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临床试验/NCT05842109
NCT05842109招募中不适用

Clinical Value of ETCOc in the Diagnosis and Treatment of ABO Hemolytic Disease of the Newborn

Women's Hospital School Of Medicine Zhejiang University1 个研究点 分布在 1 个国家目标入组 112 人开始时间: 2023年10月31日最近更新:
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适应症

试验速览

阶段
不适用
状态
招募中
入组人数
112
试验地点
1
主要终点
concentration of ETCOc (end tidal carbon monoxide)
研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

A prospective observational cohort study was designed.

  1. Comparing of the clinical indicators between the hemolytic group and the non-hemolytic group,such as End-tidal carbon monoxide corrected for ambient CO(ETCOc),direct antiglobulin test(DAT), the highest total serum bilirubin level and hemoglobin. To explore the role of ETCOc in the diagnosis of neonatal ABO hemolytic disease.
  2. Comparing of the clinical indicators between the neonates with IVIG treatment and the neonates without IVIG treatment in ABO hemolytic disease, such as ETCOc,total serum bilirubin level before IVIG treatment and ETCOc,total serum bilirubin level after IVIG treatment.To explore the clinical value of ETCOc in the treatment of ABO hemolytic disease.

详细描述

A prospective observational cohort study was designed. The participants included in the study are the neonates with hyperbilirubinemia in ABO incompatibility.Because the serological results are not known at the time of enrollment, all the neonates should be suspected hemolysis. According to the serological results,the neonates are divided into two groups, hemolytic group and non-hemolytic group. All the relevant clinical indicators need to be recorded and each neonates needs follow-up.

研究设计

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

入排标准

年龄范围
— 至 7 Days（Child）
性别
All
接受健康志愿者
否

入选标准

  • •gestational age between 35+0 and 41+6 weeks
  • •birth weight ≥ 2500 grams
  • •respiratory rate < 60 breaths per minute
  • •the neonates admitted to the neonatology department for phototherapy because of hyperbilirubinemia that conforms to the guideline of the experts consensus on the management of neonatal hyperbilirubinemia(2014,in China.)
  • •ABO group incompatibility between the mother and newborn
  • •the informed consent are obtained.

排除标准

  • •persistent dyspnea or need for respiratory support
  • •skin damage or structural deformity around the nasal cavity
  • •receive intensive care treatment in the neonatal intensive care unit(NICU)
  • •Severe congenital malformation, chromosomal or genetic abnormality

结局指标

主要结局

concentration of ETCOc (end tidal carbon monoxide)

时间窗: through study completion, planned to be 1.5 year

ETCOc in ppm

次要结局

  • concentration of bilirubin(through study completion, planned to be 1.5 year)
  • result of DAT(through study completion, planned to be 1.5 year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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Clinical Value of ETCOc in the Diagnosis and... | 临床试验