Impact of Thrombocytopenia and Platelet Transfusions on Neonatal Bleeding and Inflammation

Conditions

• Neonatal Thrombocytopenia

Eligibility Criteria

Sex

ALL

Age

0 Days - 6 Months

Healthy Volunteers

Not accepted

Study Details

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.

Key Dates

Start date

Aug 19, 2019

Status verified

May 2024

Primary completion

Mar 1, 2026

Completion

Sep 1, 2026

Study Design

Enrollment

160 participants (estimated)

Primary Outcome Measure

Assessment of the bleeding score using the Neo-BAT (Neonatal Bleeding Assessment Tool), [ Time Frame: Approximately 3 years ]

Central Contacts

• Martha Sola-Visner, MD
  617-919-4845
  [email protected]
• Vanessa J Young, RN, BA
  617-355-8330
  [email protected]

Locations (2)

Find similar trials in Boston, MA

Related Studies

• The Neonatal Hemorrhagic Risk Assessment in Thrombocytopenia
  Recruiting · Karolinska Institutet · Boston, Massachusetts