Clinical trials: Hemolytic Disease of the Newborn
Hemolytic Disease of the Newborn, Fetal Anemia
Neonatal Outcomes on Direct Fetal Intravenous Immunoglobulin During Intrauterine Transfusion for Rhesus Isoimmunization
The goal of this clinical trial is to learn if giving intravenous immunoglobulin directly to the fetus during intrauterine transfusion can improve newborn outcomes in pregnancies affected by rhesus isoimmunization.
- Conditions
- Hemolytic Disease of the Newborn, Fetal Anemia, Rhesus Isoimmunization, Erythroblastosis Fetalis Due to RH Antibodies
- Trial name
- NCT07885592
- Testing
- Intrauterine Transfusion, Intravenous immunoglobulin (IVIG)
- Where
- India
- Volunteers
- 30 people
- Sponsor
- Post Graduate Institute of Medical Education and Research, Chandigarh
Hemolytic Disease of the Fetus and Newborn
A Study of Nipocalimab in Pregnancies at Risk for Severe Hemolytic Disease of the Fetus and Newborn (HDFN)
The purpose of this study is to assess the effectiveness of nipocalimab when compared to placebo in decreasing the risk of fetal anemia (a condition in which a baby's red blood cell volume falls below normal levels while the baby…
- Trial name
- AZALEA (NCT05912517)
- Testing
- Nipocalimab
- Where
- 65 sites in United States, Argentina and 15 more
- Volunteers
- 120 people
- Sponsor
- Janssen Research & Development, LLC
Hemolytic Disease of the Fetus and Newborn
A Study on Hemolytic Disease of the Fetus and Newborn (HDFN) Through Global Registry
The purpose of this non-interventional study is to prospectively evaluate the risk of anemia (decreased red blood cells) in fetuses (baby before birth) and neonates (baby just after birth) of pregnant participants who are at risk…
- Trial name
- GERANIUM (NCT07194070)
- Testing
- Standard of Care
- Where
- 15 sites in United States, Australia and 6 more
- Volunteers
- 175 people
- Sponsor
- Janssen Research & Development, LLC
Hemolytic Disease of the Fetus and Newborn
A Study to Evaluate the Safety, Efficacy, Pharmacokinetics and Pharmacodynamics of M281 Administered to Pregnant Women at High Risk for Early Onset Severe Hemolytic Disease of the Fetus and Newborn (HDFN)
The purpose of this study is to evaluate the safety in mother and neonate/infant of M281 administered to pregnant women who are at high risk for Early Onset Severe Hemolytic Disease of the Fetus and Newborn (EOS-HDFN).
- Trial name
- NCT03842189
- Testing
- M281
- Where
- 19 sites in United States, Australia and 7 more
- Volunteers
- 25 people
- Sponsor
- Janssen Research & Development, LLC
Hemolytic Disease of the Newborn
Application of Quantitative Hemorrhage Detection in Fetomaternal Hemorrhage Syndrome for the Diagnosis of Hemolytic Disease of the Newborn
This study adopted a single-center, prospective, observational study design. A consecutive cohort of pregnant and postpartum women who met the inclusion criteria was recruited from Shanghai First People's Hospital between January…
- Trial name
- NCT07371520
- Where
- China
- Volunteers
- 100 people
- Sponsor
- Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Hemolytic Disease of Newborn, Anemia of Neonates
Risk Factors and Clinical Outcomes of Neonatal Anemia in NICU
Risk Factors, and Clinical Outcomes of Neonatal Anemia in the NICU of a Tertiary Care Hospital
- Conditions
- Hemolytic Disease of Newborn, Anemia of Neonates, Sepsis
- Trial name
- NCT07188298
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Assiut University
Early Onset Severe Hemolytic Disease of the Fetus and Newborn (EOS-HDFN), Erythroblastosis, Fetal
A Study to Characterize the Clinical Course of Pregnant Women and Children at High Risk for Early Onset Severe Hemolytic Disease of the Fetus and Newborn
The primary purpose of the study is to characterize the current standard of care, clinical course, and outcomes of pregnant women and their offspring at high risk for early onset severe hemolytic disease of the fetus and newborn…
- Trial name
- NCT03755128
- Testing
- No intervention
- Where
- 18 sites in United States, Australia and 7 more
- Volunteers
- 17 people
- Sponsor
- Janssen Research & Development, LLC
s100b, Hypoxia-Ischemia, Brain
Cord Blood S100B Protein Levels in Neonates Following Intrauterine Transfusions for HDFN-Associated Fetal Anemia
levated levels of S100B protein are a well-established marker of central nervous system (CNS) damage. Fetal anemia resulting from hemolytic disease of the fetus and newborn (HDFN) often necessitates intrauterine transfusions…
- Conditions
- s100b, Hypoxia-Ischemia, Brain, Hemolytic Disease of the Fetus and Newborn, Fetal Anemia
- Trial name
- NCT06984445
- Testing
- Cord blood S100B protein level prior to IUT, Umbilical cord blood gas analysis prior to IUT, Fetal blood count evaluation prior to IUT
- Where
- Poland
- Volunteers
- 180 people
- Sponsor
- Institute of Mother and Child, Warsaw, Poland
ABO Hemolytic Disease of Newborn
Clinical Value of ETCOc in the Diagnosis and Treatment of ABO-HDN
A prospective observational cohort study was designed. 1. Comparing of the clinical indicators between the hemolytic group and the non-hemolytic group,such as End-tidal carbon monoxide corrected for ambient CO(ETCOc),direct…
- Trial name
- NCT05842109
- Where
- China
- Volunteers
- 112 people
- Sponsor
- Women's Hospital School Of Medicine Zhejiang University
Hemolytic Disease of Newborn, Neonatal Hyperbilirubinemia
Safe Threshold to Discontinue Phototherapy in Hemolytic Disease of Newborn
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…
- Trial name
- NCT04218318
- Testing
- phototherapy
- Where
- Saudi Arabia
- Volunteers
- 84 people, healthy volunteers welcome
- Sponsor
- Ministry of Health, Saudi Arabia
Bone Marrow Failure Syndrome, Thalassemia
Conditioning Regimen for Allogeneic Hematopoietic Stem-Cell Transplantation
In this study, the investigators test 2 dose levels of thiotepa (5 mg/kg and 10 mg/kg) added to the backbone of targeted reduced dose IV busulfan, fludarabine and rabbit anti-thymocyte globulin (rATG) to determine the minimum…
- Conditions
- Bone Marrow Failure Syndrome, Thalassemia, Sickle Cell Disease, Diamond Blackfan Anemia
- Trial name
- NCT03513328
- Testing
- Thiotepa--single daily dose, Thiotepa--escalated dose
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- University of Florida
HDN - Hemolytic Disease of the Newborn
Neonatal Cord Blood Screening for HDN
To evaluate the diagnostic efficiency of antibodies screening in cord blood for detection of HDN. To help finding the antigen negative blood in a timely manner and reduce the morbidities and mortalities of HDN
- Trial name
- NCT05617612
- Volunteers
- 400 people
- Sponsor
- Assiut University
ABO Incompatibility, Hemolytic Disease of Newborn
Measurement of Carboxyhemoglobin by Gas Chromatography as an Index of Hemolysis
The purpose of this research study is to more accurately measure the amount of true red blood cell breakdown (hemolysis) in newborn babies with potentially problematic blood type mismatch with their mothers (ABO incompatibility)…
- Conditions
- ABO Incompatibility, Hemolytic Disease of Newborn, Neonatal Jaundice, Neonatal Hyperbilirubinemia
- Trial name
- NCT00917007
- Where
- 2 sites in United States
- Sponsor
- State University of New York - Upstate Medical University
Glucosephosphate Dehydrogenase Deficiency, Hyperbilirubinemia
Phase II Randomized Study of Tin Mesoporphyrin for Neonatal Hyperbilirubinemia
OBJECTIVES: I. Compare the efficacy of preventive vs. therapeutic tin mesoporphyrin in direct Coombs' test-positive ABO hemolytic disease of the newborn and glucose-6-phosphate dehydrogenase deficiency in infants living in…
- Conditions
- Glucosephosphate Dehydrogenase Deficiency, Hyperbilirubinemia, Hemolytic Disease of Newborn
- Trial name
- NCT00004381
- Testing
- tin mesoporphyrin
- Where
- 2 sites in United States
- Sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)