Cortical Pain Processing in Full Term Infants, After Giving Different Non-pharmacological Analgesia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 主要终点
- Cortical oxy-haemoglobin increase
研究概览
简要总结
Minor painful procedures are frequently performed on newborn infants and non-pharmacological analgesia is commonly used. As more than one analgesic method may be applied simultaneously in clinical practice, the relative contribution and efficacy of analgesic components still needs to be further elucidated. In the present study neonatal cortical brain response during four types of non-pharmacological analgesia (oral glucose, expressed breastmilk, maternal holding plus oral glucose, maternal holding plus breastfeeding) will be studied. The aim is to assess the differential effect of oral solutions (glucose, breastmilk), when given alone or in combination with maternal relationship (holding, breastfeeding). The study will test the hypothesis that the mother-infant relationship would improve the analgesic effect of oral solutions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 3 Days 至 3 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Full term healthy infants, needing a heel-prick for metabolic screening;
- •Informed consent obtained from parents.
排除标准
- •Presence of sedation or analgesia (other than non pharmacological analgesia given during the experimental procedure)
研究组 & 干预措施
Oral glucose solution + maternal holding
Infants will receive 2 mL of oral glucose solution two minutes before the heel-prick and will be held in the mothers' lap (maternal relationship) throughout the painful procedure.
干预措施: Oral glucose solution + maternal holding (Other)
Breastfeeding
Infants will be breastfed two minutes before the heel-prick and throughout the painful procedure.
干预措施: Breastfeeding (Other)
Oral glucose solution
Infants will receive 2 mL of oral glucose solution given two minutes before the heel-prick on a changing table.
干预措施: Oral glucose solution (Other)
Oral expressed breastmilk
Infants will receive 2 mL of expressed breastmilk given two minutes before the heel-prick on a changing table.
干预措施: Oral expressed breastmilk (Other)
结局指标
主要结局
Cortical oxy-haemoglobin increase
时间窗: During the procedure
Multichannel near-infrared spectroscopy will be used to estimate cerebral cortex activation by measuring increase in cortical oxy-haemoglobin (HbO2)
次要结局
- Neonatal Infant Pain Scale (NIPS)(During the procedure)