Impact of Thrombocytopenia and Platelet Transfusions on Neonatal Bleeding and Inflammation
Boston Children's Hospital
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.
Description
This is a prospective observational study designed to contrast the potential positive effects of neonatal platelet transfusion on clinical bleeding vs. their potentially negative effects on NET formation, intravascular thrombosis and elevation of pro-inflammatory cytokines. 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. After obtaining signed Informed Consent, enrolled infants will undergo the following: 1\. Prospective collection of clinical and laboratory data, including:…
Eligibility
- Age range
- 0–0 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Have a post-menstrual age between 23 and 44 weeks; 2. Have a PLT count \<100 x 109/L; and 3. Have a parent/guardian willing to provide written informed consent. Exclusion Criteria: 1. Are not expected to survive for \>5 days by the Attending Neonatologist; 2. Are thought to have a congenital thrombocytopenia or platelet dysfunction, based on family history or clinical presentation (e.g. congenital malformations, platelet morphology); or 3. Are on extracorporeal membrane oxygenation (ECMO). Importantly, patients will be consented when they have a platelet count \<100…
Locations (2)
- Beth Israel Deaconess Medical CenterBoston, Massachusetts
- Boston Children's HospitalBoston, Massachusetts