In rare cases, a pregnant woman’s immune system can produce antibodies that attack her baby’s red blood cells through a process called maternal alloimmunization. This can lead to Hemolytic Disease of the Fetus and Newborn (HDFN) - a potentially life-threatening condition caused by fetal anemia. HDFN occurs when the baby’s red blood cells are incompatible with the mother’s. The mother’s immune system treats these cells as foreign and produces antibodies that break them down, putting the baby at serious risk.

The study begins with a comprehensive literature review to identify outcomes previously reported in HDFN research. These outcomes are evaluated for their relevance by healthcare professionals (HCPs), patients and parents, as well as regulatory and health technology assessment agencies.

NOMINATE will conduct advisory boards with both HCPs and patients or parents to review these findings and rank the outcomes based on clinical importance, credibility, and real-world applicability.

Following these discussions, a Delphi exercise will help establish consensus on the most meaningful outcomes - those that best capture the disease's impact from both patient and healthcare provider perspectives.

Ultimately, the project aims to integrate these findings into evidence-based strategies that guide future research and clinical practices in the management of HDFN.

The NOMINATE project actively involves patients and families to ensure their voices shape every stage of the research process. This patient-centered approach helps researchers:

• Understand the lived experience of HDFN and how it impacts pregnancy and family planning

   

• Explore patients’ perspectives on treatments and procedures

   

• Identify what outcomes matter most to patients and families

   

• Learn how care delivery and communication can improve for those affected

GFCNI played a key role in ensuring meaningful patient involvement throughout the project by:

• Establishing a standing advisory board of patients and family representatives affected by HDFN

   

• Advising on the research protocol, study design, and effective communication strategies

   

• Providing input on ethical review processes and developing parent questionnaires

   

• Supporting the dissemination and communication of project outcomes

   

• Helping build networks and raise awareness about rare conditions like HDFN

The NOMINATE project is led and funded by Johnson & Johnson Innovative Medicine. GFCNI contributed to the project from February 2023 through May 2024.