Staying informed about ongoing research programs and clinical trials accepting new participants can be challenging. This page provides up-to-date information on current clinical trials for women with alloimmunization and children with Hemolytic Disease of the Fetus and Newborn (HDFN). If you have a research program or trial to add to this list, or if you are interested in collaborating or participating in research, please reach out to us here.
A Study of Nipocalimab in Pregnancies at Risk for Severe Hemolytic Disease of the Fetus and Newborn (HDFN) (AZALEA)
Brief Summary:
Pregnant female participants must be ≥18 years of age with an estimated gestational age of 8 to 13 weeks at enrollment; a previous pregnancy with a gestation that included at least one condition [severe fetal anemia, fetal hydrops (ascites), or stillbirth with fetal or placental pathology indicative of Hemolytic Disease of the Fetus and Newborn] at ≤24 weeks gestation; not currently pregnant with multiples (twins or more), up to date on required immunizations; and no other clinically relevant abnormalities currently or in their history that the Investigator would deem them ineligible to participate.
https://clinicaltrials.gov/study/NCT05912517
Epo-4-Rhesus
Brief Summary:
Up to 80% of infants with hemolytic disease due to maternal alloimmunization, treated with IUT, require at least one top-up transfusion for late anemia during the first 3 months of life. Erythropoietin deficiency is also considered as a possible contributing factor to late anemia and therefore we will assess the role of EPO (darbepoetin alfa) in the treatment of these infants.
Links:
https://clinicaltrials.gov/study/NCT03104426
Establish a Non-invasive Prenatal Genotyping and Extraction Technology to Diagnose and Treat the HDN
Brief Summary:
To establish a genotyping and extraction technology of non invasive prenatal diagnosis for fetal blood group genotype from cell-free fetal DNA in peripheral blood of pregnant women.
To achieve prenatal accurate identification of fetal blood group genotypes，and provide credible theoretical evidence for the prenatal diagnosis and treatment of hemolytic disease of newborn (HDN).
https://clinicaltrials.gov/study/NCT02969174
Safe Threshold to Discontinue Phototherapy in Hemolytic Disease of Newborn
Brief Summary:
We hypothesized that adopting a lower rather than a higher threshold for phototherapy discontinuation will be associated with reduced rates of rebound hyperbilirubinemia in term and late preterm neonates with hemolytic disease of newborn.
Objectives: The investigators aimed to compare the safety of implementing low-threshold, compared to high- threshold, of TSB for phototherapy interruption in term and late preterm neonates with hemolytic disease of newborn.
https://clinicaltrials.gov/study/NCT04218318
Transfusion in Sickle Cell Disease: Risk Factors for Alloimmunization
Brief Summary:
Sickle cell patients have a high prevalence of alloimmunization. This high rate of alloimmunization can be partially explained by the existence of an antigenic difference between the predominantly Caucasian donor population and the sickle cell patients of African origin. Genetic and environmental risk factors have also been described.
The main risk factors that have been shown in retrospective or cross-sectional studies are some HLA alleles, the age of the patient, the number of leukocyte-depleted erythrocyte concentrates (CED) transfused, the number of transfusion episodes, the age of the CEDs, the existence of an inflammatory event at the time of transfusion and the presence of anti-erythrocyte autoantibodies. There is also evidence of an impaired TH response but the underlying immunological mechanism is not fully understood.
The aim of this study is to study the prevalence and the risk factors for anti-erythrocyte alloimmunization and to try to understand the immunological mechanisms.