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临床试验/NCT00396838
NCT00396838已完成不适用

Cardiac Autonomic Reactivity and Behavioral Response to Pain in Full-Term Neonates

Rambam Health Care Campus1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2006年11月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
300
试验地点
1

研究概览

简要总结

Background: Heel lancing is a routine procedure for the diagnosis of phenylketonuria in infants. Despite the short- and long-term adverse effects of pain, there are no guidelines for the reduction of such pain. Previous studies evaluated different treatment modalities; however, in most of them, pain response was assessed by subjective measures.

Aims of study: 1. To characterize the pain response of infants by using a computerized analysis of the ECG. 2. To compare six different methods of pain reduction during heel lancing in newborns.

Methods: The time, geometric and frequency domains of the infants' ECG will be computed during heel lancing. 150 healthy full-term infants will be evaluated in six treatment groups: breastfeeding, bottle feeding, skin-to-skin contact, lying on a table without anything, lying with a pacifier and lying while getting a glucose solution. The differences in pain response to these six treatment modalities will be assessed and compared to the infants' length of cry, and scoring of the infants' behavioral response.

研究设计

研究类型
Observational
时间视角
Prospective

入排标准

年龄范围
48 Hours 至 72 Hours(Child)
性别
All
接受健康志愿者

入选标准

  • normal full-term newborns (>38 weeks)
  • Apgar score >=8 at five minutes after delivery.

排除标准

  • congenital anomalies
  • medical complications
  • need for oxygen administration

研究者

申办方类型
Other

研究点 (1)

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