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临床试验/NCT06606015
NCT06606015已完成不适用

Noninvasive Hemodynamics Assessment of Preterm Newborns With Successful Medical Closure of Patent Ductus Arteriosus

Tanta University1 个研究点 分布在 1 个国家目标入组 43 人开始时间: 2023年10月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
43
试验地点
1
主要终点
Stroke volume (SV)

研究概览

简要总结

The aim of our study was to use Electrical Cardiometry EC to monitor hemodynamic alternations during pharmacological closure of hemodynamically significant patent ductus arteriosus (hsPDA) in preterm neonates

详细描述

PDA in the first three days of life is a normal physiologic remnant in healthy term neonates. Conversely, a PDA in preterm neonates causes significant clinical sequelae as a result from left to right shunting. It is widely recognized that a hemodynamically significant PDA is known to contribute to increased morbidity and mortality. The increase in pulmonary blood flow in the setting of prematurity leads to pulmonary edema, noncompliant lungs, and worsening of respiratory status. Other sequelae of a hemodynamically significant PDA include intraventricular hemorrhage, necrotizing enterocolitis, congestive heart failure, and failure to thrive.

Echocardiography is often used to evaluate hemodynamic significance of PDA. In general, pharmacological closure of PDA is less successful in infants with ductal diameter >2mm. Lower ductal maximum velocity, which is usually associated with a larger PDA or higher pulmonary pressure, is another predictor of treatment failure .

The use of echocardiography to gather meaningful hemodynamic data often necessitates serial assessments that can be tedious and labor-intensive. Electrical cardiometry (EC) is a non-invasive, impedance-based monitor that provides absolute cardiac output estimates in clinical practice. Unlike echocardiography, EC is simple to apply, continuous in measurements and not operator dependent.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
24 Hours 至 7 Days(Child)
性别
All
接受健康志愿者

入选标准

  • All preterm newborns who were admitted throughout the duration of the research.

排除标准

  • Newborn with congenital heart diseases.
  • Newborn with acquired heart diseases (viral myocarditis)
  • Newborn with dysrhythmias
  • Newborn with symptomatic cardiac dysfunction secondary to extra cardiac diseases
  • Newborn with significant pulmonary hypertension or systemic hypertension

研究组 & 干预措施

Responders group:

included 26 preterm infants who successfully responded to medical PDA closure

干预措施: I.V Paracetamol. (Drug)

Responders group:

included 26 preterm infants who successfully responded to medical PDA closure

干预措施: Echocardiography. (Device)

Responders group:

included 26 preterm infants who successfully responded to medical PDA closure

干预措施: Electrical Cardiometry (Device)

Non responders group:

included 17 preterm infants who didn't respond to medical PDA closure

干预措施: I.V Paracetamol. (Drug)

Non responders group:

included 17 preterm infants who didn't respond to medical PDA closure

干预措施: Echocardiography. (Device)

Non responders group:

included 17 preterm infants who didn't respond to medical PDA closure

干预措施: Electrical Cardiometry (Device)

结局指标

主要结局

Stroke volume (SV)

时间窗: 6 months

Electrical cardiometry provides non-invasive hemodynamic monitoring. Electrical cardiometry provided a tool for continuous and non-invasive monitoring of Preterm Newborns with successful medical closure of PDA by evaluating: Stroke volume (SV): higher in non-responders.

Cardiac output (CO)

时间窗: 6 months

Electrical cardiometry provides non-invasive hemodynamic monitoring. Electrical cardiometry provided a tool for continuous and non-invasive monitoring of Preterm Newborns with successful medical closure of PDA by evaluating: Cardiac output (CO): higher in non-responders.

Systemic vascular resistance (SVR)

时间窗: 6 months

Electrical cardiometry provides non-invasive hemodynamic monitoring. Electrical cardiometry provided a tool for continuous and non-invasive monitoring of Preterm Newborns with successful medical closure of PDA by evaluating: Systemic vascular resistance (SVR): higher in responders.

Total fluid content (TFC)

时间窗: 6 months

Electrical cardiometry provides non-invasive hemodynamic monitoring. Electrical cardiometry provided a tool for continuous and non-invasive monitoring of Preterm Newborns with successful medical closure of PDA by evaluating: 3. Total fluid content (TFC): higher in non-responders.

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

Lamiaa Khaled Zidan

Lecturer of Pediatrics

Tanta University

研究点 (1)

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