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NCT07194070 | RECRUITING | Hemolytic Disease of the Fetus and Newborn

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

Janssen Research & Development, LLC

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.

Condition or disease

Hemolytic Disease of the Fetus and Newborn

Intervention/treatment

Standard of Care

Study Type : OBSERVATIONAL
Estimated Enrollment : 175 participants
Official Title : Global Prospective Hemolytic Disease of the Fetus and Newborn Registry
Actual Study Start Date : 2025-11-28
Estimated Primary Completion Date : 2030-05-26
Estimated Study Completion Date : 2030-09-30

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers:
Criteria
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)
A Study on Hemolytic Disease of the Fetus and Newborn (HDFN) Through Global Registry

Location Details

NCT07194070

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Texas

Baylor College of Medicine

Houston, Texas, United States, 77030

RECRUITING

Italy,

University Polyclinic Foundation in Gemelli IRCCS

Roma, Italy, 00137