Autonomic Nervous System Reactivity of the Newborn After a Nociceptive Stress: Interest of Sucrose and Non-nutritive Sucking : A Controlled Randomized Single-center Study.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- High frequency normalized index (HFnu)
研究概览
简要总结
The management of the pain is a constant care concern in neonatal and maternity units. Many studies show an interest in the use of sugar solutions to reduce nociception during painful events in infants. However, these studies are based mainly on behavioral observation of the newborn but intrinsic mechanisms of analgesic power are not clearly understood for sucrose solutions.
Our hypothesis is that the analgesic mechanism of sucrose solutions in infants involves a subcortical reactivity notably by action via the brain stem. To explore the intensity of pain and evaluate the subcortical activity, we will use 1) the analysis of heart rate variability (frequency indices whose HFnu) as a peripheral witness of subcortical functioning of the autonomic nervous system 2) electroacoustic analysis of the intensity of crying baby, 3) a composite pain score (DAN score).
详细描述
The investigators want to show that the short term autonomic nervous system (ANS) response, after a nociceptive action in the new-born in maternity depends on whether it is preceded by non-nutritive sucking and / or sucrose administration.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- — 至 8 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy Newborn in maternity unit of the Saint-Etienne University Hospital (France), to receive venipuncture for blood tests or neonatal screening test
- •Establishing consent form signed by the holder of parental authority
排除标准
- •Children suffering from a disease affecting the central nervous system.
- •Children treated with paracetamol oral solution (if cephalohematoma for example) or other analgesics (nalbuphine) or sedative, at the time of registration.
- •Newborns impregnated with a prepartum maternal analgesia.
研究组 & 干预措施
Glucose sucking
The newborn will receive one minute before the painful care either a compress with sucrose.
The puncture made in the veins of the back of the hand, will be performed only once per patient per test.
Glucose 30% by oral route (1 ml).
干预措施: Glucose sucking (Drug)
Water sucking
The newborn will receive one minute before the painful care either a compress with water.
The puncture made in the veins of the back of the hand, will be performed only once per patient per test.
Sterile water by oral route (1 ml).
干预措施: Water sucking (Drug)
No sucking
The puncture made in the veins of the back of the hand, will be performed only once per patient per test.
干预措施: No sucking (Other)
结局指标
主要结局
High frequency normalized index (HFnu)
时间窗: From 15 min before the painful care to 15 min after.
It is a reflect of the RR short term heart rate variability (HRV) in the frequency domain. It is measured with a ECG Holter monitor.
次要结局
- Low frequency (LF and LFnu),(From 15 min before the painful care to 15 min after.)
- Scale of hetero-assessment of pain (DAN)(15 minutes after the painful care)
- The time domain (SDNN, SDANN, pNN50).(From 15 min before the painful care to 15 min after.)
- LF / HF ratio(From 15 min before the painful care to 15 min after.)
- Electro acoustical characteristic of crying newborn : Duration(From 15 min before the painful care to 15 min after.)
- Frequency domain(From 15 min before the painful care to 15 min after.)
- Electro acoustical characteristic of crying newborn : Frequency(From 15 min before the painful care to 15 min after.)
- Electro acoustical characteristic of crying newborn : Frequency variations(From 15 min before the painful care to 15 min after.)