跳至主要内容
临床试验/NCT03866876
NCT03866876Unknown不适用

Umbilical Cord Arterial Eucapnic pH Compared With Arterial pH and Base Deficit as Predictor of Severe Adverse Outcomes Among Term Neonates

Hospices Civils de Lyon1 个研究点 分布在 1 个国家目标入组 36,435 人开始时间: 2018年9月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
36,435
试验地点
1
主要终点
Number of patients with at least one of these criteria including neonatal seizure, neonatal hypotonia requiring intensive care unit admission, neonatal encephalopathy, and/or neonatal death.

研究概览

简要总结

Neonatal asphyxia per partum can be complicated by severe neurologic sequelae and can lead to neonatal death. Of the 0.2% of live births to cerebral palsy, 10 to 28% would be secondary to neonatal acidosis. Only metabolic acidosis plays a neurotoxic role, explaining the recent interest of Racinet et al. in the development of a new biochemical marker, more specific than pH or base deficit, of neonatal asphyxia per partum at risk of anoxo-ischemic encephalopathy. This eucapnic neonatal pH raises the hope of a biochemical marker of situations at risk of poor prognosis, with high diagnostic value, prognostic and forensic.

Our hypothesis is that eucapnic pH is more efficient than cord blood arterial pH and base deficit in the prediction of adverse neurologic outcomes.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

性别
All
接受健康志愿者

入选标准

  • All birth more than 37 weeks of amenorrhea at the maternity ward of the hospital Femme-Mère-Enfant
  • from 1st of january 2000 to 31 december 2016

排除标准

  • Infants born out of the hospital and secondarily hospitalized in the hospital Femme-Mère-Enfant
  • Children with congenital anomalies or without valid arterial and venous umbilical cord samples

结局指标

主要结局

Number of patients with at least one of these criteria including neonatal seizure, neonatal hypotonia requiring intensive care unit admission, neonatal encephalopathy, and/or neonatal death.

时间窗: Between 2000 and 2016

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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