Reporting of management and outcomes in the hemolytic disease of the fetus and newborn: a systematic literature review

Objective
This systematic literature review aimed to identify outcomes and provide a foundation for the development of a core outcome set in HDFN applicable for use in future clinical trials.

Study design
The bibliographic databases MEDLINE, Embase, EBM Reviews, and EconLit were searched from 2005 until 2023. Primary research studies were included. Outcomes were systematically extracted from the publications’ abstract and categorized into maternal, obstetric, neonatal, long-term, and patient-reported outcomes (PROs).

Results
238 included studies reported 104 different outcomes. Outcomes related to HDFN-specific treatments were the most frequently reported across studies. Long-term outcomes as well as PROs were underutilized in the screened literature.

Conclusion
This SLR showed that a substantial majority of outcomes reported in HDFN-related studies are clinically-centred. PROs and long-term outcomes beyond the neonatal phase are rarely reported in the current literature emphasizing the need to better incorporate those into future clinical practice.

Contributors

EJT Verweij, Enrico Lopriore, Marie Fitzgibbon, Jenny Noack, Thomas Wilke, Wim Noel & Jeanine van Klink

Publication

Journal: Journal of Perinatology
Volume: 45
Issue:
Pages: 1513 - 1519
Year: 2025
DOI: 10.1038/s41372-025-02366-2

Further Study Information

Current Stage: Completed
Date:
Funding source(s): This study was funded by the Janssen Pharmaceutica NV.


Health Area

Disease Category: Neonatal care

Disease Name: Hemolytic disease of the fetus and newborn (HDFN)

Target Population

Age Range: 0 - 100

Sex: Either

Nature of Intervention: Any

Stakeholders Involved

Study Type

- Systematic review of outcomes measured in trials

Method(s)

- Systematic review