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临床试验/NCT01561547
NCT01561547已完成3 期

Maternal Analgesia for Procedural Pain in Preterm Neonates: Does It Remain Efficacious?

IWK Health Centre2 个研究点 分布在 1 个国家目标入组 242 人开始时间: 2012年6月最近更新:
适应症

试验速览

阶段
3 期
状态
已完成
入组人数
242
试验地点
2
主要终点
Premature Infant Pain Profile (PIPP)

研究概览

简要总结

Mothers can provide pain relief to their newborns, even in the context of intensive neonatal care. There is a recent accumulation of data, being analyzed by ourselves in a Cochrane review, that mothers holding their infants in a bare-chested skin-to-skin position, known as Kangaroo Mother Care (KMC), is effective in diminishing pain response during a single painful procedure. While evidence is compelling, leading to recommendations for its use, to date there is not a single study on the repeated efficacy to reduce pain. Current guidelines recommend sweet taste for minor painful procedures. Although there is some controversy about its continued use in this population based on one study with negative neurodevelopmental outcomes as well as its potential interaction with dopaminergic development, oral sucrose (sweet taste) remains efficacious in decreasing pain response over several weeks. The combination of KMC and sucrose is marginally more potent, but again, long term use remains unstudied.

AIMS. To test the repeated efficacy in diminishing pain from heel lance of KMC compared to usual care (sucrose), and of KMC in combination with sucrose by examining each condition at least three times during NICU stay. A secondary aim is to compare these interventions on neurodevelopment at discharge from the NICU.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Investigator, Outcomes Assessor)

入排标准

性别
All
接受健康志愿者

入选标准

  • less than 36.0 weeks gestational age
  • mother is generally available to provide kangaroo mother care

排除标准

  • narcotic analgesics
  • surgery in past 48 hrs
  • major congenital anomalies

结局指标

主要结局

Premature Infant Pain Profile (PIPP)

时间窗: At the moment of painful procedure

The PIPP is a composite measure of procedural pain and is based on changes from baseline in maximum heart rate and minimum oxygen saturation, and the duration of three facial actions. Data are analyzed in 30 second blocks from the moment the painful procedure begins. Time to return to baseline will also be noted. Scoring is done by assessors blind to the purpose of the study and group assignment.

次要结局

  • Neurobehavioral Assessment of Preterm Infants (NAPI)(32, 36 and 40 weeks gestational age)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Celeste Johnston

Principal Investigator

IWK Health Centre

研究点 (2)

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