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临床试验/NCT04544514
NCT04544514已完成不适用

Earliest Lung Ultrasound Time for Predicting the Need of Surfactant

Gozdem Kayki0 个研究点目标入组 71 人开始时间: 2017年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
71
主要终点
lung ultrasound at 30 minutes

研究概览

简要总结

Lung ultrasonography (LUS) is fast and easy technique. it also has high reliability, so it has started to be used more in evaluating respiratory distress in the neonatal period. The most important feature of LUS is being radiation-free. Three LUS findings that show respiratory distress syndrome were described. They were white lung appearance, lack of preserved areas and loss of pleural integrity. The sensitivity of these findings was found to be 98-100% and the specificity 92-100%. A few studies have shown that surfactant need can be determined by LUS.

It was observed that lung findings were more severe in LUS performed in the early period because of non-completed fetal lung fluid clearence, but the findings could be improved during follow-up. Therefore, it is not known when the earliest time of LUS shows the actual clinical condition and course of the patient.

This study was planned to find the most reliable and earliest US time. Evaluation with LUS was done at 30 minutes and repeated at 1, 2, 4 and 6 hours of life. The LUS findings would be compared with x-ray findings and the correlation of surfactant need with LUS findings would also be investigated.

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
30 Minutes 至 6 Hours(Child)
性别
All
接受健康志愿者

入选标准

  • preterm babies with a gestational age 32 weeks or less
  • babies treated with CPAP

排除标准

  • If a baby was intubated in delivery room because of the responsiveness to face-mask ventilation, he/she was excluded.
  • congenital heart diseases
  • complex congenital malformations
  • chromosomal abnormalities.

结局指标

主要结局

lung ultrasound at 30 minutes

时间窗: 30 minutes

lung ultrasound findings

lung ultrasound at 1 hour

时间窗: 1 hour

lung ultrasound findings

lung ultrasound at 6 hour

时间窗: 6 hour

lung ultrasound findings

lung ultrasound at 4 hour

时间窗: 4 hour

lung ultrasound findings

lung ultrasound at 2 hour

时间窗: 2 hour

lung ultrasound findings

次要结局

未报告次要终点

研究者

发起方
Gozdem Kayki
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Gozdem Kayki

Investigator

Hacettepe University

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