RecruitingNot Applicable

Impact of Thrombocytopenia and Platelet Transfusions on Neonatal Bleeding and Inflammation

United States160 participantsStarted 2019-08-19

Plain-language 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.

Who can participate

Age range0 Days – 6 Months

SexALL

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Inclusion criteria

✓. 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 criteria

✕. 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).

What they're measuring

Assessment of the bleeding score using the Neo-BAT (Neonatal Bleeding Assessment Tool),

Timeframe: Approximately 3 years

Trial details

NCT IDNCT03848923

SponsorBoston Children's Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-03-01

Contact for this trial

Martha Sola-Visner, MD

617-919-4845 martha.sola-visner@childrens.harvard.edu

View on ClinicalTrials.gov More Neonatal Thrombocytopenia trials