Amphia Premature Infant Pain Study; Breast Milk vs Sucrose
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 75
- 试验地点
- 2
- 主要终点
- Pain scores assessed by the PIPP score
研究概览
简要总结
Last thirty years, many research was performed concerning pain in the newborn. These investigations showed us the negative effects of pain in the neonatal period. Our research concerns the choice of analgesics for the premature newborn during a heel lance. Newborns with a gestational age of 32-37 weeks are randomly assigned over three groups. They can receive breastfeeding, during the heel lance, a bottle with supplemental breast milk or sucrose.
The primary objective of the Amphia Premature Infant Pain study, is to investigate whether there is a difference in PIPP-scores in premature newborns who undergo a heel lance, receiving breast milk or sucrose. Our hypothesis is that the PIPP-score will be lower in newborns receiving breast milk compared to sucrose. And the investigators presume that breast feeding has the same analgesic effect as giving supplemental breast milk.
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
- None
入排标准
- 年龄范围
- 1 Day 至 2 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •born at a gestational age between 32+0 and 36+6 weeks,
- •being nourished with breast milk
- •the necessity for a clinical blood sample.
排除标准
- •perinatal asphyxia,
- •birth trauma,
- •condition of cardio-respiratory instability,
- •condition of serious nutritional problems with clinical evidence of gastro oesophageal reflux disease,
- •drug abuse of the mother
- •and application of sedative medication to mother or child.
研究组 & 干预措施
sucrose
In the third group, newborns receive sucrose 1ml 24% two minutes before procedure, followed by non-nutritive sucking. During the procedure the newborn lies in his cot.
干预措施: sucrose (Other)
supplemental breast milk
In group two, the newborns receive supplemental breast milk, lying in the arms of a nurse during the heel lance.
干预措施: supplemental breast milk (Other)
Breast feeding
Newborns who are assigned to group one, receive breastfeeding during the blood sample and thereby have skin-skin contact between mother and child.
干预措施: breast feeding (Other)
结局指标
主要结局
Pain scores assessed by the PIPP score
时间窗: The PIPP score will be assessed during a heellance. This heellance will be performed after one day of life and before two months.
The primary outcome in this trial is the PIPP-score.The PIPP-score is a multidimensional pain assessment measure developed in 1995 . The PIPP-score is validated for procedural and post-operative pain in premature and term newborns.
次要结局
- Pain score assessed by the COMFORTneo score(The COMFORTneo score will be assessed during a heellance. This heellance will be performed after one day of life and before two months.)
- partial correlation between the two pain assessment tools.(up to 2 years)
- intra-class correlation coefficient(up to 2 years)
研究者
R.H.T. van Beek
dr. R.H.T. van Beek, Amphia Hospital, pediatric department
Amphia Hospital