Effects of low platelet counts and transfusions on bleeding in newborns
Impact of Thrombocytopenia and Platelet Transfusions on Neonatal Bleeding and Inflammation
This study is testing if new ways to measure platelet levels can better predict bleeding in newborns with low platelet counts and how platelet transfusions affect their bleeding and inflammation.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 160 (estimated) |
| Ages | 0 Days to 6 Months |
| Sex | All |
| Sponsor | Boston Children's Hospital Academic / other |
| Locations | 2 sites (Boston, Massachusetts and 1 other locations) |
| Trial ID | NCT03848923 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate whether the Immature Platelet Fraction percentage (IPF%) and Immature Platelet Count (IPC) are more effective predictors of bleeding in neonates with thrombocytopenia than traditional platelet counts. It will also investigate the impact of platelet transfusions on bleeding, inflammation, and the formation of neutrophil extracellular traps (NETs) in these infants. Data will be collected from enrolled infants, including clinical and laboratory information, to assess outcomes related to bleeding and inflammation. The study will follow infants until their platelet counts stabilize or resolve.
Who should consider this trial
Good fit: Ideal candidates are neonates aged 23 to 44 weeks with a platelet count below 100 x 10^9/L.
Not a fit: Patients who are not expected to survive beyond 5 days or have congenital thrombocytopenia will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the management of neonatal thrombocytopenia and enhance outcomes for affected infants.
How similar studies have performed: Other studies have explored platelet transfusions in neonates, but this specific approach focusing on IPF% and IPC as predictors is novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Boston, Massachusetts and 1 other locations
- Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States (Recruiting)
- Boston Children's Hospital — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Martha Sola-Visner, MD — Boston Children's Hospital
- Study coordinator: Martha Sola-Visner, MD
- Email: martha.sola-visner@childrens.harvard.edu
- Phone: 617-919-4845
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.