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临床试验/NCT07333599
NCT07333599招募中不适用

Hypoxia Profiles Identified in Term Newborns With Cord pH <7.00

University Hospital, Strasbourg, France2 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2025年4月4日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
400
试验地点
2
主要终点
Apgar score

研究概览

简要总结

Severe neonatal acidosis is an identified risk factor for neonatal encephalopathies and severe neurological sequelae such as cerebral palsy. While intrapartum origin of such deterioration is rare (approximately 20% of adverse outcomes in term infants), screening for hypoxia that can lead to the development of severe acidosis remains inadequate. This results in both delays in diagnosis and/or intervention, and a parallel increase in obstetric interventions (cesarean sections and operative vaginal deliveries) sometimes performed with inappropriate indications, thus contributing to unnecessary maternal and neonatal comorbidities. Difficulties in analyzing fetal heart rate (FHR) patterns are identified as an independent risk factor, particularly due to significant inter- and intra-observer variability, in an examination that is nevertheless central to assessing fetal well-being during labor. An FHR analysis based on a thorough understanding of the physiology of fetal adaptation to hypoxia could allow for better recognition of situations where fetal compensation for hypoxic stress is no longer possible, when adaptive mechanisms are exhausted. Given that FHR interpretation errors are implicated in 35 to 50% of adverse neonatal outcomes (peripartum death, early neonatal death, or irreversible brain damage), the preventability of these traumatic complications for families is systematically called into question. Furthermore, recent data suggest that defining hypoxia profiles associated with tracing characteristics would allow for more accurate identification of these situations, and for improved use of intervention in a more appropriate manner in terms of time and resources, in an attempt to reduce the incidence of neonatal complications of hypoxic origin involved in the development of severe neurological sequelae.

研究设计

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

入排标准

年龄范围
0 Days 至 1 Day(Child)
性别
All
接受健康志愿者

入选标准

  • Adult woman (≥ 18 years)
  • Treated at Strasbourg University Hospital between January 1, 2014, and December 31, 2024
  • Singleton pregnancy
  • Cord arterial pH < 7.00

排除标准

  • Gestational age < 37 weeks
  • Known congenital malformation
  • Intrauterine fetal death diagnosed upon admission
  • No cardiotocographic recording

结局指标

主要结局

Apgar score

时间窗: The score is measured 1 minute and 5 minutes after birth.

Apgar score: * 7 to 10 points: Healthy baby * 4 to 6 points: The baby needs some help (oxygen, stimulation, etc.) * 0 to 3 points: Urgent situation; the baby needs immediate care

次要结局

未报告次要终点

研究者

发起方
University Hospital, Strasbourg, France
申办方类型
Other
责任方
Sponsor

研究点 (2)

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