Assessment of Autonomic Nervous System Regulatory Mechanisms During Postnatal Period in Newborns
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Autonomic (parasympathetic) reactivity in response to non-pharmacological pain relief in newborns
研究概览
简要总结
The project aims to assess the regulatory mechanisms of autonomic nervous system using noninvasive methods in newborns during postnatal adaptation period. Evaluated parameters will include complex analysis of electrodermal activity as a parameter reflecting sympathetic cholinergic system and indices of heart rate variability reflecting the activity of parasympathetic cardiac regulation. The project is focused on the neuro-psycho-physiological characteristics of physiological adaptation in early postnatal age and the effect of non-pharmacological pain relieving.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Hour 至 4 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •healthy term newborns
- •physiological postnatal adaptation
- •signed parental informed consent
排除标准
- •preterm delivery
- •impaired postnatal adaptation
- •perinatal infection
- •congenital diseases and genetic anomalies
- •hypoglycemia
- •hyperbilirubinemia requiring phototherapy treatment
结局指标
主要结局
Autonomic (parasympathetic) reactivity in response to non-pharmacological pain relief in newborns
时间窗: within the first 4 days of postnatal life - during and after pain stimulus
The study of autonomic nervous system complex regulatory mechanisms included in the reactivity - test: stress stimulus (painful intervention) with non-pharmacological pain relieving and recovery phase using HRV quantitative and qualitative analysis. 1st group (control group, n=25) without pain relief; 2nd group (n=25) with oral application of sucrose during nociception stimulus; 3rd group (n=25) with oral application of mother milk during nociceptive stimulus.
Characteristics of parasympathetic (vagal) heart regulation in newborns in relation to nociception
时间窗: within the first 4 days of postnatal life
The study of cardiac vagal regulation of heart rate in relation to nociceptive stimulus using conventional linear and novel nonlinear analysis of heart rate variability (HRV) by special software (Kubios HRV, University of Eastern Finland, Kuopio, Finland). Continual recordings of RR intervals will be recorded using Polar V800 (Polar, Finland). HRV indices: linear (time domain - mean square of successive differences (MSSD); spectral domain - low frequency power (LF), high frequency power (HF), total spectral power (TP); non-linear (symbolic dynamics - 0V%, 2LV%, entropy).
Characteristics of sympathetic activity in newborns in relation to nociception
时间窗: within the first 4 days of postnatal life
The study of sympathetic cholinergic system indexed by electrodermal activity (EDA) using linear and novel nonlinear parameters characterizing complex sympathetic behavior in relation to nociceptive stimulus. Continual EDA recording associated with peripheral temperature monitoring will be performed using device BioInfinity, Thought Technology Ltd., Canada. EDA indices: linear - SCA (skin conductance amplitude), frequency of NS-EDR (nonspecific electrodermal responses), nonlinear - SIE (symbolic information entropy), and ApEn (approximate entropy).
Pain quality assessment in newborns: Neonatal Facial Coding System (NFCS) scaling system
时间窗: within the first 4 days of postnatal life - during pain stimulus
Assessment of the pain quality during painful intervention in newborns associated with muscular application of K vitamin after birth and heel lancing (blood spot) on 3rd postnatal day (standard neonatal care) according to Neonatal Facial Coding System (NFCS). NFCS: visual monitoring of newborn's face during pain stimulus for the presence of 9 specific facial actions: brow bulge, eye squeeze, naso - labial furrow, open lips, stretch mouth (horizontal/vertical), lip purse, taut tongue, chin quiver. Scale range: 0 - 9 points; (0 = no pain; 9 = maximal pain presentation).
Autonomic (sympathetic) reactivity in response to non-pharmacological pain relief in newborns
时间窗: within the first 4 days of postnatal life - during and after pain stimulus
The study of autonomic nervous system complex regulatory mechanisms included in the reactivity - test: stress stimulus (painful intervention) with non-pharmacological pain relieving and recovery phase using EDA quantitative and qualitative analysis. 1st group (control group, n=25) without pain relief; 2nd group (n=25) with oral application of sucrose during nociception stimulus; 3rd group (n=25) with oral application of mother milk during nociceptive stimulus.
次要结局
- Developmental aspect of parasympathetic regulatory mechanisms in early postnatal period(early after birth; 24 hours of life; 3rd - 4th day of life)
- Developmental aspect of sympathetic regulatory mechanisms in early postnatal period(early after birth; 24 hours of life; 3rd - 4th day of life)
- Maternal clinical parameters effect on the neonatal autonomic (sympathetic) nervous system regulation(prior to delivery + retrospective data)
- Delivery mode effect on autonomic (sympathetic) nervous system regulation(at the time of delivery)
- Delivery mode effect on autonomic (parasympathetic) nervous system regulation(at the time of delivery)
- Selected laboratory parameters in relation to autonomic (parasympathetic) nervous system regulation(immediately after birth + on 3rd - 4th postnatal day)
- Blood pressure in relation to autonomic (sympathetic) nervous system regulation(within the first 4 days of postnatal life)
- Blood oxygen saturation in relation to autonomic (sympathetic) nervous system regulation(within the first 4 days of postnatal life)
- Acid - base parameters in relation to autonomic (parasympathetic) nervous system regulation(immediately after birth + on 3rd - 4th postnatal day)
- Maternal clinical parameters effect on the neonatal autonomic (parasympathetic) nervous system regulation(prior to delivery + retrospective data)
- Selected laboratory parameters in relation to autonomic (sympathetic) nervous system regulation(immediately after birth + on 3rd - 4th postnatal day)
- Acid - base parameters in relation to autonomic (sympathetic) nervous system regulation(immediately after birth + on 3rd - 4th postnatal day)
- Role of psychosocial factors in autonomic (sympathetic) nervous system regulation(immediately after birth + within the first 4 days of postnatal life)
- Role of psychosocial factors in autonomic (parasympathetic) nervous system regulation(immediately after birth + within the first 4 days of postnatal life)
- Blood pressure in relation to autonomic (parasympathetic) nervous system regulation(within the first 4 days of postnatal life)
- Blood oxygen saturation in relation to autonomic (parasympathetic) nervous system regulation(within the first 4 days of postnatal life)
- Role of umbilical cord clamping in autonomic (sympathetic) nervous system regulation(at the time of delivery)
- Role of umbilical cord clamping in autonomic (parasympathetic) nervous system regulation(at the time of delivery)