Status:
RECRUITING
Impact of Thrombocytopenia and Platelet Transfusions on Neonatal Bleeding and Inflammation
Lead Sponsor:
Boston Children's Hospital
Collaborating Sponsors:
Beth Israel Deaconess Medical Center
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Neonatal Thrombocytopenia
Eligibility:
All Genders
Up to 6 years
Brief 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 Co...
Detailed 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 format...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 19 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 1 2026
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT03848923
Start Date
August 19 2019
End Date
September 1 2026
Last Update
May 16 2024
Active Locations (2)
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1
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
2
Boston Children's Hospital
Boston, Massachusetts, United States, 02215