Assessment of Autonomic Co-regulation Between Newborn and Parent During Kangaroo Care Sessions in Neonatal Intensive Care Units
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- change form baseline high frequency index (HFnu) of variability RR short-term heart rate (HRV) in the frequency domain, from the parent and the child at 1 hour
研究概览
简要总结
Mother-infant separation, as a result of hospitalization, leads to stress and anxiety for both parent and infant, lowers feelings of maternal competency and corrupts bonding process.
Kangaroo Care (KC), is as a widespread procedure in which the naked newborn is placed on the parent's bare chest. KC is known to enhance neonatal outcome by improving temperature regulation, cardiorespiratory stability or psychomotor development. It also promotes mother-infant interactions and enhances parental psychological well-being.
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. This one can be assess by a new monitor called NIPΣ (Neonatal index of parasympathetic activity) in newborns and ANI (Analgesic nociception index) in adults can provide a comfort index by quantifying the parasympathetic tone.
The investigators hypothesize that kangaroo care could induce an autonomic co-regulation between newborn and parent by increasing parasympathetic activity.
The study will involve 40 preterm or term newborns and their parent, performing a one hour kangaroo care session in intensive unit and neonatal intensive care unit from hospital of Saint-Etienne (France).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- — 至 3 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
newborn is above 28 weeks of gestational age
40 parent-newborn duos in which the newborn is above 28 weeks of gestational age and less than 3 months of life and hospitalized in neonatal intensive care units of our university hospital (Saint-Etienne - France)
干预措施: Evaluation of Autonomic nervous system indices (Device)
结局指标
主要结局
change form baseline high frequency index (HFnu) of variability RR short-term heart rate (HRV) in the frequency domain, from the parent and the child at 1 hour
时间窗: Minutes 0 (early skin to skin), 10, 20, 30, 40, 50 and 60.
Measured during the ECG recording
次要结局
- Evaluation of the NIPE index of comfort and discomfort (Mdoloris Medical Systems ®) for the newborn(Minutes 0 (early skin to skin), 10, 20, 30, 40, 50 and 60.)
- Ptot (indices of variability of heart rate) for the newborn(Minutes 0 (early skin to skin), 10, 20, 30, 40, 50 and 60.)
- VLF (indices of variability of heart rate) for the newborn(Minutes 0 (early skin to skin), 10, 20, 30, 40, 50 and 60.)
- ratio LF/HF (indices of variability of heart rate) for the newborn(Minutes 0 (early skin to skin), 10, 20, 30, 40, 50 and 60.)
- gestational age(at the inclusion)
- Ptot (indices of variability of heart rate) for the parent(Minutes 0 (early skin to skin), 10, 20, 30, 40, 50 and 60.)
- SDANN (indices of variability of heart rate) for the newborn(Minutes 0 (early skin to skin), 10, 20, 30, 40, 50 and 60.)
- SD1 and SD2 (indices of variability of heart rate) for the newborn(Minutes 0 (early skin to skin), 10, 20, 30, 40, 50 and 60.)
- fractal index (indices of variability of heart rate) for the parent(Minutes 0 (early skin to skin), 10, 20, 30, 40, 50 and 60.)
- Evaluation of the ANI index of comfort and discomfort (Mdoloris Medical Systems ®) for the parent.(Minutes 0 (early skin to skin), 10, 20, 30, 40, 50 and 60.)
- VLF (indices of variability of heart rate) for the parent(Minutes 0 (early skin to skin), 10, 20, 30, 40, 50 and 60.)
- LF (indices of variability of heart rate) for the parent(Minutes 0 (early skin to skin), 10, 20, 30, 40, 50 and 60.)
- HF (indices of variability of heart rate) for the parent(Minutes 0 (early skin to skin), 10, 20, 30, 40, 50 and 60.)
- HF (indices of variability of heart rate) for the newborn(Minutes 0 (early skin to skin), 10, 20, 30, 40, 50 and 60.)
- ratio LF/HF (indices of variability of heart rate) for the parent(Minutes 0 (early skin to skin), 10, 20, 30, 40, 50 and 60.)
- SDNN (indices of variability of heart rate) for the parent(Minutes 0 (early skin to skin), 10, 20, 30, 40, 50 and 60.)
- SDNN (indices of variability of heart rate) for the newborn(Minutes 0 (early skin to skin), 10, 20, 30, 40, 50 and 60.)
- pNN30 and pNN50 (indices of variability of heart rate) for the parent(Minutes 0 (early skin to skin), 10, 20, 30, 40, 50 and 60.)
- pNN30 and pNN50 (indices of variability of heart rate) for the newborn(Minutes 0 (early skin to skin), 10, 20, 30, 40, 50 and 60.)
- LF (indices of variability of heart rate) for the newborn(Minutes 0 (early skin to skin), 10, 20, 30, 40, 50 and 60.)
- SDANN (indices of variability of heart rate) for the parent(Minutes 0 (early skin to skin), 10, 20, 30, 40, 50 and 60.)
- RMSSD (indices of variability of heart rate) for the parent(Minutes 0 (early skin to skin), 10, 20, 30, 40, 50 and 60.)
- RMSSD (indices of variability of heart rate) for the newborn(Minutes 0 (early skin to skin), 10, 20, 30, 40, 50 and 60.)
- SD1 and SD2 (indices of variability of heart rate) for the parent(Minutes 0 (early skin to skin), 10, 20, 30, 40, 50 and 60.)
- Poincaré-plot index (indices of variability of heart rate) for the parent(Minutes 0 (early skin to skin), 10, 20, 30, 40, 50 and 60.)
- Poincaré-plot index (indices of variability of heart rate) for the newborn(Minutes 0 (early skin to skin), 10, 20, 30, 40, 50 and 60.)
- fractal index (indices of variability of heart rate) for the newborn(Minutes 0 (early skin to skin), 10, 20, 30, 40, 50 and 60.)
- entropy index (indices of variability of heart rate) for the parent(Minutes 0 (early skin to skin), 10, 20, 30, 40, 50 and 60.)
- entropy index (indices of variability of heart rate) for the newborn(Minutes 0 (early skin to skin), 10, 20, 30, 40, 50 and 60.)