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临床试验/NCT03848923
NCT03848923招募中不适用

Impact of Thrombocytopenia and Platelet Transfusions on Neonatal Bleeding and Inflammation

Boston Children's Hospital2 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2019年8月19日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
160
试验地点
2
主要终点
Assessment of the bleeding score using the Neo-BAT (Neonatal Bleeding Assessment Tool),

研究概览

简要总结

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.

详细描述

This is a prospective observational study designed to contrast the potential positive effects of neonatal platelet transfusion on clinical bleeding vs. their potentially negative effects on NET formation, intravascular thrombosis and elevation of pro-inflammatory cytokines.

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.

After obtaining signed Informed Consent, enrolled infants will undergo the following:

  1. Prospective collection of clinical and laboratory data, including:

  2. Baseline demographic and clinical information from infants and mothers;

  3. Clinical diagnoses at the time of enrollment (if NEC, then Bell's stage) and illness severity (SNAP scores) at the time of diagnosis;

  4. All hemoglobins, hematocrits, PLT counts, IPF% and IPCs obtained during study. An IPF (the PLT equivalent of the reticulocyte count) is automatically run on every thrombocytopenic sample at all participating hospitals, and will provide information regarding mechanism of thrombocytopenia;

  5. All blood culture results, and all markers of liver and renal function;

  6. All PLT, RBC and plasma transfusions, including product characteristics, transfusion times, and volume; and

  7. Neonatal outcomes including IVH (any grade), chronic lung disease (oxygen requirement at 36 wks post-conception), retinopathy of prematurity (any grade), and mortality.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
0 Days 至 6 Months(Child)
性别
All
接受健康志愿者

入选标准

  • Have a post-menstrual age between 23 and 44 weeks;
  • Have a PLT count <100 x 109/L; and
  • Have a parent/guardian willing to provide written informed consent.

排除标准

  • Are not expected to survive for >5 days by the Attending Neonatologist;
  • Are thought to have a congenital thrombocytopenia or platelet dysfunction, based on family history or clinical presentation (e.g. congenital malformations, platelet morphology); or
  • 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.

结局指标

主要结局

Assessment of the bleeding score using the Neo-BAT (Neonatal Bleeding Assessment Tool),

时间窗: Approximately 3 years

The Neo-BAT categorizes bleeding as none (0), minor (1), moderate (2), severe (3), and major (4). A bleeding score will be obtained by the bedside nurse within 2 hours of every PLT count and IPF% checked. NeoBAT scores will include any bleeding since the last PLT count or over the prior 24 hours, whichever is shortest. This will serve to correlate bleeding scores with PLT counts, and to quantify changes following PLT Tx.

次要结局

  • Measurement of changes in cytokine levels and markers of intravascular coagulation and NET formation following PLT Tx(Approximately 3 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Martha Sola-Visner

Associate Professor of Pediatrics

Boston Children's Hospital

研究点 (2)

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