临床试验/NCT00218946

NCT00218946已完成2 期

Nasogastric Tube in Premature Babies - Pain and Treatment. A Randomised, Partly Blinded, Placebo-controlled Factorial Clinical Trial of Sucrose and Pacifier

Norwegian University of Science and Technology1 个研究点分布在 1 个国家目标入组 24 人开始时间: 2005年1月最近更新: 2015年4月8日

适应症

干预措施

试验速览

阶段: 2 期
状态: 已完成
发起方: Norwegian University of Science and Technology
入组人数: 24
试验地点: 1
主要终点: Pain measured on PIPP (Premature Infant Pain Profile) scale

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Does sucrose or pacifier influence pain in premature babies when a nasogastric tube is inserted?

详细描述

A total of 24 premature babies are randomised to receive either placebo (sterile water), 30 % sucrose, or pacifier in a complete factorial, cross-over design. Pain is rated on the PIPP scale by observers blinded to the procedure other than use of pacifier.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Factorial
盲法: Single (Care Provider)

入排标准

年龄范围: 3 Days 至 8 Weeks（Child）
性别: All
接受健康志愿者: 是

入选标准

•28 - 32 weeks gestational weeks
•not on mechanical ventilation

排除标准

•high risk group regarding cerebral prognosis

研究组 & 干预措施

sucrose and pacifier

Experimental

sucrose, pacifier

干预措施: Sucrose (Drug)

pacifier

Experimental

No fluid, pacifier

干预措施: Pacifier (Device)

water

Experimental

water, no pacifier

干预措施: sterile water (Other)

sucrose

Experimental

Sucrose, no pacifier

干预措施: Sucrose (Drug)

water and pacifier

Experimental

water, pacifier

干预措施: Pacifier (Device)

sucrose and pacifier

Experimental

sucrose, pacifier

干预措施: Pacifier (Device)

结局指标

主要结局

Pain measured on PIPP (Premature Infant Pain Profile) scale

时间窗: 4 week to complete

次要结局

未报告次要终点

研究者

发起方

Norwegian University of Science and Technology

申办方类型

Other

责任方

Sponsor

研究点 (1)

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