跳至主要内容
临床试验/CTRI/2018/09/015809
CTRI/2018/09/015809进行中(未招募)不适用

Assessing myocardial strain pattern in a cohort of preterm neonates - A prospective observational study.

SRMC and RI1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2018年9月25日最近更新:

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
100
试验地点
1
主要终点
BPD

研究概览

简要总结

Assessment of myocardial function in neonates by strain analysis in echocardiography is a relatively new method. Although strain analysis is an established tool for myocardial function assessment in adults, it’s feasibility, application and interobserver variability are not studied in preterm neonates. We aim to study myocardial function in preterm neonates 32 weeks or less using this tool. Prospectively 100 neonates admitted to our Nicu will be studied at birth and then at multiple time points 1 week, 2 week, and then at 34 weeks. While echocardiography studies are performed at prespecified time points, strain analysis will be done only after the baby is discharged in an offline mode using the software q lab in a computer. The normal pattern of strain at various time points will be noted, and also whether strain pattern correlates with some major neonatal morbidities like BPD, hemodynamically significant PDA, need for transfusions, sepsis episodes with initropes requirement will be studied. Some of the study loops will be analysed for strain pattern by an external investigator and interobserver variability will be calculated.

研究设计

研究类型
Observational

入排标准

年龄范围
1.00 Day(s) 至 28.00 Day(s)(—)
性别
All

入选标准

  • Preterm neonates 32 weeks and less.

排除标准

  • Major congenital malformations.
  • First study not performed within 72 hours.

结局指标

主要结局

BPD

时间窗: 34 week pma or dischargewhich ever is later

Hemodynamicaly significant PDA

时间窗: 34 week pma or dischargewhich ever is later

Death.

时间窗: 34 week pma or dischargewhich ever is later

Need for transfusion

时间窗: 34 week pma or dischargewhich ever is later

Need forinotropes during sepsis epsiodes

时间窗: 34 week pma or dischargewhich ever is later

次要结局

  • Duration of NICU stay(Duration of ventilation)

研究者

发起方
SRMC and RI
申办方类型
Private medical college

研究点 (1)

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