RecruitingOBSERVATIONAL

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

This study is gathering information on a blood condition called Hemolytic Disease of the Fetus and Newborn (HDFN). HDFN happens when a mother's blood type is incompatible with her baby's, causing the baby's red blood cells to break down too quickly. Researchers are observing pregnant people at risk for HDFN and their babies to see how often babies develop anaemia (low red blood cells). This is a 'non-interventional' study, meaning participants will receive their usual medical care, and no new treatments or tests are being given as part of the study. The aim is to better understand HDFN and how it affects babies.

At a glance

Status

Recruiting

Sponsor

Janssen Research & Development, LLC

Enrolment target

175

Start

17 Dec 2025

Estimated completion

30 Sep 2030

Hemolytic Disease of the Fetus and Newborn

What is this study about?

This study is about a condition called Hemolytic Disease of the Fetus and Newborn, or HDFN. This happens when a pregnant person's blood type doesn't quite match their baby's. When this incompatibility occurs, the pregnant person's immune system can sometimes make special proteins (called antibodies) that attack the baby's red blood cells. Red blood cells are very important because they carry oxygen around the body. If too many of a baby's red blood cells are destroyed, the baby can develop anaemia, which means they don't have enough oxygen.

Researchers want to learn more about how often babies develop anaemia in these situations. They are collecting information from medical records of pregnant people who are at risk of HDFN and are receiving their standard care. This is an 'observational' study, meaning doctors won't be giving any new medicines or treatments specifically for the study. Instead, they will be watching and recording what usually happens.

The main goal is to understand the risks of anaemia in babies affected by HDFN. By gathering more information, medical professionals can get a clearer picture of this condition, which could help them improve care for pregnant people and their babies in the future.

Key takeaways

This study helps understand HDFN, a blood condition affecting babies.
It's an 'observational' study, meaning you’ll receive standard care.
No new treatments or tests will be given as part of the study.
Researchers will use existing medical information.
The goal is to improve future care for babies with HDFN.
Your privacy will be protected.

Who may be eligible?

To join this study, you need to be pregnant and no further than 24 weeks along. You must also have a history of a previous pregnancy where your immune system made antibodies against your baby's blood (this is called an alloimmunized pregnancy). This might mean your previous baby had anaemia diagnosed before birth, needed blood transfusions, or had other related issues like a positive direct antiglobulin test (DAT) after birth.

You also need to have these antibodies present in your blood during your current pregnancy, as confirmed by laboratory tests. Furthermore, your current baby must have the specific blood factor that your antibodies react against. This can be checked through tests on your baby's DNA or by checking the baby's father's blood type. You also need to agree to share your medical information and that of your baby for the study.

However, you can't join if you are already taking part in another study that involves an experimental treatment. You also can't join if the only blood type incompatibility you have in this pregnancy is related to the ABO blood group system (like A, B, O types), unless there's another blood group incompatibility as well.

Quick self-check

Are you currently pregnant and less than 24 weeks along?
Have you had a previous pregnancy where your body made antibodies against your baby's blood (an alloimmunized pregnancy)?
Have your doctors found these specific antibodies in your blood during your current pregnancy?
Has it been confirmed that your baby's blood type matches what your antibodies react to?
Are you happy for your medical information (and your baby's) to be used for research?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you take part in this study, you won't need to do anything differently from your usual medical care. There are no extra visits, assessments, or medications. The study simply involves researchers looking at information that's already collected during your routine pregnancy check-ups and your baby's care after birth. This means there's no additional time commitment from you. Your medical team will continue to monitor you and your baby as they normally would, based on your specific situation. The study will just use this information to learn more about HDFN.

Potential risks and benefits

There are generally no direct risks to you or your baby from participating in this study, as it only involves reviewing existing medical records. You won't receive any new treatments or tests specifically for the study. The potential benefit is that the information gathered could help doctors better understand HDFN, possibly leading to improved care for future individuals and babies with this condition. You have the right to withdraw your consent for your data to be used at any time, without it affecting your medical care.

Locations (12)

Riley Children s Hospital
Indianapolis, United States· Recruiting
University of Cincinnati
Cincinnati, United States· Recruiting
Oregon Health And Science University
Portland, United States· Recruiting
Baylor College of Medicine
Houston, United States· Recruiting
The Royal Women's Hospital
Parkville, Australia· Recruiting
Mater Misericordiae Ltd
South Brisbane, Australia· Recruiting
Universitair Ziekenhuis Leuven
Leuven, Belgium· Recruiting
Interdiszip Schwerpunkt fur Hamostaseologie
Giessen, Germany· Recruiting
Mangiagalli Clinic IRCCS Ca Granda Foundation Ospedale Maggiore Policlinico
Milan, Italy· Recruiting
Fondazione Policlinico Universitario A Gemelli IRCCS
Roma, Italy· Recruiting
Hosp Univ Vall D Hebron
Barcelona, Spain· Recruiting
Birmingham Women's Hospital
Birmingham, United Kingdom· Recruiting

Common questions

What is anaemia in babies?

Anaemia means a baby has too few red blood cells. Red blood cells are important because they carry oxygen around the body.

What does 'non-interventional study' mean?

It means the study observes what usually happens without giving any new treatments or changing your standard medical care.

Will I have extra doctor's appointments?

No, taking part in this study doesn't require any extra doctor's appointments or tests beyond your usual pregnancy care.

How will my information be used?

The information will be used by researchers to learn more about HDFN and how it affects babies, which could help improve future treatments.

Can I leave the study if I change my mind?

Yes, you can decide to stop participating at any time without it affecting your medical care.

How to find out more

Study Contact

Participate-In-This-Study1@its.jnj.com 844-434-4210 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.