Breastfeeding Versus Saccharose for Prevention of the Procedural Pain in the Newborn
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 114
- 试验地点
- 2
- 主要终点
- Increase of the total concentration of haemoglobin
研究概览
简要总结
The aim of this study is to compare the impact of two non-medicinal strategies: the breast-feeding and saccharose to measure effects in cerebral cortex during pain using near infrared spectroscopy (NIRS)
详细描述
Many studies of non-medicinal treatments(saccharose and breast-feeding)show a decrease of expression of pain in newborn. However Slater and al questioned these practices due to the absence of modification of the cerebral answer measured by evoked potential.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 37 Weeks 至 42 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Gestationnel age included between 37 and 42 weeks
- •Born in the CHRU of Brest
- •Breast-Fed
- •Score of Apgar upper to 7
- •No pathology malformative
- •Absence of known chromosomal abnormality
- •Consent of parents
排除标准
- •Maternal drug use
- •Morphinic treatment
- •Barbiturate treatment
- •Benzodiazépine treatment
结局指标
主要结局
Increase of the total concentration of haemoglobin
时间窗: Measure two minutes before painful gesture, at the moment of painful gesture and 2 minutes after painful gesture. The newborn will be followed for the duration of hospital stay, an expected average of 30 to 60 minutes
Increase of the total concentration of haemoglobin (delta HbT) measured by the spectrometer during the intravenous injection.
次要结局
- Dosage of rate salivary cortisol(before and after painful gesture)