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NCT Number: NCT07194070

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

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Key information

Conditions

Hemolytic Disease of the Fetus and Newborn

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

The Royal Women's Hospital, Parkville, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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)

Treatment and study plan

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.

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

    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).

Secondary outcomes

  1. 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

    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.

  2. Time to First Occurrence of IUT or Hydrops Fetalis

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

    Time to first occurrence of IUT or hydrops fetalis will be reported.

  3. 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

    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.

  4. Number of IUTs Received During the Pregnancy

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

    Number of IUT's received during the pregnancy will be reported.

Study contacts

Contact information is provided by the study sponsor or research team.

Study Contact

CONTACT

[email protected]

844-434-4210

Sponsors and collaborators

Lead sponsor

Janssen Research & Development, LLC

Industry

Registry information

Official study title

Global Prospective Hemolytic Disease of the Fetus and Newborn Registry

Acronym: GERANIUM

Important dates

Study start
2025
Primary completion
2030
Study completion
2030
First posted
Sep 26, 2025
Registry last updated
Jul 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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