Maternal health, neonatology and perinatology towards a standardized outcome set for clinical trials in Hemolytic Disease of the Fetus and Newborn (HDFN): preliminary findings from two European advisory boards.

Enrico Lopriore¹, Maartje Mangelaars², Tom Verbiest³, Wim Noel³, Alexandra Starry⁴, E J T Verweij¹, Katie Morris^5,6

¹Department of Neonatology, Leiden University Medical Centre, Leiden, 2333 ZA, Netherlands.

²Johnson & Johnson, Breda, Netherlands. mmangela@its.jnj.com.

³Johnson & Johnson, Beerse, Belgium.

⁴Cytel, Potsdamer Str. 58, 10785, Berlin, Germany.

⁵Birmingham Clinical Trials Unit, School of Health Sciences, College of Medical and Dental Health, University of Birmingham, Birmingham, B15 2TT, UK.

⁶Department of Fetal Medicine, Birmingham Women's and Children's Hospital, Birmngham, B15 2TG, UK.

PubMed DOI

Abstract

Hemolytic Disease of the Fetus and Newborn (HDFN) remains a serious perinatal condition worldwide despite major advances in antenatal and postnatal care. A key gap in HDFN research is the absence of a standardized outcome set, leading to inconsistent reporting and limited comparability across studies identified during systematic literature review (SLR). Outcomes important to families, such as long…

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