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

Официальное название

Global Prospective Hemolytic Disease of the Fetus and Newborn Registry

Обзор

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.

Вмешательства

• Другое Standard of Care
  No study treatment will be administered as part of this study. Participants will receive standard of care therapy as per local clinical practice.

Первичные конечные точки

• Percentage of Pregnancies That did not Result in Fetal Loss, Intrauterine Transfusion (IUT), Hydrops Fetalis, or Neonatal Death During the Neonatal Period [Срок оценки: From conception through 4 weeks of age or 41 weeks PMA, whichever is later]

Вторичные конечные точки (4)

• Number of Participants With Hemolytic Disease of the Fetus and Newborn (HDFN) by Severity [Срок оценки: Through 4 weeks of age or 41 weeks PMA, whichever is later]
• Time to First Occurrence of IUT or Hydrops Fetalis [Срок оценки: From conception to delivery date (up to maximum of 42 weeks)]
• Modified Neonatal Morbidity and Mortality Index (mNMMI) in Live Newborn Neonates [Срок оценки: Through 38 weeks PMA or at discharge if earlier than 38 weeks PMA]
• Number of IUTs Received During the Pregnancy [Срок оценки: From conception to delivery date (up to maximum of 42 weeks)]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

США · 5 центров

• Riley Children s Hospital — Indianapolis
• University of Rochester Medical Center — Rochester
• University of Cincinnati — Cincinnati
• Oregon Health And Science University — Portland
• Baylor College of Medicine — Houston

Австралия · 2 центра

• The Royal Women's Hospital — Parkville
• Mater Misericordiae Ltd — South Brisbane

Бельгия · 2 центра

• Universitair Ziekenhuis Gent — Ghent
• Universitair Ziekenhuis Leuven — Leuven

Италия · 2 центра

• Mangiagalli Clinic IRCCS Ca Granda Foundation Ospedale Maggiore Policlinico — Milan
• Fondazione Policlinico Universitario A Gemelli IRCCS — Roma

Бразилия · 1 центр

• State University of Campinas Joao Bennini — Campinas

Германия · 1 центр

• Interdiszip Schwerpunkt fur Hamostaseologie — Giessen

Испания · 1 центр

• Hosp Univ Vall D Hebron — Barcelona

Великобритания · 1 центр

• Birmingham Women's Hospital — Birmingham

Публикации

• 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. PMID 41862209

Идентификаторы

NCT: NCT07194070 · NOPRODEBF0001 · NOPRODEBF0001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗