Current and future interventions for neonatal lupus: A review of the national library of Medicine’s clinical trials database

Background: Neonatal lupus erythematosus (NLE) is a potentially life-threatening condition resulting from the transfer of autoantibodies from the mother to the fetus, with congenital heart block (CHB) its most serious complication. Despite the potential severity, therapeutic strategies remain limited. The objective was to systematically evaluate all registered clinical trials to date for the treatment or prevention of NLE and its cardiac manifestations. Methods: We searched the Clinicaltrials.gov database on January 24, 2025, to identify all registered clinical trials for NLE treatments since 1994. This online registration of clinical trials is maintained by the NLM, a division of the National Institutes of Health (NIH), and mandates regular trial updates and timely results reporting. The registry provides specifics on a clinical trial, such as a national clinical trial (NCT) number, current recruitment status, study type, and other important data related to the trial. Principal investigators must submit results within 1 year of the trial’s primary completion date. Results: Three eligible trials for NLE were found on the NLM clinical trials database. One trial reported that hydroxychloroquine treatment reduced the recurrence rate of congenital heart block by more than half, from 18% to 7.4%. The remaining studies explored intravenous immunoglobulin and dexamethasone without posting results. Conclusion: Congenital heart block from NLE was decreased in recurrence by treatment with hydroxychloroquine. However, the scarcity of research towards advancing care for these conditions highlights a major gap in this area.