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临床试验/NCT03721640
NCT03721640已完成不适用

Evaluation of the Neonatal Autonomic Stress During Intubations Under Propofol in a Population of Premature Infants Under 33 w'GA

Centre Hospitalier Universitaire de Saint Etienne1 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2019年2月25日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
21
试验地点
1
主要终点
Real-time LF values (low frequency)

研究概览

简要总结

Hyaline membrane disease is one of the leading causes of morbidity and mortality in premature newborns in industrialized countries. For 30 years, the management of the hyaline membranes disease has been transformed by intratracheal administration of exogenous surfactant (Curosurf®) at birth or in the following hours. In order to limit the harmful effects in terms of barotrauma of mechanical ventilation, several methods have been developed over the last decades, aiming at limiting the mechanical ventilation to the profile of non-invasive ventilation: Thus the administration of surfactant has become faster (although invasive) and if possible followed by immediate extubation following the INSURE (INtubation / SURfactant / Extubation) or LISA (Less-Invasive Surfactant Administration) procedure.

Given the fragility of the children concerned and their low weight, this invasive gesture has long been carried out without premedication. However, taking into account the pain induced and potential hemodynamic consequences of the gesture, neonatal societies now recommend the use of anesthetic before intubation, with a short duration sedative.

Propofol is a general anesthetic that combines these conditions and is widely used in pediatric anesthesia.

In that way, since 2016, the invetigators have modified the sedation protocol for intubation in our department and have recommended Propofol as first-line treatment for term and preterm newborn. A lot of study showed its hemodynamic safety in preterms. However, the investigators lack data on the autonomic stress really observed during intubation in this population. The investigators therefore propose to evaluate these physiological data in a non-randomized prospective observational study in premature infants under 33 weeks of gestational amenorrhea (GA), during a sedation protocol for intubation and surfactant administration according the INSURE or LISA technique, with standardized doses of propofol : 1mg/kg for preterm infants with a birthweight less than 1.5kg and 1.5mg/kg for higher birthweight.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
— 至 33 Weeks(Child)
性别
All
接受健康志愿者

入选标准

  • breathing rate > 60 cycles/min
  • Silverman scale > 3 and < 6
  • FiO2 > 30% and < 60%
  • collected consent from parents

排除标准

  • Preterm neonates with Intraventricular hemorrhage grade III & IV
  • Preterm neonates with hemodynamic instability
  • Preterm neonates with congenital heart disease
  • Preterm neonates with severe congenital malformation
  • Preterm neonates already sedated and/or under invasive mechanical ventilation
  • FiO2 > 60%
  • Silverman scale > 6
  • Use of amines for maintaining blood pressure
  • Use of sedatives or analgesics during the last 24 hours (except paracetamol and ibuprofen)

结局指标

主要结局

Real-time LF values (low frequency)

时间窗: during surfactant administration procedure

* represent the well-being sympathetic activity of the autonomic nervous system * measured with electrocardiogram

次要结局

  • heart rate(during surfactant administration procedure)
  • Oxygen saturation(during surfactant administration procedure)
  • systolic arterial blood pressure(during surfactant administration procedure)
  • diastolic arterial blood pressure(during surfactant administration procedure)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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