Clinical Determinants of Cerebrovascular Reactivity in Very Preterm Infants During the Transitional Period
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
- 否
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
Luigi Corvaglia
Associate Professor
IRCCS Azienda Ospedaliero-Universitaria di Bologna
