Assessment of Autonomic Regulation During the Listening of Mother Heart Beat in Newborns
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- NIPΣ index
研究概览
简要总结
Prematurity birth lead to an early breaking link with the in utero environment. A special attention is brought in the neonatal intensive care units to reduce noise and lighting surrounding aiming to protect the newborn.
During the uterine life fetus benefits previously of several auditory stimulations by the maternal voice, the mother's heartbeat. After birth the auditory environment is dramatically modified.
Aim of this study is to submit to the newborn an audio recording of his mother's heart beat to analyze the comfort, stress and autonomic response. Heart rate variability (HRV) analysis is a non-invasive tool able to consider autonomic nervous system activity. Previous studies have shown that pleasant feelings are associated with an increase of high frequencies variations index (HFnu index) reflecting a prevalence of parasympathetic activity in the sympathetic-parasympathetic balance. This one can be simply assess by a monitor named NIPΣ and can provide a comfort index by quantifying the parasympathetic tone.
详细描述
The study will imply 40 preterm and term newborns hospitalized in neonatal intensive care units of the University Hospital of Saint-Etienne (France).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 4 Days 至 10 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Neonates between 28 and 40 Weeks of Gestational Age (wGA)
- •Hospitalized in the neonatal intensive care units of the university hospital of Saint-Etienne (France)
排除标准
- •Respiratory or hemodynamic instability
- •Uncontrolled sepsis
- •Sedation on going
- •Treatment known to modify the sympathetic or parasympathetic activity of the autonomic nervous system
- •Congenital disease
- •Congenital ear pathology
结局指标
主要结局
NIPΣ index
时间窗: During the acoustic listening
Analyze variations of the activity of the autonomic nervous system (R-R cardiac interval) NIPΣ index (from 0 to 100) obtained from an MDoloris® monitor. The base line is measured one hour before
次要结局
- Root mean square of the successive differences (RMSSD).of RR interval(During the acoustic listening)
- Oxygen saturation (%)(During the acoustic listening)
- NIPΣ index(One hour after the acoustic listening)
- Very Low Frequency (VLF)(One hour after the acoustic listening)
- Proportion of NN50 divided by the total number of NN intervals (pNN50)(One hour after the acoustic listening)
- HFnu (normalized high frequency) index.(One hour after the acoustic listening)
- Total power spectrum (Ptot)(One hour after the acoustic listening)
- High Frequency (HF)(One hour after the acoustic listening)
- Ratio Low Frequency (LF) / High Frequency (HF)(One hour after the acoustic listening)
- Heart rate (bpm)(During the acoustic listening)
- Standard deviation of all NN intervals (SDNN)(One hour after the acoustic listening)
- Low Frequency (LF)(One hour the acoustic listening)