The Neonatal Hemorrhagic Risk Assessment in Thrombocytopenia

Launched by KAROLINSKA INSTITUTET · Oct 16, 2020

Keywords

ClinConnect Summary

This clinical trial is studying the risk of bleeding in premature babies who have low platelet counts, a condition known as neonatal thrombocytopenia. Researchers want to find out if certain measurements, like the Immature Platelet Fraction and bleeding time, can help predict which babies might be at higher risk for bleeding. This information could improve how doctors care for these vulnerable infants in the Neonatal Intensive Care Unit (NICU).

To be eligible to participate, babies must be born before 32 weeks of pregnancy and weigh at least 500 grams. They also need to have a platelet count below 100,000 platelets per microliter of blood. A parent or guardian must agree to provide written consent for their participation. During the trial, participants will undergo tests to measure their platelet count and bleeding time, helping researchers gather important data. It's important to note that babies who are not expected to survive for more than 24 hours or have certain inherited conditions affecting their platelets will not be included in this study.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Have a gestational age \<32 weeks and a birth weight ≥500 grams;
• • Have a platelet count \<100 x 109/L; and
• • Have a parent/guardian willing to provide written informed consent.
• Exclusion Criteria:
• • Are not expected to survive for \>24 hours by the Attending Neonatologist;
• • Are thought to have a familial thrombocytopenia or platelet dysfunction, based on family history or clinical presentation (associated congenital malformations, platelet morphology).