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

NCT07194070 | Recruiting

• 1 other identifier: NOPRODEBF0001
• Study Type: observational
• Target: 175
• Locations: 7 countries
• Sites: 13

Brief 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.

Conditions

Hemolytic Disease of the Fetus and Newborn

Outcome Measures

Primary Outcomes (1)

• Percentage of Pregnancies That did not Result in Fetal Loss, Intrauterine Transfusion (IUT), Hydrops Fetalis, or Neonatal Death During the Neonatal Period

  Percentage of pregnancies that did not result in fetal loss (due to any reason), IUT, hydrops fetalis, or neonatal death (due to any reason) during the neonatal period will be reported. Hydrops fetalis is defined as the presence of greater than or equal to (\>=) 2 abnormal fluid collections in the fetus or neonate, such as ascites, pleural effusions, pericardial effusion, and generalized skin edema (skin thickness greater than \[\>\] 5 millimeter \[mm\]). Post-menstrual age (PMA) is the time elapsed between the first day of the last menstrual period and birth (gestational age) plus the time elapsed after birth (chronological age).

  From conception through 4 weeks of age or 41 weeks PMA, whichever is later

Secondary Outcomes (4)

• Number of Participants With Hemolytic Disease of the Fetus and Newborn (HDFN) by Severity

  Through 4 weeks of age or 41 weeks PMA, whichever is later

• Time to First Occurrence of IUT or Hydrops Fetalis

  From conception to delivery date (up to maximum of 42 weeks)

• Modified Neonatal Morbidity and Mortality Index (mNMMI) in Live Newborn Neonates

  Through 38 weeks PMA or at discharge if earlier than 38 weeks PMA

• Number of IUTs Received During the Pregnancy

  From conception to delivery date (up to maximum of 42 weeks)

Study Arms (1)

Pregnant Participants at Risk for Hemolytic Disease of the Fetus and Newborn (HDFN)

Pregnant participants with a risk for HDFN in their current pregnancy will be enrolled. No treatment will be provided by the sponsor as a part of this study. Only data will be collected for participants for the duration of their pregnancy and for 2 years following birth for their corresponding neonate/infant/child. Data will be collected from eligible participants at medical centers that routinely diagnose and treat pregnant participants with HDFN. Additionally, participants will be asked to complete versions of clinical outcome assessments (Patient-reported outcomes \[PROs\]/Observer-reported outcomes \[ObsROs\]) at specific times throughout follow-up. Data collection will be considered complete for eligible participants if all available data have been recorded in the electronic case report form (eCRF).

Other: Standard of Care

Interventions

Standard of Care OTHER

No study treatment will be administered as part of this study. Participants will receive standard of care therapy as per local clinical practice.

Pregnant Participants at Risk for Hemolytic Disease of the Fetus and Newborn (HDFN)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will include pregnant participants with a risk for hemolytic disease of the fetus and newborn (HDFN) in their current pregnancy by virtue of having a previous alloimmunized pregnancy with a gestation that included fetal anemia, received intrauterine transfusion (IUT), fetal hydrops, stillbirth with fetal or placental pathology indicative of HDFN, neonatal exchange transfusion, neonatal hyperbilirubinemia due to HDFN, or positive direct antiglobulin test (DAT) in the neonate.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (13)

Riley Children s Hospital

Indianapolis, Indiana, 46202-5225, United States

RECRUITING

University of Cincinnati

Cincinnati, Ohio, 45219, United States

RECRUITING

Oregon Health And Science University

Portland, Oregon, 97239, United States

RECRUITING

Baylor College of Medicine

Houston, Texas, 77030, United States

RECRUITING

The Royal Women's Hospital

Parkville, 3052, Australia

RECRUITING

Mater Misericordiae Ltd

South Brisbane, 4101, Australia

RECRUITING

Universitair Ziekenhuis Gent

Ghent, 9000, Belgium

RECRUITING

Universitair Ziekenhuis Leuven

Leuven, 3000, Belgium

RECRUITING

Interdiszip Schwerpunkt fur Hamostaseologie

Giessen, 35392, Germany

RECRUITING

Mangiagalli Clinic IRCCS Ca Granda Foundation Ospedale Maggiore Policlinico

Milan, 20122, Italy

RECRUITING

Fondazione Policlinico Universitario A Gemelli IRCCS

Roma, 00137, Italy

RECRUITING

Hosp Univ Vall D Hebron

Barcelona, 8035, Spain

RECRUITING

Birmingham Women's Hospital

Birmingham, B15 2TG, United Kingdom

RECRUITING

Related Publications (1)

• Tjoa ML, Orillion A, Mankoski R, Imran N, Mao C, Krumme A, Van Hoorde S, Linares-Rivas Rico B, Komatsu Y. Study Design of the Global Prospective Hemolytic Disease of the Fetus and Newborn Registry (GERANIUM). Am J Perinatol. 2026 Mar 20. doi: 10.1055/a-2816-3361. Online ahead of print.

  PMID: 41862209 DERIVED

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Central Study Contacts

Study Contact

CONTACT

844-434-4210; Participate-In-This-Study1@its.jnj.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2025
• First Posted: September 26, 2025
• Study Start: December 17, 2025
• Primary Completion (Estimated): May 26, 2030
• Study Completion (Estimated): September 30, 2030
• Last Updated: June 5, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1); US (4); DE (1); BE (2); IT (2); ES (1); AU (2)