Efficacy of Darbepoetin alpha in reducing the need for top-up transfusions in neonates born at more than or equal to 34 weeks of gestation with Rh isoimmunisation treated with intrauterine transfusion: a Randomised control trial

This open-label randomized controlled trial aims to evaluate the efficacy of darbepoetin alpha in reducing top-up packed red blood cell (PRBC) transfusion requirements in neonates born at more than or equal to 34 weeks of gestation with Rh isoimmunization who have received one or more intrauterine transfusions. Eligible neonates will be screened on Day 7 (Day 6-Day 8) of life and, after consent, will be randomized to receive either darbepoetin alpha (10 mcg/kg/week subcutaneously) for 4 weeks (if hemoglobin at the end of 4 weeks is more than 13 g/dL) or until 8 weeks (if hemoglobin at the end of 4 weeks is less than 13 g/dL) in addition to standard care (intervention group) or standard care alone (phototherapy, exchange transfusion, folic acid) (control group). The primary objective is to assess reduction in packed red blood cell transfusions between Day 7 and 3 months of age. Secondary objectives include comparison of hemoglobin levels, reticulocyte counts, serum ferritin, peripheral smear findings (for evidence of hemolysis), and blood pressure recordings. Baseline investigations include serum erythropoietin, reticulocyte count, and hemoglobin. The study will enroll 56 neonates and be conducted at AIIMS New Delhi’s NICU, postnatal ward, and high-risk clinic. This trial addresses a critical evidence gap by focusing specifically on Rh isoimmunized neonates, a population frequently requiring multiple transfusions due to late-onset hypoproliferative anemia, particularly in resource-limited settings. Findings will provide valuable insights into erythropoiesis-stimulating agent (ESA) use in hemolytic disease of the fetus and newborn due to Rh incompatibility.