hemolytic disease of the newborn due to red blood cell alloimmunization
Conditions
Interventions
Product Name: recombinant human erythropoietin (rhEPO)
Pharmaceutical Form: Solution for injection
INN or Proposed INN: EPOETIN BETA
CAS Number: 122312-54-3
Concentration unit: U/ml unit(s)/millilitre
Sponsors
Leiden University Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: All (near)-term neonates (gestational age = 35 weeks) with HDN (due to Rhesus-D, -C, -c, -E, Kell or other red blood cell alloimmunization) treated with IUT and admitted to the Leiden University Medical Center (LUMC) between January 2011 and January 2014 are eligible for the study. The LUMC is the single national referral center in the Netherlands for pregnancies complicated by maternal red blood cell alloimmunization. Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Gestational age less than 35 weeks; neonates not formerly treated with intrauterine transfusion(s).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine if treatment with rhEPO reduces the need for top-up transfusions in neonates with HDN due to red cell alloimmunization treated with IUT.;Secondary Objective: To determine if treatment with rhEPO reduces the number of days of admission for top-up transfusions and reduces serum ferritin levels. To determine if the group treated with rhEPO has a better longterm neurodevelopmental outcome at 2 years of age (using the BSID-III test).;Primary end point(s): An absolute reduction of 50% of top-up transfusions. (The number of top-up transfusions required per infant and the percentage of infants requiring a top-up transfusion up to 3 months of life are the primary outcome measures.) | — |
Countries
Netherlands
Outcome results
None listed