跳至主要内容
临床试验/NCT07322315
NCT07322315招募中不适用

Diagnostic Value of Transcranial Doppler Ultrasound for Evaluating Neonatal Craniocerebral Injuries

Kafrelsheikh University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2026年1月6日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
60
试验地点
1
主要终点
Sensitivity of transcranial Doppler ultrasound

研究概览

简要总结

This study aims to evaluate the diagnostic value of transcranial Doppler ultrasonography (TCD) for evaluating neonatal craniocerebral injuries.

详细描述

A high-risk neonate refers to an infant, irrespective of gestational age or birth weight, who exhibits an elevated likelihood of experiencing health complications or death. Preterm infants, defined as those born alive at a gestational age of less than 37 weeks, have seen increased birth and survival rates due to advancements in medical technology and the widespread establishment of Neonatal Intensive Care Units (NICUs).

Neonatal sepsis is one of the leading causes of morbidity and mortality among term and preterm infants worldwide.

Transcranial Doppler ultrasonography (TCD) is the only noninvasive method that enables reliable evaluation of blood flow in the basal intracerebral vessels, providing physiological information complementary to anatomic imaging. TCD is relatively inexpensive, can be performed at the bedside, and enables monitoring in acute emergency settings and for prolonged periods with high temporal resolution, making it ideal for studying dynamic cerebrovascular responses.

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
— 至 37 Weeks(Child)
性别
All
接受健康志愿者

入选标准

  • Both sexes.
  • High-risk neonates with any of the following:
  • Critically ill neonates.
  • Neonatal sepsis.
  • Neonatal encephalopathy includes hypoxic-ischemic encephalopathy.
  • Respiratory distress.
  • Neonatal seizures.
  • Birth asphyxia.
  • Signs and or symptoms of central nervous system disorders like microcephaly, macrocephaly, hypotonia, unexplained poor feeding,
  • Neonates born out of traumatic/instrumental labor.
  • Suspected metabolic disturbances.
  • Neonates with low APGAR score (<7).
  • Neonates with low birth weight (<2.5 kg).

排除标准

  • Congenital malformations.
  • Genetic metabolic diseases or other severe complications.
  • Severe intrauterine infection.

研究组 & 干预措施

Group A

High-risk neonates with confirmed risk factor.

干预措施: Transcranial Doppler ultrasound (Device)

Group B

Healthy neonates without any identified risk factor, matched to Group A for age and sex.

干预措施: Transcranial Doppler ultrasound (Device)

结局指标

主要结局

Sensitivity of transcranial Doppler ultrasound

时间窗: 6 months post-procedure

The sensitivity of transcranial Doppler ultrasound in diagnosing brain injury will be recorded

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Neamat Mohamed Kamal Omar

Resident of Diagnostic and Intervention Radiology, Faculty of Medicine, Kafr- Elsheikh University

Kafrelsheikh University

研究点 (1)

Loading locations...

相似试验