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临床试验/NCT02872415
NCT02872415已完成不适用

Impact of Alternative Blood Glucose Testing Site (Forearm) on Pain Reduction in Preterm Neonates.

Assistance Publique Hopitaux De Marseille2 个研究点 分布在 1 个国家目标入组 81 人开始时间: 2017年5月10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
81
试验地点
2
主要终点
The pain assessment

研究概览

简要总结

Numerous experimental and clinical studies have shown that preterm neonates are particularly sensitive to stress. Preterm neonates routinely undergo painful invasive procedures. Each situation causing pain or discomfort can alter their development and cause short term cardiovascular consequences but also have long-term neurocognitive influences. Repetitive procedural pain can also lead to changes in the pain sensitivity threshold therefore. The most common painful procedures are lancing for blood glucose testing. In adults, infants and term newborns, forearm blood glucose testing has been demonstrated to be less painful than conventional sites (heel, fingers). But data is lacking in preterm neonates.

The primary purpose of this study is to demonstrate a significant reduction in pain response during forearm blood lancing vs conventional sites (fingers, heel) in preterm neonates born up to 32 weeks gestation.

This study is an interventional multicenter (3 centers), randomized, double bind trial with a cross over assignment. 60 premature neonates born between 23 to 32 weeks.

Gestation with a postnatal age less than 72 hours that will undergo at least 3 blood glucose pricks will be included. The different sites will be randomly successively tested.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Diagnostic
盲法
Double (Participant, Investigator)

入排标准

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

入选标准

  • Premature neonates 23 to 32 weeks gestation
  • Infant born with a postnatal age greater than or equal to 3 hours and less or equal to 72 hours
  • Infant born with at least 3 blood glucose testing in less than 72 hours

排除标准

  • Severe congenital anomalies that could alter pain perception or expression
  • Extremities congenital anomaly impeding blood glucose testing on different sites
  • Infants born to mothers known to be receiving opiates
  • Severe haemodynamic disturb
  • Severe neurologic injury
  • Neonate with opioids or sedatives medications
  • No parental consent

结局指标

主要结局

The pain assessment

时间窗: 12 months

Painful response using Premature Infant Pain Profile (PIPP)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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