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NCT07194070Recruiting

A Study on Hemolytic Disease of the Fetus and Newborn (HDFN) Through Global Registry

Janssen Research & Development, LLC

Start Date

12/17/2025

Completion Date

9/30/2030

Summary

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 for hemolytic disease of the fetus and newborn (HDFN) and receiving standard of care (SoC). HDFN is a blood disease that occurs in babies before birth or just after birth when the blood types of the pregnant individual and babies are incompatible, thus resulting in fast breakdown of red blood cells (RBCs) of the fetus/baby.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: * Pregnant with an estimated gestational age (GA) (based on ultrasound dating) up to week 24 * History of a previous alloimmunized pregnancy that included at least one of the following: Fetal anemia diagnosed by middle cerebral artery (MCA) doppler ultrasound; Received greater than or equal to (\>=) 1 intrauterine transfusion (IUT) as a result of hemolytic disease of the fetus and newborn (HDFN); Fetal hydrops; Stillbirth or fetal demise with fetal or placental pathology indicative of HDFN; Neonatal exchange transfusion due to HDFN; Neonatal simple transfusion due to HDFN; Neonatal hyperbilirubinemia due to HDFN; Positive direct antiglobulin test (DAT) in neonate * Documented presence of maternal alloantibody based on local laboratory results during current pregnancy * Evidence of an antigen-positive fetus corresponding to the current maternal alloantibody: Fetal antigen status confirmed by cell-free fetal DNA (cffDNA); OR Fetal antigen status confirmed by amniocentesis; OR Paternal genotype confirmed * Pregnant participant or a legally acceptable representative has provided informed consent (per local regulations or ethics committee requirements) for the collection and use of their medical data and the medical data for their corresponding fetuses/neonates/infants/children Exclusion Criteria: * Participant actively participating in an interventional trial of an investigational agent * At risk for HDFN due to ABO being the sole alloimmunization antigen in the current pregnancy (that is, ABO plus another antigen is permissible)

Interventions

OTHER

Standard of Care

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Conditions

Hemolytic Disease of the Fetus and Newborn

Locations

Riley Children s Hospital

Indianapolis, Indiana 46202-5225

United States

University of Rochester Medical Center

Rochester, New York 14642

United States

University of Cincinnati

Cincinnati, Ohio 45219

United States

Oregon Health And Science University

Portland, Oregon 97239

United States

Baylor College of Medicine

Houston, Texas 77030

United States

The Royal Women's Hospital

Parkville, 3052

Australia

Mater Misericordiae Ltd

South Brisbane, 4101

Australia

Universitair Ziekenhuis Gent

Ghent, 9000

Belgium

Universitair Ziekenhuis Leuven

Leuven, 3000

Belgium

State University of Campinas Joao Bennini

Campinas, 13083-881

Brazil

Interdiszip Schwerpunkt fur Hamostaseologie

Giessen, 35392

Germany

Mangiagalli Clinic IRCCS Ca Granda Foundation Ospedale Maggiore Policlinico

Milan, 20122

Italy

Fondazione Policlinico Universitario A Gemelli IRCCS

Roma, 00137

Italy

Hosp Univ Vall D Hebron

Barcelona, 8035

Spain

Birmingham Women's Hospital

Birmingham, B15 2TG

United Kingdom