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临床试验/NCT04393064
NCT04393064Unknown不适用

Fiberoptic Endoscopic Evaluation of Swallowing(FEES) in Infants Graduated From (NICU) Neonatal Intensive Care Unite

Cairo University1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2017年12月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
150
试验地点
1
主要终点
Fiberoptic endoscopic evaluation of swallowing (FEES)

研究概览

简要总结

Based on study showing the ability of using FEES in infant in NICU; so the aim of this study to screen the newborns graduated from NICU using clinical bed side evaluation as well as flexible endoscopic assessment of swallowing to identify the ones suffering from oropharyngeal and / or esophageal dysphagia as well as newborns at risk for aspiration &aspiration pneumonia to tailor or identify appropriate feeding plan for those high risk popularities and support them

详细描述

  • Population study& disease condition Newborns that are discharged from NICU and are hemodynamically stable.
  • Interventions The following study will be conducted in neonatal intensive care unit of Kasr alany and Abu EI-Rish hospital, also conducted in Phoniatrics Outpatient of Kasr alany, Cairo university This study will recruit 75 preterm and 75 fullterm will be recruited in this study; all will be hemodynamically stable on discharge

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
1 Day 至 6 Months(Child)
性别
All
接受健康志愿者

入选标准

  • Neonates who discharged from NICU as they are hemodynamic stable

排除标准

  • Neonates with congenital anomalies that interfere with the introduction or the procedure of FEES as nasal deformities, choanal atresia, cleft lip and cleft palate.
  • Neonates have liver disease and/ or bleeding tendency

结局指标

主要结局

Fiberoptic endoscopic evaluation of swallowing (FEES)

时间窗: baseline

to identify the ones suffering from oropharyngeal and / or esophageal dysphagia as well as newborns at risk for aspiration \&aspiration pneumonia by FEES to tailor or identify appropriate feeding plan for those high risk popularities and support them

次要结局

  • Other imaging procedures including X-ray (Chest & abdominal) , U/S(ultrasound) , CT(computer tomography) & ECHO(Echocardiography)(baseline)

研究者

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

Lamiaa Mohamed Abdel Motaleb

Neonatal specialist

Cairo University

研究点 (1)

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