Impact of Thrombocytopenia and Platelet Transfusions on Neonatal Bleeding and Inflammation

Launched by BOSTON CHILDREN'S HOSPITAL · Feb 19, 2019

Keywords

ClinConnect Summary

This clinical trial is looking at how low platelet counts in newborns, a condition called neonatal thrombocytopenia, affect their risk of bleeding and inflammation. Researchers want to find out if certain measurements of immature platelets can better predict bleeding than just looking at the total platelet count. They also want to understand how platelet transfusions, which are given to help with low platelet levels, impact bleeding and inflammation in these babies.

To participate in this study, newborns need to be between 23 and 44 weeks post-menstrual age and have a platelet count lower than 100,000 per microliter of blood. A parent or guardian must also agree to take part by giving written consent. While the study is currently recruiting, babies will only officially join when their platelet count drops below 50,000. Families can expect to be closely monitored during the study, and the information gathered will help improve understanding and treatment of this condition in newborns.

Gender

ALL

Eligibility criteria

• 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 x 109/L, but they will enter study only when the platelet count falls to \<50 x 109/L.