Actively Recruiting

Age: 0Days - 6Months
All Genders
NCT03848923

Impact of Thrombocytopenia and Platelet Transfusions on Neonatal Bleeding and Inflammation

Led by Boston Children's Hospital · Updated on 2024-05-16

160

Participants Needed

2

Research Sites

367 weeks

Total Duration

On this page

Sponsors

B

Boston Children's Hospital

Lead Sponsor

B

Beth Israel Deaconess Medical Center

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Impact of Thrombocytopenia and Platelet Transfusions on Neonatal Bleeding and Inflammation

Who Can Participate

Age: 0Days - 6Months
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Have a post-menstrual age between 23 and 44 weeks
  • Have a platelet count less than 100 x 10^9/L
  • Have a parent or guardian willing to provide written informed consent
Not Eligible

You will not qualify if you...

  • Not expected to survive for more than 5 days as assessed by the Attending Neonatologist
  • Suspected congenital thrombocytopenia or platelet dysfunction based on family history or clinical signs
  • Currently on extracorporeal membrane oxygenation (ECMO)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States, 02215

Actively Recruiting

2

Boston Children's Hospital

Boston, Massachusetts, United States, 02215

Actively Recruiting

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Research Team

M

Martha Sola-Visner, MD

CONTACT

V

Vanessa J Young, RN, BA

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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