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临床试验/NCT06827197
NCT06827197已完成不适用

Role of Interleukin-1β and Prostaglandin E2 in Prediction and Outcome of Apnea in Neonates

Benha University2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2023年5月1日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
2
主要终点
Duration of NICU stay

研究概览

简要总结

Our thesis proposed that IL-1β may affect brainstem respiratory control via prostaglandin-dependant mechanism so we investigated the mediator roles of IL-1β and PGE2 levels in predicting apnea in pretertm newborn and their relation to clinical outcomes.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
1 Day 至 2 Months(Child)
性别
All
接受健康志愿者

入选标准

  • Preterm infants born at less than 37 weeks of gestation.
  • Neonates aged from birth up to 28 days.
  • Neonates diagnosed with apnea of prematurity or exhibiting apneic episodes

排除标准

  • Full-term neonates.
  • Neonates with major congenital malformations or genetic syndromes.
  • Neonates with severe neurological impairments (e.g., intraventricular hemorrhage grade III or IV).
  • Neonates with confirmed or suspected sepsis or active infections.
  • Neonates receiving steroids, nonsteroidal anti-inflammatory drugs (NSAIDs), or other medications known to alter interleukin-1β or prostaglandin E2 levels.
  • Neonates with congenital heart diseases.
  • Neonates with a history of significant birth asphyxia requiring extensive resuscitation.
  • Neonates whose parents or guardians refuse to provide informed consent.

结局指标

主要结局

Duration of NICU stay

时间窗: 1 month

Mortality rate

时间窗: 1 month

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

Amany Mohammed El-Rebigi, MD

Lecturer of Pediatrics, Faculty of Medicine, Benha University, Benha, Egypt

Benha University

研究点 (2)

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