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临床试验/NCT06880016
NCT06880016招募中不适用

Evaluation of Serial Lung Ultrasound Data After Surfactant Treatments Applied With Different Methods in Preterm Babies

Konya City Hospital1 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2024年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
68
试验地点
1
主要终点
Evaluation of serial lung ultrasound data after surfactant treatments

研究概览

简要总结

This study aims to investigate the relationship between the method of surfactant administration and improvements in serial lung ultrasound findings in preterm infants requiring surfactant therapy.

详细描述

In the neonatal intensive care unit, lung ultrasound was first used for the diagnosis of neonatal respiratory distress syndrome (RDS) by Avni et al. in 1990. Following this, lung ultrasound rapidly became widespread in neonatal intensive care units and was seen as a potential alternative to chest X-rays. It is now frequently used in cases of RDS, transient tachypnea of the newborn, pneumonia, and pneumothorax. Lung ultrasound has high specificity, sensitivity, positive predictive value, and negative predictive value. It is performed quickly at the bedside, allowing for rapid diagnosis and timely intervention.

Respiratory distress syndrome is one of the most common causes of morbidity and mortality in preterm infants. It results from a surfactant deficiency in the lungs secondary to preterm birth. Early diagnosis and timely administration of intratracheal surfactant, which is the only definitive treatment, are crucial. The diagnosis has traditionally relied on chest X-rays, but with recent advancements, lung ultrasound has also become a diagnostic tool. In addition to diagnosing RDS, lung ultrasound plays a critical role in its differential diagnosis, severity classification, and management in neonates.

Different methods can be used for the intratracheal administration of surfactant in the treatment of neonatal respiratory distress syndrome. Surfactant can be administered through an endotracheal tube in intubated infants. In non-intubated infants, two commonly accepted and frequently used methods are available. The first method involves intubating the infant, administering intratracheal surfactant, and then extubating them back to nasal respiratory support (ENSURE method). The second method involves delivering surfactant via a thin catheter (5F) directly into the trachea while the infant remains on existing nasal respiratory support, without disconnecting them from it (LISA method). Both of these methods are frequently used in neonatal intensive care units, and multiple studies comparing them indicate no clear superiority of one over the other.

Many studies utilizing lung ultrasound incorporate lung ultrasound scoring systems. The first neonatal lung ultrasound score was defined by Brat et al. Each lung is divided into three regions (upper anterior, lower anterior, and lateral), and each region is assigned a score from 0 to 3:

0 points: Defined by the presence of only A-lines.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
1 Day 至 5 Days(Child)
性别
All
接受健康志愿者
否

入选标准

  • •Infants of families who agree to participate in the study
  • •Preterm infants born before 32 weeks of gestation requiring surfactant therapy due to an RDS diagnosis.

排除标准

  • •Infants whose families did not provide consent
  • •Infants with a syndromic appearance or congenital heart disease
  • •Preterm infants born after 32 weeks of gestation

研究组 & 干预措施

Ensure group

Experimental

The first method involves intubating the infant, administering intratracheal surfactant, and then extubating them back to nasal respiratory support (ENSURE method).

干预措施: Evaluation of serial lung ultrasound data after ENSURE surfactant treatments (Diagnostic Test)

Lisa group

Experimental

The second method involves delivering surfactant via a thin catheter (5F) directly into the trachea while the infant remains on existing nasal respiratory support, without disconnecting them from it (LISA method).

干预措施: Evaluation of serial lung ultrasound data after LISA surfactant treatments (Diagnostic Test)

结局指标

主要结局

Evaluation of serial lung ultrasound data after surfactant treatments

时间窗: 6 hours after completion of surfactant administration

This study aims to investigate the relationship between the method of surfactant administration and improvements in serial lung ultrasound findings in preterm infants requiring surfactant therapy.

次要结局

未报告次要终点

研究者

发起方
Konya City Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Melek Buyukeren

Associate Professor

Konya City Hospital

研究点 (1)

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