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临床试验/NCT04348799
NCT04348799已完成不适用

Thrombocytopoiesis and Platelet Homeostasis in Infants With Bronchoplumonary Dysplasia

yangjie1 个研究点 分布在 1 个国家目标入组 96 人开始时间: 2019年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
96
试验地点
1
主要终点
Platelet counts and Circulating MK counts

研究概览

简要总结

To investigate the relationship between bronchopulmonary dysplasia and thrombocytopenia.

详细描述

A prosepective case-control study ,the case were matched with 1:1according to gestational age,birth weight and admission diagnosis and divided into two groups according to the consensus definition of National Institute of Child Health and Human Development (NICHD). Platelet count, circulating megakaryocyte count, platelet activating markers (CD62P and CD63), thrombopoietin were recorded and compared in two groups, then, serial thrombopoietin levels and concomitant platelet counts were measured in infants with BPD.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • presence of clinical and radiologic signs of BPD, according to conventional criteria (Greenough, 1992);
  • presence of peripheral arterial catheter;
  • gestation <32 weeks;
  • birth weight <1.5 kg;
  • requiring mechanical ventilation for the treatment of respiratory distress syndrome for at least 3 days during the first weeks of life;
  • ventilator and/or oxygen dependent at time of enrolment;

排除标准

  • congenital abnormalities;
  • infection (bacteria infection confirmed by positive blood culture or viral infection confirmed by serological test or viral culture)
  • evidence of complications of perinatal asphyxia including an apgar score <3 at one or five minute after birth, evidence of hypoxic-ischemic encephalopathy, acute tubular necrosis, or transient myocardial ischemia;
  • identifiable hematologic disease;

结局指标

主要结局

Platelet counts and Circulating MK counts

时间窗: up to 4 weeks

Platelet counts and Circulating MK counts

次要结局

  • CD62P and CD63 expression(up to 4 weeks)
  • TPO(up to 4 weeks)
  • TPO and platelet(up to 6 weeks)

研究者

发起方
yangjie
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

yangjie

Director of Dept of Neonatology

Guangdong Women and Children Hospital

研究点 (1)

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