跳至主要内容
临床试验/CTRI/2024/05/067214
CTRI/2024/05/067214尚未招募不适用

The predictability of Neonatal Lung Ultrasound Score for surfactant therapy in preterm neonates with respiratory distress-a prospective observational study

K S Sivakumar1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年5月24日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
To assess the accuracy of Lung Ultrasound Score in preterm neonates with respiratory distress in predicting the need for surfactant therapy based on European Consensus Guidelines on the Management of Respiratory Distress Syndrome

研究概览

简要总结

1.Neonatal lung ultrasound has become an indispensable bedside tool in Neonatology in recent years as it is quick, radiation-free, minimally invasive and holds the characteristics of a point-of-care technique.

  1. A lung ultrasound can be used to easily diagnose respiratory distress syndrome, and a semiquantitative score based on ultrasound findings may reveal lung aeration.

  2. The objective of our study is to assess the diagnostic accuracy of a neonatal-adapted LUS score to evaluate the need for surfactant administration in preterm neonates with respiratory distress.

4.Now Fio2 requirement is the main factor for deciding surfactant need as per European consensus guideline 2019. By assessing ultrasound score and comparing with Fio2 requirement lung ultrasound score can be used as primary diagnostic in future NICU.

研究设计

研究类型
Observational

入排标准

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

入选标准

  • All preterm neonates born at <34 weeks of gestation with respiratory distress and requiring some form of respiratory support (mechanical ventilation, continuous positive airway pressure, high flow humidified nasal cannula) to maintain target blood oxygen saturation levels and admitted within 48 hours of life will be enrolled in the study group after informed consent from the parents/ guardians.

排除标准

  • Neonates with 1.Chromosomal abnormalities or complex congenital malformations
  • Congenital lung diseases
  • Neonates with surgical comorbidities
  • Congenital heart defects
  • Delivery room surfactant administration.

结局指标

主要结局

To assess the accuracy of Lung Ultrasound Score in preterm neonates with respiratory distress in predicting the need for surfactant therapy based on European Consensus Guidelines on the Management of Respiratory Distress Syndrome

时间窗: 6hours, 12 hours, 18hours and 24 hours of surfactant administration.

次要结局

  • 1. To predict need for surfactant retreatment based on initial & subsequent LUS score(2.To assess the diagnostic accuracy of LUS for RDS in different gestational age groups)

研究者

发起方
K S Sivakumar
申办方类型
Other [self]

研究点 (1)

Loading locations...

相似试验