Impact of Thrombocytopenia and Platelet Transfusions on Neonatal Bleeding and Inflammation
Boston Children's Hospital
160 participants
Aug 19, 2019
OBSERVATIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria3
- Have a post-menstrual age between 23 and 44 weeks;
- Have a PLT count <100 x 109/L; and
- Have a parent/guardian willing to provide written informed consent.
Exclusion Criteria4
- Are not expected to survive for >5 days by the Attending Neonatologist;
- Are thought to have a congenital thrombocytopenia or platelet dysfunction, based on family history or clinical presentation (e.g. congenital malformations, platelet morphology); or
- Are on extracorporeal membrane oxygenation (ECMO).
- Importantly, patients will be consented when they have a platelet count <100 x 109/L, but they will enter study only when the platelet count falls to <50 x 109/L.
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Locations(2)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT03848923