Clinical trials: Erythroblastosis, Fetal
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)
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
Alpha Thalassemia Major, Hemoglobinopathy; With Thalassemia
In Utero Hematopoietic Stem Cell Transplantation for Alpha-thalassemia Major (ATM)
The investigators aims to evaluate the safety of in utero hematopoietic stem cell transplantation in fetuses with alpha-thalassemia major performed at the time of in utero transfusion of red blood cells.
- Conditions
- Alpha Thalassemia Major, Hemoglobinopathy; With Thalassemia, Hemoglobinopathies, Fetal Anemia
- Trial name
- NCT02986698
- Testing
- in utero hematopoietic stem cell transplantation
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- University of California, San Francisco
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
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
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
Bilirubin-induced Neurologic Dysfunction, Hyperbilirubinemia
Bilirubin Binding Capacity to Assess Bilirubin Load in Preterm Infants
Most preterm newborns are managed by phototherapy to reverse hyperbilirubinemia with the intent to prevent bilirubin neurotoxicity.
- Conditions
- Bilirubin-induced Neurologic Dysfunction, Hyperbilirubinemia, Kernicterus, Infant, Premature
- Trial name
- NCT02691156
- Testing
- Bilirubin Binding Capacity, End-tidal Carbon Monoxide, Carboxyhemoglobin
- Where
- United States
- Volunteers
- 143 people, healthy volunteers welcome
- Sponsor
- Stanford University
Hydrops Fetalis, Birth Defect
Hydrops: Diagnosing & Redefining Outcomes With Precision Study
This is a national, prospective study designed to investigate the genetic etiologies of non-immune hydrops fetalis (NIHF) and other birth defects.
- Conditions
- Hydrops Fetalis, Birth Defect, Fetal Anomaly
- Trial name
- HyDROPS (NCT03412760)
- Testing
- Exome sequencing
- Where
- United States
- Volunteers
- 500 people
- Sponsor
- University of California, San Francisco
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
Haemoglobin Barts Hydrops
In-utero Hematopoietic Stem Cell Transplantation for the Treatment of Fetuses With Bart's Hydrops Fetalis Syndrome
This is a prospective observational pilot study on pregnant women who are diagnosed to have Bart's hydrops fetalis syndrome (BHFS) affected fetuses and opt for continuation of pregnancy will be invited to consider undergoing…
- Trial name
- NCT05797272
- Testing
- in-utero HSCT
- Where
- Hong Kong
- Volunteers
- 10 people
- Sponsor
- Chinese University of Hong Kong
Kernicterus
Does Maternal Instruction Prevent Kernicterus in Nigeria?
This study examines (a) whether introduction of public, health provider, and maternal education about risks of jaundice will decrease the occurrence of ABE compared with baseline prevalence (before-after design) or (b) whether…
- Trial name
- NCT02713464
- Testing
- maternal education
- Volunteers
- 1,765 people
- Sponsor
- Bilimetrix s.r.l.
Hyperbilirubinemia, Erythroblastosis, Fetal
Efficacy of High-dose Intravenous Immunoglobulin Therapy for Hyperbilirubinemia Due Rh Hemolytic Disease
The use of intravenous immunoglobulin G (IVIG) therapy has been reported in hyperbilirubinemia of Rh hemolytic disease but we don't have enough evidences for it.
- Trial name
- NCT00288600
- Testing
- Intravenous Immunoglobulin, Normal saline solution
- Where
- Brazil
- Volunteers
- 92 people
- Sponsor
- Oswaldo Cruz Foundation
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
Atrial Flutter, Tachycardia, Supraventricular
Prospective Observational Cohort Study of Fetal Atrial Flutter & Supraventricular Tachycardia
The FAST Trial Registry is a prospective observational cohort study of fetuses with a new diagnosis of atrial flutter (AF) or supraventricular tachycardia (SVT) that is severe enough to consider prenatal treatment (see…
- Conditions
- Atrial Flutter, Tachycardia, Supraventricular, Tachycardia, Atrial Ectopic, Tachycardia, Reciprocating
- Trial name
- FAST Registry (NCT03376438)
- Testing
- Prospective observational cohorts
- Where
- 41 sites in United States, Australia and 12 more
- Volunteers
- 330 people
- Sponsor
- Edgar Jaeggi
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
High Risk Pregnancy, Congenital Heart Disease
Fetal Electrophysiologic Abnormalities in High-Risk Pregnancies Associated With Fetal Demise
Each year world-wide, 2.5 million fetuses die unexpectedly in the last half of pregnancy, 25,000 in the United States, making fetal demise ten-times more common than Sudden Infant Death Syndrome.
- Conditions
- High Risk Pregnancy, Congenital Heart Disease, Fetal Hydrops, Twin Monochorionic Monoamniotic Placenta
- Trial name
- NCT03775954
- Testing
- Fetal Magnetocardiogram and Neonatal Electrocardiogram, Substudy only: Maternal/Infant Pharmacogenomic assessment postnatally
- Where
- 2 sites in United States
- Volunteers
- 30 people
- Sponsor
- Medical College of Wisconsin
Fetal Hydrops
Precision Medical Research of Non-immune Fetal Hydrops (NIFH)-From Prenatal Diagnosis to Intrauterine Treatment
Based on multi-center clinical research resources, a large-scale prospective cohort study will be conduted to make a more accurate diagnosis and intervention plan of Non-immune fetal hydrops (NIFH), and then establish NIFH…
- Trial name
- NCT02956564
- Testing
- intrauterine intervention
- Volunteers
- 144 people
- Sponsor
- Shanghai First Maternity and Infant Hospital
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
Neonatal Jaundice
Reliability of Transcutaneous Bilirubin Measurement According to the Skin Colour of Newborns
Neonatal jaundice is a physiological process characterized by a yellow coloration of the skin and mucous membranes linked to an increase in a pigment: bilirubin.
- Trial name
- BILICOLOR (NCT07315126)
- Testing
- Skin color assessment
- Where
- France
- Volunteers
- 510 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Hypoxic-Ischemic Encephalopathy, Periventricular Leukomalacia
Evaluation of Long-term Neurodevelopment in Neonatal Encephalopathy by Infant Treadmill
There is no international application of infant running stimulation system to evaluate the brain injury in children with various stages of nerve and motor development in a large sample of studies.
- Conditions
- Hypoxic-Ischemic Encephalopathy, Periventricular Leukomalacia, Intraventricular Hemorrhage, Bilirubin Encephalopathy
- Trial name
- NCT03527498
- Testing
- Baby treadmill, Physical rehabilitation training
- Where
- China
- Sponsor
- Children's Hospital of Fudan University