跳至主要内容
临床试验/NCT04359134
NCT04359134Unknown不适用

Combined Evaluation of Pulmonary Fluids by Lung Ultrasounds and Transthoracic Electrical Bioimpedance in Preterm Infants With Respiratory Distress Syndrome

IRCCS Azienda Ospedaliero-Universitaria di Bologna2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2020年3月10日最近更新:
适应症

试验速览

阶段
不适用
入组人数
60
试验地点
2
主要终点
Correlation between TFC and lung ultrasound score

研究概览

简要总结

Respiratory distress syndrome (RDS) is among the most common complications of preterm birth, and typically becomes manifested soon after birth. A failure of the rapid reuptake of fetal lung fluids after birth, with subsequent liquid retention in the alveolar space, together with the deficit of surfactant proteins ensuing from lung immaturity represent the leading mechanisms for the development of RDS, which may require different levels of respiratory support.

An increasingly used method for the evaluation of the neonatal lung is pulmonary ultrasound, which allows assessing alveolar fluids and other pathological conditions in a non-invasive manner, and has been shown to predict the need for respiratory support and for surfactant administration in preterm infants with RDS. However, this method requires specific training, is operator-dependent and does not provide a trend able assessment over time.

Transthoracic electrical bioimpedance (TEB) allows continuous and non-invasive monitoring of static and dynamic thoracic fluids. It has been recently introduced in neonatal clinical practice to assess such hemodynamic parameters as cardiac output and also quantifies static thoracic fluids contents (TFC). This method provides continuous and non-operator dependent data on the pulmonary fluid status over time and does not require specific training.

The combination of lung ultrasound with TEB could open to new diagnostic and prognostic perspectives in preterm infants with RDS.

详细描述

Introduction Respiratory distress syndrome (RDS) is among the most common complications of preterm birth, and typically becomes manifested soon after birth. The rapid reuptake of fetal lung fluids plays an important role in transitional events at birth. Most of this fluid is reabsorbed through epithelial alveolar cells by an active sodium transporter. Mechanical events play a role in this exchange too. A failure of the rapid reuptake of fetal lung fluids after birth, with subsequent liquid retention in the alveolar space, together with the deficit of surfactant proteins ensuing from lung immaturity represent the leading mechanisms for the development of RDS, which may require different levels of respiratory support, ranging from mechanical ventilation to less invasive modalities (nasal cannulas or continuous positive airway pressure (CPAP)).

An increasingly used method for lung evaluation in the newborn is lung ultrasound, which allows to evaluate the alveolar fluid and to differentiate among several pathological conditions (transient tachypnea of the newborn, meconium aspiration, respiratory distress syndrome, pneumothorax, and pleural effusion) and, in the preterm population, has also been proved to predict of the need for respiratory support and for surfactant administration. Compared to traditional radiological assessments, this non-invasive technique does not imply the use of X-ray; however, it requires specific training, it is operator-dependent and does not allow a continuous and trend able evaluation over time, but only serial assessments.

Transthoracic electrical bioimpedance (TEB) allows continuous, non-invasive and real-time monitoring of static and dynamic thoracic fluids. It has been recently introduced in neonatal clinical practice to monitor such hemodynamic parameters as cardiac output, providing useful clinical information in hospitalized preterm infants, or neonates undergoing hemodynamic procedures. This technique allows quantifying static thoracic fluid contents (TFC) in a non-invasive and continuous manner. Compared to ultrasound, this method provides continuous and non-operator dependent data on the lung fluid status over time and does not require specific training for its use and interpretation.

Current literature reported a significant correlation between TFC values and respiratory distress, but, to date, it has not been investigated whether this parameter may predict RDS evolution, or if it is influenced by specific neonatal characteristics associated with pulmonary overflow, such as the presence of a patent ductus arteriosus (PDA), which is a common finding over the transitional period, defined as the first 72 hours of life.

Combining lung ultrasound to transthoracic electrical bioimpedance could open to new diagnostic and prognostic perspectives in preterm infants with RDS during the first days of life.

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 7 Days(Child)
性别
All
接受健康志愿者

入选标准

  • 0-24 hours of life,
  • gestational age ≤34 weeks' gestation
  • diagnosis of respiratory distress
  • written informed consent obtained from parents/legal guardians of each infant.

排除标准

  • major congenital malformations, including congenital heart disease
  • meconium aspiration
  • pneumothorax
  • perinatal asphyxia/hypoxic-ischemic encephalopathy
  • concomitant use of experimental drugs

结局指标

主要结局

Correlation between TFC and lung ultrasound score

时间窗: 48-72 hours of life

Pearson correlation analysis between TFC values and lung ultrasound score

Correlation between lung ultrasound score and RDS evolution

时间窗: 48-72 hours of life

Pearson correlation analysis between the score of lung ultrasound and RDS evolution over the next 24 hours (defined by the need for surfactant or a step-up in the type of respiratory support).

Correlation between TFC and RDS evolution

时间窗: 48-72 hours of life

Pearson correlation analysis between TFC values and RDS evolution over the next 24 hours (defined by the need for surfactant or a step-up in the type of respiratory support).

次要结局

  • Changes in TFC values and lung ultrasound score between time periods with patent and closed ductus arteriosus(0-72 hours of life)

研究者

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

Silvia Galletti

Assistant Researcher

IRCCS Azienda Ospedaliero-Universitaria di Bologna

研究点 (2)

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