Neonatology Fellow University of Louisville School of Medicine Louisville, Kentucky, United States
Background: Neonatal pulmonary hemorrhage (PH) is a well described condition that typically occurs in the first several days of life. However, the etiology of PH is unknown and the incidence of PH ranges from 1 to 12 per 1,000 life birth but significantly rises to 50 per 1,000 live births in very-low-birthweight (VLBW, < 1500g) and extremely-low-birthweight (ELBW, < 1250g) populations. PH contributes to significant morbidity and mortality. There have been no clear protective interventions identified except for case reports of antenatal glucocorticoid exposure and post-natal prophylactic indomethacin. There are various strategies around management of acute PH that focus on mitigation of hemorrhage, adequate ventilatory support, stabilization of hemodynamics, and prevention of recurrence. Despite these strategies mortality rates have been reported as high as 65%. Recombinant activated factor VIIa (rFVIIa) has FDA approval for the treatment of acute hemorrhage in pediatric and adult patients with hemophilia A and B. The utilization of rFVIIa in neonatal pulmonary hemorrhage and other refractory bleeding infants has been described in small case studies with reports of decreased time to hemorrhage cessation. Objective: To evaluate the efficacy of rFVIIa for the treatment of acute PH in VLBW neonates. Secondary objectives are to evaluate the clinical outcomes of neonates treated with rFVlla after PH in comparison to neonates treated with conventional therapy. Design/Methods: This retrospective study was reviewed and approved through our institutional IRB. Patients (n=98) admitted to a single center neonatal intensive care unit with PH between January 2012-December 2016 and patients with PH treated with rFVIIa between January 2017-December 2022. Exclusion criteria included patients < 30 days of age, < 23-weeks gestational age, rFVIIa was needed for other indications or evidence of underlying bleeding disorder. Currently, data collection is complete and statistical analysis utilizing parametric and non-parametric testing will be complete by the end of November, 2023.
