| Sex | Not Specified |
| Target number of participants | 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
2300 RC
Netherlands
Sponsor information
Leiden University Medical Center (LUMC) (The Netherlands)
Hospital/treatment centre
Hospital/treatment centre
Department of Pediatrics Division of Neonatology, J6-S
P.O. Box 9600
Leiden
2300 RC
Netherlands
| Website | http://www.lumc.nl/ |
|---|---|
"ROR" |
https://ror.org/05xvt9f17 |
Funders
Funder type
Hospital/treatment centre
Sanquin Bloodbank Amsterdam (The Netherlands)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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.
