Impact of Thrombocytopenia and Platelet Transfusions on Neonatal Bleeding and Inflammation

Description

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.

Conditions

Neonatal Thrombocytopenia

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Study Overview

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Study Details

Study overview

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.

Impact of Thrombocytopenia and Platelet Transfusions on Neonatal Bleeding and Inflammation

Impact of Thrombocytopenia and Platelet Transfusions on Neonatal Bleeding and Inflammation

Condition
Neonatal Thrombocytopenia
Intervention / Treatment

-

Contacts and Locations

Boston

Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States, 02215

Boston

Boston Children's Hospital, Boston, Massachusetts, United States, 02215

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • 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).

Ages Eligible for Study

0 Days to 6 Months

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Boston Children's Hospital,

Martha Sola-Visner, MD, PRINCIPAL_INVESTIGATOR, Boston Children's Hospital

Study Record Dates

2026-09-01