Hemolytic Disease of the Fetus and NewbornGERANIUMNCT07194070
A Study on Hemolytic Disease of the Fetus and Newborn (HDFN) Through Global Registry
An observational study of Hemolytic Disease of the Fetus and Newborn, run by Janssen Research & Development, LLC at 15 sites in 8 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Hemolytic Disease of the Fetus and Newborn
- How many people
- 175 participants
- Where
- 15 sitesin 8 countries
- Study dates
- 17 Dec 2025to 30 Sep 2030
- How long will I take part?
- 2 Years
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
15 sites in 8 countries. Contact the study team or a site near you to ask about taking part.
15 sites in 8 countries
United States5 sites, 4 recruiting
- Recruiting
University of Cincinnati
Cincinnati, Ohio, 45219
- Recruiting
Baylor College of Medicine
Houston, Texas, 77030
- Suspended
Riley Children s Hospital
Indianapolis, Indiana, 46202-5225
- Recruiting
Oregon Health And Science University
Portland, Oregon, 97239
- Recruiting
University of Rochester Medical Center
Rochester, New York, 14642
Australia2 sites, 2 recruiting
- Recruiting
The Royal Women's Hospital
Parkville, 3052
- Recruiting
Mater Misericordiae Ltd
South Brisbane, 4101
Belgium2 sites, 2 recruiting
- Recruiting
Universitair Ziekenhuis Gent
Ghent, 9000
- Recruiting
Universitair Ziekenhuis Leuven
Leuven, 3000
Italy2 sites, 2 recruiting
- Recruiting
Mangiagalli Clinic IRCCS Ca Granda Foundation Ospedale Maggiore Policlinico
Milan, 20122
- Recruiting
Fondazione Policlinico Universitario A Gemelli IRCCS
Roma, 00137
Brazil1 site, 1 recruiting
- Recruiting
State University of Campinas Joao Bennini
Campinas, 13083-881
Germany1 site, 1 recruiting
- Recruiting
Interdiszip Schwerpunkt fur Hamostaseologie
Giessen, 35392
United Kingdom1 site, 1 recruiting
- Recruiting
Birmingham Women's Hospital
Birmingham, B15 2TG
About this study
Official title: Global Prospective Hemolytic Disease of the Fetus and Newborn 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.
- Being tested
- Standard of Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard of CareOther
No study treatment will be administered as part of this study. Participants will receive standard of care therapy as per local clinical practice.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Other: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
Number of participants in each HDFN severity index category will be reported. The severity of HDFN is defined as: 5 (fatal): fetal or neonatal death due to any reason; 4 (severe): hydrops fetalis (in fetus or newborn) or receiving IUT during pregnancy as a result of HDFN but not 5 (fatal); 3 (moderate): neonatal exchange transfusions received as a result of HDFN related hemolysis and jaundice but not 4 (severe) or 5 (fatal); 2 (mild): neonatal simple transfusions received due to HDFN after birth, with or without phototherapy, but not 3 (moderate), 4 (severe), or 5 (fatal); and 1 (minimal or none): not in 2 (mild), 3 (moderate), 4 (severe), or 5 (fatal) as described above. HDFN requiring phototherapy will be classified in this category.
Measured: Through 4 weeks of age or 41 weeks PMA, whichever is later
Time to First Occurrence of IUT or Hydrops Fetalis
Time to first occurrence of IUT or hydrops fetalis will be reported.
Measured: From conception to delivery date (up to maximum of 42 weeks)
Modified Neonatal Morbidity and Mortality Index (mNMMI) in Live Newborn Neonates
The mNMMI will be assessed with the following categories: fatal: neonatal death; major morbidity: any of intraventricular hemorrhage grade 3/4, seizures, hypoxic-ischemic encephalopathy, necrotizing enterocolitis stage 2/3, respiratory distress syndrome requiring mechanical ventilation, bronchopulmonary dysplasia requiring oxygen support, or persistent pulmonary hypertension; Minor morbidity: anemia requiring simple transfusion, hyperbilirubinemia requiring an exchange transfusion, hypotension requiring treatment, intraventricular hemorrhage grade 1/2, necrotizing enterocolitis stage 1, or respiratory distress syndrome not requiring mechanical ventilation; None: no major or minor morbidities described above. Hyperbilirubinemia requiring phototherapy will be classified in this category.
Measured: Through 38 weeks PMA or at discharge if earlier than 38 weeks PMA
Number of IUTs Received During the Pregnancy
Number of IUT's received during the pregnancy will be reported.
Measured: From conception to delivery date (up to maximum of 42 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2025
- Study start17 Dec 2025
- Primary completion26 May 2030 (estimated)
- Study completion30 Sep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hemolytic Disease of the Fetus and NewbornStudies of the same condition, open and under way.
- More trials run by Janssen Research & Development, LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 175 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Janssen Research & Development, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Research & Development, LLC Clinical Trial, Study director, Janssen Research & Development, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07194070
- Sponsor's protocol ID
- NOPRODEBF0001
- Other IDs
- NOPRODEBF0001
- Acronym
- GERANIUM
- Status last verified
- Sep 2026
- First submitted
- 11 Sep 2025
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 41862209