Objective: Massive hemorrhage with shock is a common problem for the intensivist. The use of recombinant activated factor VII (rFVIIa), known as efficient treatment for hemophilia, has been reported to control severe bleeding episodes in critically care patients, but never in preterm neonates. Design: Case report (two cases) and review of the literature. Setting: Neonatal intensive care unit, university teaching hospital. Patients: Two preterm neonates with life-threatening hemorrhages, from the liver and spleen in one patient and from the lung in the other. Intervention: Intravenous administration of 150/200 μg/kg of rFVIIa (Novoseven, NovoNordisk, Copenhagen, Denmark). Measurements and results: Complete hemostasis 10 min after the second bolus in the two patients. Conclusion: For the intensivist, the successful use of rFVIIa in these patients and others lacking pre-existing coagulopathies points to rFVIIa as a novel therapeutic approach for patients presenting with massive life-threatening hemorrhage.