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New registry aims to understand anemia in newborns with blood disease

NCT ID NCT07194070

Knowledge-focused Sponsor: Janssen Research & Development, LLC Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 28, 2026 · Updated 4 times

Summary

This study is a global registry that will follow 175 pregnant people whose babies are at risk for hemolytic disease of the fetus and newborn (HDFN), a condition where the mother's and baby's blood types clash, causing rapid red blood cell breakdown. Researchers will track how often babies need transfusions, develop fluid buildup, or die, using standard care. The goal is to better understand the risks and outcomes of HDFN to improve future care.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 175 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2025

Expected to finish

Sep 2030

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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)

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Conditions

The condition(s) this trial relates to.

fetal erythroblastosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hemolytic disease of the fetus and newborn

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    15 sites in 8 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Baylor College of Medicine

    RECRUITING

    Houston, Texas, 77030, United States

  • Birmingham Women's Hospital

    RECRUITING

    Birmingham, B15 2TG, United Kingdom

  • Fondazione Policlinico Universitario A Gemelli IRCCS

    RECRUITING

    Roma, 00137, Italy

  • Hosp Univ Vall D Hebron

    RECRUITING

    Barcelona, 8035, Spain

  • Interdiszip Schwerpunkt fur Hamostaseologie

    RECRUITING

    Giessen, 35392, Germany

  • Mangiagalli Clinic IRCCS Ca Granda Foundation Ospedale Maggiore Policlinico

    RECRUITING

    Milan, 20122, Italy

  • Mater Misericordiae Ltd

    RECRUITING

    South Brisbane, 4101, Australia

  • Oregon Health And Science University

    RECRUITING

    Portland, Oregon, 97239, United States

  • Riley Children s Hospital

    SUSPENDED

    Indianapolis, Indiana, 46202-5225, United States

  • State University of Campinas Joao Bennini

    RECRUITING

    Campinas, 13083-881, Brazil

  • The Royal Women's Hospital

    RECRUITING

    Parkville, 3052, Australia

  • Universitair Ziekenhuis Gent

    RECRUITING

    Ghent, 9000, Belgium

  • Universitair Ziekenhuis Leuven

    RECRUITING

    Leuven, 3000, Belgium

  • University of Cincinnati

    RECRUITING

    Cincinnati, Ohio, 45219, United States

  • University of Rochester Medical Center

    RECRUITING

    Rochester, New York, 14642, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.