跳至主要内容
临床试验/NCT07821632
NCT07821632尚未招募不适用

Predictors of Prolonged Mechanical Ventilation in Preterm Infants Admitted to Neonatal Intensive Care Unit of Assiut University Children Hospital

Assiut University0 个研究点目标入组 100 人开始时间: 2026年9月10日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
100
主要终点
Occurrence of prolonged mechanical ventilation

研究概览

简要总结

This prospective cohort study aims to identify the independent predictors of prolonged mechanical ventilation in preterm infants admitted to the Neonatal Intensive Care Unit of Assiut University Children Hospital.

详细描述

Prolonged mechanical ventilation in preterm infants is associated with increased morbidity including bronchopulmonary dysplasia and neurodevelopmental impairment. This prospective observational study will include preterm infants (born before 37 completed weeks) who require invasive mechanical ventilation.

Infants will be classified into two groups according to the duration of invasive mechanical ventilation: prolonged (>7 days or frequent reintubation) and non-prolonged (≤7 days). clinical, perinatal, and laboratory predictors of prolonged mechanical ventilation will be evaluated.

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 36 Weeks(Child)
性别
All
接受健康志愿者

入选标准

  • - Preterm infants born before 37 completed weeks of gestation
  • Admission to the NICU within the neonatal period
  • Requirement for invasive mechanical ventilation
  • Written informed consent from parents or legal guardians

排除标准

  • - Infants born after 37 weeks of gestation
  • Major congenital anomalies
  • Chromosomal abnormalities
  • Congenital neuromuscular disorders
  • Cyanotic congenital heart disease

研究组 & 干预措施

Prolonged Mechanical Ventilation

Preterm infants who require invasive mechanical ventilation for more than 7 days or frequent reintubation

Non-Prolonged Mechanical Ventilation

Preterm infants who require invasive mechanical ventilation for ≤7 days.

结局指标

主要结局

Occurrence of prolonged mechanical ventilation

时间窗: Up to 30 days

Proportion of preterm infants who require invasive mechanical ventilation for more than 7 days or frequent reintubation.

次要结局

  • In-hospital mortality(Up to 30 days)
  • Duration of invasive mechanical ventilation(Up to 30 days)
  • Successful extubation rate(Up to 30 days)
  • Incidence of bronchopulmonary dysplasia(Up to 30 days)
  • Incidence of neonatal sepsis(Up to 30 days)
  • Duration of NICU stay(Up to 30 days)

研究者

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

Demiana Youssef Zakaria Ghaly

Resident Physician

Assiut University

相似试验