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临床试验/NCT05383586
NCT05383586招募中不适用

Inter-personal Brain Coupling Between Preterm Infants, Their Parents and a Musician During Creative Music Therapy Using Functional Near-infrared Imaging (fNIRI) Hyperscanning

University of Zurich2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2022年11月3日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
20
试验地点
2
主要终点
Inter-personal synchronization of cerebral oxygenation and hemoglobin concentration

研究概览

简要总结

Inter-personal brain coupling between preterm infants, their parents and a musician during Creative Music Therapy using functional near-infrared imaging (fNIRI) hyperscanning and systemic physiology measurements

详细描述

Background Preterm infants represent a growing population in health care. Unfortunately, many infants suffer from neurodevelopmental impairments that persist into adolescence and adulthood. Besides other risk factors, auditory deprivation (e.g., the lack of exposure to regular intrauterine rhythms of the maternal heartbeat and the maternal voice), and the overwhelming stressful auditory environment of an intensive care unit may negatively impact brain maturation. Studies showed that infant-parent separation can impede the bidirectional development of physical, emotional, and psychological bonds between parents and their infants. Brain development is linked to nurturing social contact and early auditory experience, as demonstrated by human and animal studies. New studies showed, music is promoting neurobiological processes and neuronal learning in the human brain, which starts before birth.

Rationale Creative Music Therapy (CMT) provides meaningful interactions and a nurturing enrichment of the auditory environment by infant-directed singing in lullaby-style. Positive short-term music therapy outcomes (i.e., arousal, behavior, respiratory rate, maternal anxiety) have been shown in several reviews. Preliminary results of a recent pilot feasibility randomized controlled trial (RCT) suggest that functional brain connectivity as measured by resting-state functional magnet resonance imaging seems to have a possible early beneficial effect of CMT which manifests in (1) lower thalamo-cortical processing delay, (2) stronger functional networks, and (3) higher functional integration in predominantly left prefrontal, supplementary motor and inferior temporal brain regions. Depressive symptoms may be decreased and physical connectedness increased between infants and their parents with CMT. However, real time evaluation of CMT's possible immediate effect on the brain activity in infants and inter-personal synchronization processes between parents and infants have not been conducted yet.

The primary objective is to explore if CMT:

Improves inter-personal interaction between the infant, the parent (i.e. the mother or father) and the music therapist assessed via cerebral oxygenation synchronization between the infant and parent as well as the infant and the music therapist in the left auditory cortex and frontal cortex.

The secondary objectives are to explore if CMT:

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

盲法说明

The intervention can not be masked since it is provided with live music to the infants and parents.

入排标准

年龄范围
32 Weeks 至 36 Weeks(Child)
性别
All
接受健康志愿者

入选标准

  • Clinically stable preterm infants (no invasive cardiovascular or ventilation support)
  • age: 7-21 days of life
  • born with 32 0/7 ≤ 36 6/7 weeks of gestation
  • mentally stable parents of the included infants

排除标准

  • admission for palliative care
  • congenital malformation
  • parental psychiatric disorders
  • parental language barriers

结局指标

主要结局

Inter-personal synchronization of cerebral oxygenation and hemoglobin concentration

时间窗: 50 minutes

Inter-personal synchronization (determined by the time-dependent coherence calculated via Wavelet transform coherence) of cerebral oxygenation (StO2 in %) and total hemoglobin concentration (\[tHb\] in relative µM) time-series in the brain between the infant and the parent as well as the infant and the music therapist measured by functional near-infrared spectroscopy (fNIRS) neuroimaging with a commercially available device approves for clinical applications (OxyPrem) in the left auditory and prefrontal cortex. Both devices provide similar measurements of cerebral oxygenation and hemodynamics, i.e. relative changes in the concentration of oxyhemoglobin (\[O2Hb\] in relative µM) and deoxyhemoglobin (\[HHb\] in relative µM). These time-series will be first pre-processed (removal of artifacts, band-pass filtered (0.01-0.5 Hz)) and then analyzed (Wavelet coherence and subsequent statistical analysis via a generalized additive model and Bayesian analysis).

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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