Recruiting

Thrombocytopenia & Platelet Transfusions

Sponsor:

Boston Children's Hospital

Code:

NCT03848923

Conditions

Neonatal Thrombocytopenia

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

Study Details

Brief 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.

Conditions

Neonatal Thrombocytopenia

Study ID

NCT03848923

Start date

Aug 19, 2019

Status verified date

May, 2024

Completion date

Sep 1, 2026

Anticipated

Primary completion date

Mar 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

160 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

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

Central Contacts and Locations

Locations

Beth Israel Deaconess Medical Center

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Camilia Martin, MD

cmartin1@bidmc.harvard.edu

Boston Children's Hospital

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

More Information

Sponsor

Boston Children's Hospital

Last update posted

May 16, 2024

Last verified

May, 2024

Keywords

  • Thrombocytopenia
  • Neonates
  • Platelets
  • NET Formation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Boston Children's Hospital on 2024-05-16.