A Study on Hemolytic Disease of the Fetus and Newborn (HDFN) Through Global Registry
Global Prospective Hemolytic Disease of the Fetus and Newborn Registry
- Hemolytic Disease of the Fetus and Newborn
At a glance
- Phase
- Phase not stated
- Study type
- Observational
- Sponsor
- Janssen Research & Development, LLC
- Enrolment target
- 175
- Started
- 17 December 2025
- Main results due
- 26 May 2030
- Study sites
- 15
- Registry updated
- 25 September 2026
Can you take part?
- Aged 18 years and over.
- Women only.
- You need the condition being studied — healthy volunteers are not accepted.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full eligibility criteria
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)
What this study is about
In the sponsor’s own words, from the 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 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.
Study sites(15)
Riley Children s Hospital
Indianapolis, Indiana, United States
Suspended
University of Rochester Medical Center
Rochester, New York, United States
Recruiting
University of Cincinnati
Cincinnati, Ohio, United States
Recruiting
Oregon Health And Science University
Portland, Oregon, United States
Recruiting
Baylor College of Medicine
Houston, Texas, United States
Recruiting
The Royal Women's Hospital
Parkville, Australia
Recruiting
Mater Misericordiae Ltd
South Brisbane, Australia
Recruiting
Universitair Ziekenhuis Gent
Ghent, Belgium
Recruiting
Universitair Ziekenhuis Leuven
Leuven, Belgium
Recruiting
State University of Campinas Joao Bennini
Campinas, Brazil
Recruiting
Interdiszip Schwerpunkt fur Hamostaseologie
Giessen, Germany
Recruiting
Mangiagalli Clinic IRCCS Ca Granda Foundation Ospedale Maggiore Policlinico
Milan, Italy
Recruiting
Fondazione Policlinico Universitario A Gemelli IRCCS
Roma, Italy
Recruiting
Hosp Univ Vall D Hebron
Barcelona, Spain
Recruiting
Birmingham Women's Hospital
Birmingham, United Kingdom
Recruiting
Showing 15 of 15 sites. 14 of the 15 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT07194070. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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