Recombinant Human Erythropoietin (rhEPO) Hemolytic Disease of the Newborn Red blood cell alloimmunization Intrauterine red cell transfusion
Conditions
Interventions
After informed consent, stratification into two groups (with and without intrauterine blood transfusion) will be accomplished. After stratification, included neonates will be randomized at birth to tr
13 g/dL after at least 4 weeks of treatment with rhEPO. Monthly measurements of liver enzymes (aspartate aminotransferase (ASAT), alanine aminotransferase (ALAT), gamma-glutamyl transferase (gammaGT)
Sponsors
Leiden University Medical Center (LUMC)
Eligibility
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 or without IUT and admitted to the Leiden University Medical Center (LUMC) 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.
Exclusion criteria
Exclusion criteria: Preterm neonates (gestational age < 35 weeks).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Number of top-up transfusions required per infant; 2. The percentage of infants requiring a top-up transfusion up to 3 months of life. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Number of days of admission for top-up transfusions; 2. Reduction in ferritin levels; 3. Long term neurodevelopmental outcome at 2 years of age using the BSID-III test. | — |
Contacts
Public ContactE. Lopriore
Leiden University Medical Center (LUMC), Department of Pediatrics Division of Neonatology, J6-S P.O. Box 9600
Outcome results
None listed