View clinical trials related to Neonatal Thrombocytopenia.
Filter by:Rationale: Preterm neonates with low platelet counts receive prophylactic platelet transfusions with the aim to prevent bleeding. However, it is not clear in which cases platelet transfusions reduce the risk of bleeding or whether they do more harm than good. A large, randomized trial showed that the higher platelet count threshold for transfusion was associated with a higher rate of death and major bleeding, which suggests that platelet transfusions caused harm in neonates. To gain insight into the risk/benefits of platelet transfusions, the investigators will validate a recently developed dynamic prediction model for major bleeding in multiple NICUs in Europe and investigate the effects of prophylactic platelet transfusions on the risks of bleeding and potential transfusion-associated adverse events. This model could then be used in future studies to define enhanced indications for transfusion, with the ultimate goal to prevent transfusion-associated harm in this vulnerable population. Objectives: 1. Validation of the existing dynamic prediction model in an international cohort of preterm neonates with severe thrombocytopenia (platelet count <50x10^9/L) admitted to a NICU. 2. Model amendment to enable prediction of bleeding risks under various hypothetical platelet transfusion strategies in preterm neonates with severe thrombocytopenia. 3. To examine whether prophylactic platelet transfusions are causally associated with the occurrence of bronchopulmonary dysplasia (BPD), necrotizing enterocolitis (NEC), proven sepsis, retinopathy of prematurity (ROP), major bleeding, and mortality. Study design: Multicenter international retrospective cohort study. Study population: Neonates with a gestational age <34 weeks and a platelet count <50x10^9/L, admitted to a NICU between January 1st 2017 and January 1st 2022. Main study endpoints: Major bleeding, BPD, NEC, proven sepsis, ROP and mortality. Nature and extent of the burden and risks associated with participation, benefit, and group relatedness: Not applicable, as this is a retrospective study.
This is a prospective observational study designed to evaluate Immature Platelet Fraction or Immature Platelet Count and Platelet Function Analyzer-100/200 Closure Time-ADP (in vitro bleeding time) as markers of bleeding risk in thrombocytopenic preterm neonates admitted to the Neonatal Intensive Care Unit.
This is a prospective observational study that was designed with the following two Specific Aims: 1. To determine whether the Immature Platelet Fraction percentage (IPF%) and the Immature Platelet Count (IPC) are better predictors of bleeding than the platelet count alone in neonates of different gestational and post-conceptional ages and with different etiologies of thrombocytopenia; and 2. To characterize the effects of neonatal thrombocytopenia and platelet transfusions (PLT Tx) on bleeding and on markers of systemic inflammation, thrombosis, and neutrophil extracellular traps (NET) formation in neonates with different underlying conditions.