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临床试验/NCT04123691
NCT04123691已完成不适用

Cardio-respiratory Events in VLBW Preterm Infants During the Transitional Period: Clinical Features and Impact of Neonatal Characteristics.

IRCCS Azienda Ospedaliero-Universitaria di Bologna1 个研究点 分布在 1 个国家目标入组 32 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
32
试验地点
1
主要终点
Time distribution of CRE

研究概览

简要总结

Cardio-respiratory events (CRE), defined as intermittent episodes of hypoxemia and/or bradycardia, are particularly common among preterm infants. It has been previously shown that CRE result in transient brain hypoxia and hypoperfusion and may represent a possible risk factor for neurodevelopmental impairment and retinopathy of prematurity. The high cardio-respiratory instability typically seen in preterm infants during the first 72 hours of life may influence CRE occurrence, with possible clinical implications. This study aims to characterize CRE features in this transitional period and to evaluate whether specific neonatal and clinical characteristics are associated with different CRE types.

Newborn infants with gestational age (GA) <32 weeks or birth weight (BW) <1500 g are enrolled. Congenital malformations and mechanical ventilation are exclusion criteria. During the first 72 hours, heart rate (HR) and peripheral oxygen saturation (SpO2) are continuously monitored, and an echocardiogram is performed to assess the status of the ductus arteriosus. CRE are clustered into isolated desaturation (ID, SpO2<85%), isolated bradycardia (IB, HR<100 bpm or <70% baseline), combined desaturation and bradycardia (DB, occurrence of the two events within a 60-sec window). According to their duration and SpO2 and/or HR nadir values, CRE are also classified as mild (SpO2 80-84% and HR 80-100 bpm and duration <60 sec), moderate (SpO2 70-79% or HR 80-60 bpm or duration 61-120 sec) or severe (SpO2 <70% or HR <60 bpm or duration >120 sec). A generalized estimating equation (GEE) will be used to examine the impact of relevant variables on CRE type and severity.

详细描述

Background Cardio-respiratory events (CRE), defined as intermittent hypoxic and/or bradycardic episodes, are very common among premature infants. The poor respiratory drive, together with the increased metabolic oxygen consumption and the reduced total blood oxygen carrying capacity of this population significantly enhance CRE frequency and severity.

Evidence from animal models has shown that CRE, either alone or combined to specific clinical factors (i.e., intrauterine growth restriction, support modality, need for supplemental oxygen etc.), can trigger oxidative stress, which may contribute to adverse neonatal outcomes. In particular, a significant association between CRE and the development of retinopathy of prematurity (ROP) has been largely established, with evidence of a positive correlation between ROP severity and CRE duration, depth of desaturation, and persistency after 3 to 5 weeks of age. A critical role for CRE on early brain development has also been suggested by several studies showing a relationship between the ensuing hypoxic burden and poor neurodevelopment from early infancy up to early school age. Eventually, a possible association between CRE severity and the development of bronchopulmonary dysplasia has been recently reported in very-low-birth-weight (VLBW) neonates.

Most of the available literature on CRE characteristics, physiological mechanisms and effects in the premature population, however, is based on infants aged 2-weeks or older, while data from the transitional period, defined as the first 72 hours after birth, are scarce.

The transitional period represents a critical phase of physiological adaptation and may affect several organ systems, most notably the heart and the lungs. In particular, the dynamic cardiovascular changes that characterize the transition from fetal to neonatal circulation may enhance preterm infants' cardiorespiratory instability, with possible effects on CRE characteristics. In turn, the hemodynamic and respiratory disturbances that characterize post-natal transition may exacerbate the clinical burden of CRE during this period, with possible clinical implications.

This study aims to characterize CRE during transitional periods in VLBW preterm infants, and to evaluate whether specific neonatal characteristics may have an influence on CRE type and severity.

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 Hour 至 72 Hours(Child)
性别
All
接受健康志愿者

入选标准

  • gestational age <32 weeks and/or birth weight <1500 g

排除标准

  • mechanical ventilation
  • major congenital malformations
  • genetic abnormalities

结局指标

主要结局

Time distribution of CRE

时间窗: 0-72 hours of life

Daily incidence of desaturations, bradycardias and combined events

Effect of neonatal characteristics on CRE type

时间窗: 0-72 hours of life

Generalized estimating equation (GEE) analysis evaluating the effect of GA, uREDF, antenatal steroids, ductal and ventilatory status on CRE type (ID, IB, DB) using multinomial distribution/probit link.

Effect of neonatal characteristics on CRE severity

时间窗: 0-72 hours of life

Generalized estimating equation (GEE) analysis evaluating the effect of GA, uREDF, antenatal steroids, ductal and ventilatory status on CRE severity (mild, moderate and severe) using multinomial distribution/probit link.

Definition of CRE characteristics

时间窗: 0-72 hours of life

Total number of desaturations, bradycardias and combined events

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

Silvia Martini

PhD student

IRCCS Azienda Ospedaliero-Universitaria di Bologna

研究点 (1)

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