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临床试验/NCT02552927
NCT02552927已完成不适用

Effect of Chest Shielding on the Incidence of Patent Ductus Arteriosus in Premature Infants Undergoing Phototherapy

University of Rochester2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2015年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
2
主要终点
Incidence of symptomatic Patent ductus arteriosus

研究概览

简要总结

This is a feasibility study where Infants will be randomized to either chest shielding with aluminum foil or chest shielding without aluminum foil while undergoing phototherapy for premature infants. The primary outcome is patent ductus arteriosus.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
23 Weeks 至 33 Weeks(Child)
性别
All
接受健康志愿者

入选标准

  • less or equal to 29 weeks or 1000g at birth
  • Admitted to the NICU (Neonatal intensive care unit) within 24 hours after birth
  • English speaking parents

排除标准

  • Congenital abnormalities
  • Chromosomal disorders
  • Cyanotic heart defects
  • Nitric oxide
  • Prophylactic phototherapy
  • Unlikely to survive beyond 72 hours according to the attending neonatologist
  • Do not require phototherapy

结局指标

主要结局

Incidence of symptomatic Patent ductus arteriosus

时间窗: During first 2 weeks

次要结局

  • Urinary Nitric oxide level(During first 2 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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