Actively Recruiting
A Study on Hemolytic Disease of the Fetus and Newborn (HDFN) Through Global Registry
Led by Janssen Research & Development, LLC · Updated on 2026-05-08
175
Participants Needed
12
Research Sites
249 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study on Hemolytic Disease of the Fetus and Newborn (HDFN) Through Global Registry
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pregnant with an estimated gestational age up to week 24 based on ultrasound
- History of a previous alloimmunized pregnancy with at least one of these: fetal anemia diagnosed by middle cerebral artery doppler ultrasound; one or more intrauterine transfusions due to HDFN; fetal hydrops; stillbirth or fetal demise with HDFN pathology; neonatal exchange or simple transfusion due to HDFN; neonatal hyperbilirubinemia due to HDFN; positive direct antiglobulin test in neonate
- Documented presence of maternal alloantibody during current pregnancy based on local lab results
- Evidence of an antigen-positive fetus corresponding to current maternal alloantibody confirmed by cell-free fetal DNA, amniocentesis, or paternal genotype
- Provided informed consent for collection and use of medical data for self and fetus/neonate/infant/child as per local regulations
You will not qualify if you...
- Actively participating in an interventional trial of an investigational agent
- Risk for HDFN due only to ABO being the sole alloimmunization antigen in the current pregnancy (ABO plus another antigen is allowed)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 12 locations
1
Riley Children s Hospital
Indianapolis, Indiana, United States, 46202-5225
Actively Recruiting
2
University of Cincinnati
Cincinnati, Ohio, United States, 45219
Actively Recruiting
3
Oregon Health And Science University
Portland, Oregon, United States, 97239
Actively Recruiting
4
Baylor College of Medicine
Houston, Texas, United States, 77030
Actively Recruiting
5
The Royal Women's Hospital
Parkville, Australia, 3052
Actively Recruiting
6
Mater Misericordiae Ltd
South Brisbane, Australia, 4101
Actively Recruiting
7
Universitair Ziekenhuis Leuven
Leuven, Belgium, 3000
Actively Recruiting
8
Interdiszip Schwerpunkt fur Hamostaseologie
Giessen, Germany, 35392
Actively Recruiting
9
Mangiagalli Clinic IRCCS Ca Granda Foundation Ospedale Maggiore Policlinico
Milan, Italy, 20122
Actively Recruiting
10
Fondazione Policlinico Universitario A Gemelli IRCCS
Roma, Italy, 00137
Actively Recruiting
11
Hosp Univ Vall D Hebron
Barcelona, Spain, 8035
Actively Recruiting
12
Birmingham Women's Hospital
Birmingham, United Kingdom, B15 2TG
Actively Recruiting
Research Team
S
Study Contact
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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