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临床试验/NCT04483869
NCT04483869Unknown不适用

Infrared Thermography and Apgar Score: Evaluation in Delivery Room for Term Newborn

Poissy-Saint Germain Hospital1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2020年7月23日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
200
试验地点
1
主要终点
thermographic image

研究概览

简要总结

Background: The Apgar score assesses the newborn's adaptation in the first minutes of life. It is rated between 0 and 10 by the midwife, at 1-3-5 and 10 minutes of life. A low Apgar score at 5 minutes of life is associated with increased neonatal mortality and neurological impairment. However, this score has limitations and its measurement remains subjective: it does not guide resuscitation actions in the event of poor adaptation, significant inter-observer variability in scoring, variations according to the physiological maturation of the newborn, in particular according to gestational age.

Infrared thermography is a rapidly developing imaging technique based on the measurement of infrared radiation. It is an accurate, reliable and easy instrument of providing rapid non-contact, non-invasive and non-irradiating diagnosis. A recent 2018 study showed that the use of thermography would allow accurate and non-invasive monitoring of newborns in neonatal intensive care unit for early diagnosis of certain pathologies such as infection. During the transition, during the first minutes of life, the circulatory and respiratory systems of the newborn change. Vasodilatation occurs progressively in the central and peripheral areas. Thermoregulation is also a crucial stage of adaptation.

In view of this physiopathological knowledge, it seems interesting to correlate this adaptation , with the analysis of thermographic images. The principle of this technique is indeed based on the analysis of the heat emitted, and would thus make it possible to evaluate the blood perfusion of the newborn, and its evolution in the first minutes of life in an objective way. Our hypothesis is that a poor adaptation could be detected more efficiently on photographs taken at time T, contrary to the calculation of the Apgar score for which there are several limitations mentioned above.

Main objective of the study: To study the ability of the thermographic image to objectively evaluate the adaptation to ectopic life of newborns compared to existing evaluations (Apgar, pH, Lactates).

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

入排标准

年龄范围
— 至 15 Minutes(Child)
性别
All
接受健康志愿者

入选标准

  • term infants, gestational age ≥ 37 weeks of gestation
  • cesarean delivery
  • maternal age ≥ 18 years

排除标准

  • parents refusal
  • congenital anomalies

结局指标

主要结局

thermographic image

时间窗: 10 minutes of life

Correlation between thermographic image and Apgar score

次要结局

未报告次要终点

研究者

发起方
Poissy-Saint Germain Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Mathilde Letouzey, MD

Principal investigator

Poissy-Saint Germain Hospital

研究点 (1)

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Infrared Thermography and Apgar Score | 临床试验