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| ID | Type | Description | Link |
|---|---|---|---|
| NOPRODEBF0001 | Other Identifier | Janssen Research & Development, LLC |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Study Contact | Contact | 844-434-4210 | Participate-In-This-Study1@its.jnj.com |
| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Riley Children s Hospital | Recruiting | Indianapolis | Indiana | 46202-5225 | United States | |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41862209 | Derived | 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. |
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| 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. | 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. | 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. | From conception to delivery date (up to maximum of 42 weeks) |
| University of Cincinnati |
| Recruiting |
| Cincinnati |
| Ohio |
| 45219 |
| United States |
| Oregon Health And Science University | Recruiting | Portland | Oregon | 97239 | United States |
| Baylor College of Medicine | Recruiting | Houston | Texas | 77030 | United States |
| The Royal Women's Hospital | Recruiting | Parkville | 3052 | Australia |
| Mater Misericordiae Ltd | Recruiting | South Brisbane | 4101 | Australia |
| Universitair Ziekenhuis Gent | Recruiting | Ghent | 9000 | Belgium |
| Universitair Ziekenhuis Leuven | Recruiting | Leuven | 3000 | Belgium |
| State University of Campinas Joao Bennini | Recruiting | Campinas | 13083-881 | Brazil |
| Interdiszip Schwerpunkt fur Hamostaseologie | Recruiting | Giessen | 35392 | Germany |
| Mangiagalli Clinic IRCCS Ca Granda Foundation Ospedale Maggiore Policlinico | Recruiting | Milan | 20122 | Italy |
| Fondazione Policlinico Universitario A Gemelli IRCCS | Recruiting | Roma | 00137 | Italy |
| Hosp Univ Vall D Hebron | Recruiting | Barcelona | 8035 | Spain |
| Birmingham Women's Hospital | Recruiting | Birmingham | B15 2TG | United Kingdom |
| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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