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临床试验/CTRI/2017/09/009654
CTRI/2017/09/009654尚未招募不适用

Normative values of echocardiographic functional parameters in stable VLBW neonates during first month of life

Manoj Modi1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2017年9月30日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
Manoj Modi
入组人数
200
试验地点
1
主要终点
1 -Left ventricular output

研究概览

简要总结

This is an observational study of echocardiographic functional parameters in very low birth weight neonates admitted to NICU at Sir Ganga Ram hospital, New Delhi. All stable neonates <1500 grams at birth, admitted to NICU within 24 hrs of life will be enrolled and echocardiographic assessment of left ventricular output, right ventricular output, superior vena cava flow, inferior vena cava dimensions, myocardial shortening fraction will be measured at Day 3, 7, 14, 21, 28 and at discharge. Presence of patent ductus arteriosus (PDA) and various parameters of hemodynamic significance of ductus (duct size, flow pattern, duct flow velocity, left atrium to aortic root ratio, turbulance in main pulmonary artery, reversal of flow in post ductal aorta will be noted. spontaneous closure rates of PDA and proportion of neonates requiring pharmacological and surgical intervention for closure of PDA will be noted. Duct closure will be consider neonate is on invasive ventilation with FiO2 >30% and on echocardiograhy :if PDA is low velocity (<1.5 meter/sec) with left atrium to aortic root ratio >1.8.

研究设计

研究类型
Observational

入排标准

年龄范围
0.00 Day(s) 至 30.00 Day(s)(—)
性别
All

入选标准

  • stable very low birth weight neonates admitted to NICU at Sir Ganga Ram hospital, New Delhi within 24 hrs of life.

排除标准

  • perinatal asphyxia
  • need for inotropes
  • MAP > 15 on mechanical ventilation
  • congenital heart disease.

结局指标

主要结局

1 -Left ventricular output

时间窗: day 3, 7, 14, 21, 28, discharge

2 -Right ventricular output

时间窗: day 3, 7, 14, 21, 28, discharge

3 -Superior vena cava flow

时间窗: day 3, 7, 14, 21, 28, discharge

4 -Myocardial shortening fraction

时间窗: day 3, 7, 14, 21, 28, discharge

5 -Inferior vena cava dimensions

时间窗: day 3, 7, 14, 21, 28, discharge

次要结局

  • 1 -Spontaneous closure of PDA(2 -Need for pharmacological closure)

研究者

发起方
Manoj Modi
申办方类型
Other [self]

研究点 (1)

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