Leiden's IVIg trial in Rhesus disease of the Neonate

Leiden's IVIg trial in Rhesus disease of the Neonate - LIVIN' study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON29923

Enrollment

Registered

2006-06-01

Start date

2006-05-01

Completion date

Unknown

Last updated

2024-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rhesus disease

Interventions

Prior to randomization, stratification into two groups (with and without intrauterine blood transfusion) will occur. At birth, patients are then randomized to the IVIg treatment group (group A) or p

Eligibility

Age

2 Years to 11 Years

Inclusion criteria

Inclusion criteria: 7.1 Inclusion criteria: Neonates of 35 or more weeks of gestation with Rh-D hemolytic disease admitted to the neonatal nursery of the Leiden University Medical Center (LUMC). Rh-D hemolytic disease was defined as (1) Antibody Dependent Cellular Cytotoxicity-test (ADCC) > 50% and (2) positive direct Coombs test in a Rh-D positive fetus/neonate with a Rh-D negative mother and a Rh-D positive father. Previous intra-uterine transfusions and the presence of additional antibodies besides anti-D are not reasons for exclusion.

Exclusion criteria

Exclusion criteria: 7.2 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. (3) Neonates with Rh-D hemolytic disease presenting > 24 hours after birth.

Design outcomes

Primary

Measure	Time frame
13.1 Primary outcomes a. Use of ET (%; proportion of children receiving one or more ET) b. Number of ET performed per infant	—

Secondary

Measure	Time frame
13.2 Secondary outcomes c. Duration of phototherapy (number of days) d. Maximum serum bilirubin (mmol/l) e. Change in bilirubin in first 24 hours (%) f. Change in bilirubin in first 48 hours (%) g. 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) h. 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) i. Duration of hospital stay (number of days)	—

Measure

Time frame

13.2 Secondary outcomes c. Duration of phototherapy (number of days) d. Maximum serum bilirubin (mmol/l) e. Change in bilirubin in first 24 hours (%) f. Change in bilirubin in first 48 hours (%) g. 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) h. 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) i. Duration of hospital stay (number of days)

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)