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 17 sites in 9 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
- 17 sitesin 9 countries
- Study dates
- 17 Dec 2025to 30 Sep 2030
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
17 sites in 9 countries. Contact the study team or a site near you to ask about taking part.
17 sites in 9 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
Brazil2 sites, 2 recruiting
- Recruiting
State University of Campinas Joao Bennini
Campinas, 13083-881
- Recruiting
Hospital Das Clinicas Da Faculdade De Medicina Da Universidade De Sao Paulo
São Paulo, 01246-903
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
Canada1 site, 1 recruiting
- Recruiting
BC Women's Hospital University of British Columbia
Vancouver, British Columbia, V6H 3N1
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
- Nov 2026
- First submitted
- 11 Sep 2025
- Last updated
- 3 Nov 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
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Global Prospective Hemolytic Disease of the Fetus and Newborn Registry
- ClinicalTrials.gov ID
- NCT07194070
- Acronym / sponsor ID
- GERANIUM / NOPRODEBF0001
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 175 participants (estimated)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- 17 Dec 2025 (actual)
- Primary completion
- 26 May 2030 (estimated)
- Study completion
- 30 Sep 2030 (estimated)
- First posted
- 26 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pregnant Participants at Risk for Hemolytic Disease of the Fetus and Newborn (HDFN) | – | Other: Standard of CarePregnant 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard of CareNo study treatment will be administered as part of this study. Participants will receive standard of care therapy as per local clinical practice. | Other | Pregnant Participants at Risk for Hemolytic Disease of the Fetus and Newborn (HDFN) |
Primary outcome
Percentage of Pregnancies That did not Result in Fetal Loss, Intrauterine Transfusion (IUT), Hydrops Fetalis, or Neonatal Death During the Neonatal Period
Time frame: From conception through 4 weeks of age or 41 weeks PMA, whichever is later
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).
4 secondary outcomes
Number of Participants With Hemolytic Disease of the Fetus and Newborn (HDFN) by Severity
Time frame: Through 4 weeks of age or 41 weeks PMA, whichever is later
Time to First Occurrence of IUT or Hydrops Fetalis
Time frame: From conception to delivery date (up to maximum of 42 weeks)
Modified Neonatal Morbidity and Mortality Index (mNMMI) in Live Newborn Neonates
Time frame: Through 38 weeks PMA or at discharge if earlier than 38 weeks PMA
Number of IUTs Received During the Pregnancy
Time frame: From conception to delivery date (up to maximum of 42 weeks)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Derived from this study: PubMed 41862209Tjoa 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.
- Individual participant dataSharing planned: No
Related trials for Hemolytic Disease of the Fetus and Newborn
RecruitingPhase 3
A Study of Nipocalimab in Pregnancies at Risk for Severe Hemolytic Disease of the Fetus and Newborn (HDFN)
Hemolytic Disease of the Fetus and Newborn
RecruitingPhase 2
Neonatal Outcomes on Direct Fetal Intravenous Immunoglobulin During Intrauterine Transfusion for Rhesus Isoimmunization
Hemolytic Disease of the Newborn, Fetal Anemia
Not yet recruiting
Heterologous Cord Blood-Derived Red Blood Cell for Transfusion in Extremely Preterm Infants
Extremely Premature Infant, Anemia Neonatal
Not yet recruitingObservational study
Application of Quantitative Hemorrhage Detection in Fetomaternal Hemorrhage Syndrome for the Diagnosis of Hemolytic Disease of the Newborn
Hemolytic Disease of the Newborn
RecruitingPhase 1
Study of Panobinostat (LBH589) in Patients With Sickle Cell Disease
Sickle Cell Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Janssen Research & Development, LLC Clinical Trial study director
Janssen Research & Development, LLC
17 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hemolytic Disease of the Fetus and Newborn, run by Janssen Research & Development, LLC at 17 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in United States, Australia, Belgium, Brazil, Italy and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Study Contact (844-434-4210, Participate-In-This-Study1@its.jnj.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Pregnancies That did not Result in Fetal Loss, Intrauterine Transfusion (IUT), Hydrops Fetalis, or Neonatal Death During the Neonatal Period (time frame: From conception through 4 weeks of age or 41 weeks PMA, whichever is later). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07194070, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.