Cardiovascular and Cerebrovascular Responses to Cardio-respiratory Events 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
- 42
- 试验地点
- 1
- 主要终点
- Increase/reduction of CO during isolated desaturation, isolated bradycardia and desaturation-bradycardia
研究概览
简要总结
Intermittent episodes of hypoxemia and/or bradycardia, also defined as cardio-respiratory events (CRE) are very frequent in preterm infants and may result in transient hypoxia and hypoperfusion of target organs, with possible clinical implications. The hemodynamic instability that characterizes the first 72 hours of life, also called as transitional period, place preterm infants at high risk of complications and may contribute to enhance fluctuations in end-organ perfusion and oxygenation induced by CRE. In this study we aimed to explore cardiovascular and cerebrovascular changes determined by different CRE types in preterm infants during the transitional period.
详细描述
Intermittent episodes of hypoxemia and/or bradycardia, also defined as cardio-respiratory events (CRE) are very frequent in preterm infants and may result in transient hypoxia and hypoperfusion of target organs, with possible clinical implications. The hemodynamic instability that characterizes the first 72 hours of life, also called as transitional period, place preterm infants at high risk of complications and may contribute to enhance fluctuations in end-organ perfusion and oxygenation induced by CRE. Moreover, during this period, several clinical variables (e.g., antenatal steroid administration, gestational age [GA], patent ductus arteriosus [PDA], respiratory support etc.) may contribute to modulate the hemodynamic fluctuations in response to CRE.
Hence, this study aims:
- to explore changes in the main cardiovascular and cerebrovascular parameters elicited by different CRE types
- to evaluate whether different antenatal, perinatal and postnatal factors may influence the observed cardiovascular and cerebrovascular responses to CRE.
Infants born at S. Orsola-Malpighi Hospital are consecutively enrolled in this observational, prospective study if fulfilling the following eligibility criteria: gestational age (GA) <32 weeks' gestation, birth weight <1500 g, 0-12 hours of life, written informed consent obtained from the parents/legal guardians of each infant.
As routinely performed in infants with the eligible characteristics, the enrolled infants undergo a simultaneous, continuous and non-invasive monitoring of
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 AND/OR birth weight <1500 g
排除标准
- •major congenital malformations
- •congenital heart disease
- •mechanical ventilation
结局指标
主要结局
Increase/reduction of CO during isolated desaturation, isolated bradycardia and desaturation-bradycardia
时间窗: 0-72 hours of life72 hours
Comparison of percentage CO changes (CO at baseline/during the event) among isolated desaturation, isolated bradycardia and desaturation-bradycardia
Increase/reduction of cFTOE during isolated desaturation, isolated bradycardia and desaturation-bradycardia
时间窗: 0-72 hours of life
Comparison of percentage cFTOE changes (baseline/during the event) among isolated desaturation, isolated bradycardia and desaturation-bradycardia
Increase/reduction of cTHI during isolated desaturation, isolated bradycardia and desaturation-bradycardia
时间窗: 0-72 hours of life
Comparison of percentage cTHI changes (baseline/during the event) among isolated desaturation, isolated bradycardia and desaturation-bradycardia
Increase/reduction of ICON during isolated desaturation, isolated bradycardia and desaturation-bradycardia
时间窗: 0-72 hours of life
Comparison of percentage ICON changes (baseline/during the event) among isolated desaturation, isolated bradycardia and desaturation-bradycardia
Increase/reduction of cTOI during isolated desaturation, isolated bradycardia and desaturation-bradycardia
时间窗: 0-72 hours of life
Comparison of percentage cTOI changes (cTOI at baseline/during the event) among isolated desaturation, isolated bradycardia and desaturation-bradycardia
Increase/reduction of SV during isolated desaturation, isolated bradycardia and desaturation-bradycardia
时间窗: 0-72 hours of life
Comparison of percentage SV changes (baseline/during the event) among isolated desaturation, isolated bradycardia and desaturation-bradycardia
Increase/reduction of SVR during isolated desaturation, isolated bradycardia and desaturation-bradycardia
时间窗: 0-72 hours of life
Comparison of percentage SVR changes (baseline/during the event) among isolated desaturation, isolated bradycardia and desaturation-bradycardia
次要结局
- Effect of neonatal characteristics on cerebrovascular parameters(0-72 hours of life)
- Effect of neonatal characteristics on cardiovascular parameters(0-72 hours of life)
研究者
Luigi Corvaglia
Associate Professor, Neonatal Consultant
IRCCS Azienda Ospedaliero-Universitaria di Bologna