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临床试验/NCT03227536
NCT03227536已完成不适用

Asphyxia at Birth : Evolution of Birth Asphyxia Rate, Etiologies and Neonatal Outcome From 2000 to 2016

Hospices Civils de Lyon1 个研究点 分布在 1 个国家目标入组 61,448 人开始时间: 2017年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
61,448
试验地点
1
主要终点
Rate of Neonatal asphyxia

研究概览

简要总结

This is an historic cohort study based on the birth and delivery register of the HFME maternity ward. This study aim at understanding the evolution of asphyxia at birth, at all gestational ages, identifying causes and describing neonatal outcomes since 2000, when a second line strategy for foetal surveillance (fetal ECG) and systematic umbilical acid-gas cord blood were introduced in our maternity ward.

The investigator's hypothesis was that the neonatal asphyxia decrease could be due to 3 main factors including second line strategy introduction, systematic umbilical cord acid-base implementation and improvement in antenatal risk factor screening for asphyxia. The investigator's second hypothesis was that neonatal prognosis in neonates with acidosis was improved with systematic early after birth EEG evaluation, allowing early treatment and surveillance.

研究设计

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

入排标准

年龄范围
— 至 1 Hour(Child)
性别
All
接受健康志愿者

入选标准

  • All births 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 after medical pregnancy termination and born out of the hospital and secondarily hospitalized in our department will be excluded

结局指标

主要结局

Rate of Neonatal asphyxia

时间窗: 2 months

Neonatal asphyxia define as fetal death, neonatal death, NICU transfer, neonatal seizure, umbilical-artery blood pH ≤ 7.05 with a base deficit ≥ 12 mmol per liter, intubation for ventilation at delivery or neonatal encephalopathy

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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