RECRUITING

Impact of Thrombocytopenia and Platelet Transfusions on Neonatal Bleeding and Inflammation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

Impact of Thrombocytopenia and Platelet Transfusions on Neonatal Bleeding and Inflammation

Quick Facts

Study Start:2019-08-19
Study Completion:2026-09-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03848923

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.

Ages Eligible for Study:0 Days to 6 Months
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. 1. Have a post-menstrual age between 23 and 44 weeks;
  2. 2. Have a PLT count \<100 x 109/L; and
  3. 3. Have a parent/guardian willing to provide written informed consent.
  1. 1. Are not expected to survive for \>5 days by the Attending Neonatologist;
  2. 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. 3. Are on extracorporeal membrane oxygenation (ECMO).

Contacts and Locations

Study Contact

Martha Sola-Visner, MD
CONTACT
617-919-4845
martha.sola-visner@childrens.harvard.edu
Vanessa J Young, RN, BA
CONTACT
617-355-8330
vanessa.young@childrens.harvard.edu

Principal Investigator

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

Study Locations (Sites)

Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
United States
Boston Children's Hospital
Boston, Massachusetts, 02215
United States

Collaborators and Investigators

Sponsor: Boston Children's Hospital

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-08-19
Study Completion Date2026-09-01

Study Record Updates

Study Start Date2019-08-19
Study Completion Date2026-09-01

Terms related to this study

Keywords Provided by Researchers

  • Thrombocytopenia
  • Neonates
  • Platelets
  • NET Formation

Additional Relevant MeSH Terms

  • Neonatal Thrombocytopenia