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Introduction: Life-threatening haemorrhage in neonates is related to high mortality rates. Use of Prothrombin complex concentrate (PCC) in such cases could be significantly valuable because of the low levels of vitamin K-dependent coagulation proteins in neonates and their consumption in case of DIC status. Administration of PCC results in a faster and more effective discontinuation of bleeding, providing time to stabilize the neonate without the risks of fluid overloading and bloodstream infections. Objective:Proposal of an alternative therapeutic approach to intractable bleeding in neonates resistant to conventional haemostatic therapy and compared the clinical outcome of newborns treated with PCC for intractable bleeding or severe coagulation disturbances according to time administrated. Subjects/methods:Data of 39 neonates treated successfully with PCC were retrospectively analyzed. Each patient received a median of 2.1 doses of 25/U of PCC in slow iv push with 12 hrs time-interval. Blood samples for evaluation of coagulation parameters (PT,aPTT,INR) were obtained 1/hr following infusion of each PCC dose. Results:The population consisted of 39 neonates, 14 of them survived (group/A) and 25 died (group/B). There was no difference in BW, GA and bleeding cause or/and site between the 2 groups. In the neonates who survived PCC had been administered earlier in the disease process (within 24 hours of beginning of bleeding) compared to those who died (p=0.048). We observed a statistically significant decrease in PT (from 39.5±41 to 18.7±4.41 prior and after to PCC respectively, p=0.001) and in INR (from 3.67±4.01 to 1.61±0.52 prior and after to PCC respectively, p=0.002). There were no clinical signs of thrombosis or any other adverse effect due to PCC treatment. Conclusion: PCC was safe and efficacious in neonates with intractable bleeding and/or severe coagulation disturbances and PCC was more effective in early intervention as rescue therapy, without any adverse events in all neonates [ABSTRACT FROM AUTHOR]