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临床试验/NCT04423016
NCT04423016已完成不适用

Clinical Determinants of Cerebrovascular Reactivity in Very Preterm Infants During the Transitional Period

IRCCS Azienda Ospedaliero-Universitaria di Bologna1 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2018年2月21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
72
试验地点
1
主要终点
Correlation between TOHRx and gestational age

研究概览

简要总结

The transitional period, defined as the first 72 hours after preterm birth, is often characterized by a significant hemodynamic instability and may also be associated with an impairment of cerebral autoregulation, with relevant clinical implications. The moving correlation coefficient between cerebral oxygenation and heart rate, also defined as TOHRx, has been previously proposed as a marker of cerebrovascular reactivity and provides an indirect estimation of cerebral autoregulation in preterm infants.

This study aims to evaluate whether different antenatal, perinatal and postnatal factors may influence cerebrovascular reactivity in very preterm infants during the transitional period.

详细描述

The transitional period, defined as the first 72 hours after preterm birth, is often characterized by a significant hemodynamic instability and may also be associated with an impairment of cerebral autoregulation, with relevant clinical implications. The moving correlation coefficient between cerebral oxygenation and heart rate, also defined as TOHRx, has been previously proposed as a marker of cerebrovascular reactivity and provides an indirect estimation of cerebral autoregulation in preterm infants.

This prospective observational study aims to evaluate whether different antenatal, perinatal, and postnatal factors may influence cerebrovascular reactivity in very preterm infants during the transitional period.

Infants <32 weeks' gestation are enrolled within 12h from birth. A simultaneous monitoring of cerebral oxygenation (CrSO2) by near-infrared spectroscopy and of heart rate (HR) by pulse oximetry and electrical velocimetry is performed continuously over the first 72h.

The moving correlation coefficient between CrSO2 and HR is calculated using the ICM+ software (Cambridge Enterprise Ltd) using 5-min, 30-point epochs. Time periods with evidence of major artefacts, or with a missing data proportion >50% are excluded from this calculation. Positive TOHRx values will be interpreted as markers of impaired autoregulation.

A screening echocardiogram is routinely performed at the time of enrollment and repeated 6-12 hourly in the presence of a patent ductus arteriosus (PDA) or 12-24 hourly if there is no evidence of PDA. Based on echocardiographic features, the ductal status is classified as follows: no evidence of PDA, restrictive PDA (restrictive shunt pattern and left atrium to aortic root ratio [LA:Ao] ratio <1.5), hemodynamically significant PDA (pulsatile shunt pattern, LA:Ao ratio ≥1.5 or presence of reversed end-diastolic flow either in the descending aorta or in the anterior cerebral artery).

研究设计

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

入排标准

年龄范围
1 Day 至 3 Days(Child)
性别
All
接受健康志愿者

入选标准

  • gestational age <32 weeks' gestation

排除标准

  • major congenital malformations
  • congenital heart disease

结局指标

主要结局

Correlation between TOHRx and gestational age

时间窗: 0-72 hours

Correlation between TOHRx and gestational age

Correlation between TOHRx and antenatal steroids administration

时间窗: 0-72 hours

Correlation between TOHRx and antenatal steroids administration (full course vs. incomplete course or not given)

Correlation between TOHRx and antenatal Doppler status

时间窗: 0-72 hours

Correlation between TOHRx and antenatal Doppler status (normal or abnormal)

Correlation between TOHRx and ductal status

时间窗: 0-72 hours

Correlation between TOHRx and ductal status (hemodynamically significant, restrictive or closed)

Correlation between TOHRx and respiratory support

时间窗: 0-72 hours

Correlation between TOHRx and respiratory support modality (mechanical ventilation, CPAP, nasal cannulas or self-ventilating in air)

Correlation between TOHRx and inotropes

时间窗: 0-72 hours

Correlation between TOHRx and inotropes administration (dopamine; dobutamine; dopamine and dobutamine)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Luigi Corvaglia

Associate Professor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

研究点 (1)

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