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临床试验/NCT05253924
NCT05253924招募中不适用

Biological Underpinnings of Socio-emotional Regulation in Preterm Infants and Healthy Controls: Insights From EEG and Epigenetic Data

IRCCS Eugenio Medea1 个研究点 分布在 1 个国家目标入组 76 人开始时间: 2021年7月13日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
76
试验地点
1
主要终点
Negative emotionality assessed during the Still-Face Paradigm (FFSF).

研究概览

简要总结

Preterm infants (PT) often need to spend their first weeks of life in the Neonatal Intensive Care Unit (NICU) where they are exposed to several adverse conditions. Whereas a consistent number of studies suggest that NICU-related experiences may have effects on infant development including long-term impairments in emotional regulation, the underlying mechanisms remain partially unexplored. Spectral analysis of EEG signal has demonstrated that frontal alpha-band asymmetry represents a reliable biomarker of social-emotional functioning. In the literature, higher right frontal activation has been associated with worse emotional regulation but no study has measured this value during a condition of social-emotional stress such as the Still Face paradigm. Our hypothesis is that higher alpha activity will be recorded in right frontal areas in premature infants compared to healthy controls and that this activation will be associated with higher negative emotionality (i.e., worse socio-emotional regulation) expressed during the Still Face paradigm. Moreover, despite several changes in epigenetic patterns have already been reported in association with prematurity and early adverse experiences, the relationship between epigenetic changes and electroencephalographic patterns (i.e. frontal alpha asymmetry) remains unexplored. The investigators therefore expect to find associations between increased methylation levels of socio-emotional and stress related genes (i.e. SLC6A4, NR3C1, OXTR, Piezo1, Piezo2, TRPV1 and TRPM8) with spontaneous oscillations of neural activity at frontal sites measured by EEG (i.e. frontal alpha asymmetry). Finally, there is ample evidence that infant's socio-emotional regulation abilities are highly dependent on the behaviors of their caregivers. More recent studies have shown that behavior can be influenced by interoceptive awareness, i.e., the ability to perceive the physiological condition of one's body in this way and to represent one's internal states. Better interoceptive awareness is associated with better recognition of others' needs, more empathetic behaviors, and better emotional regulation. Therefore, with the present exploratory study, the investigators will compare the interceptive awareness of mothers of preterm infants with that of mothers of full-term infants by exploring possible associations of this dimension with the socio-emotional responses of preterm infants and healthy controls. The investigators expect that better socio-emotional regulation of infants is predicted by a higher level of interoceptive awareness in mothers, regardless of prematurity condition.

详细描述

The main objective of the present study is to:

  1. explore frontal and parietal alpha EEG signal asymmetry in association with social-emotional regulation in a group of preterm infants aged 6-12 months (age corrected, CA).

Secondary aims are: 2. the investigation of epigenetic correlates (methylation of target genes:(i.e. SLC6A4, NR3C1, OXTR, Piezo1, Piezo2, TRPV1 and TRPM8) associated with social-emotional regulation 3. the contribution of mother's interoceptive awareness (Heartbeat Counting Task index) in social-emotional regulation in a sample of premature infants aged 6-12 months (CA).

The study involves the following procedures:

  • EEG signal recording and analysis (frontal alpha rhythm asymmetry; FAA) in PT and FT infants
  • Video recording of mother-child interaction in accordance with a modified version of the Still Face paradigm.
  • Collection of biological material (DNA)
  • Assessment of mothers' interoceptive awareness via Heartbeat Counting Task

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
6 Months 至 1 Year(Child)
性别
All
接受健康志愿者

入选标准

  • Inclusion criteria for PT infants are:
  • gestational age< 37weeks;
  • Inclusion criteria for FT infants are:
  • gestational age ≥ 37weeks;
  • Inclusion criteria for mothers are:
  • mothers of Italian nationality;
  • mother over 18 years of age;
  • mother with absence of manifest psychiatric and/or cognitive pathologies (must be previously diagnosed major psychiatric pathologies);
  • non-addicted/no habitual use of psychotropic medications, drugs, alcohol no smoking;
  • non-single-parent families.

排除标准

  • refer to inclusion criteria

结局指标

主要结局

Negative emotionality assessed during the Still-Face Paradigm (FFSF).

时间窗: Once, From 6 to 12 months (CA for prematurity) of infant's life

Negative emotionality (withdrawn, protesting, complaining, being fussy or crying behaviors) will be assessed using the validated coding system Infant and Caregiver Engagement Phases - ICEP. Coders have to detect the presence or the absence of negative emotionality-related behaviors for each episode of FFSF. Then, a proportion index of negative emotionality will be obtained for each of the five episodes of FFSF dividing the total score of negative emotionality displayed in every FFSF episode for the actual length of the episode, resulting in five negative emotionality indexes. Higher indexes of negative emotionality are indicative of worse social emotional regulation.

Frontal Alpha Asymmetry (FAA)

时间窗: Once, From 6 to 12 months (CA for prematurity) of infant's life

Frontal Alpha Asymmetry (FAA) will be assessed by computing the difference in signal power in the alpha band recorded by two homologous electrodes (or electrode clusters) (i.e. right alpha - left alpha). The EEG signal will be recorded through the medical system eego mylab (AntNeuro), using special headphones equipped with 32 electrodes and suitable to acquire the EEG signal since early childhood. Frontal Alpha Asymmetry (FAA) will also be correlated with Negative emotionality indexes.

次要结局

  • DNA methylation level of target genes(Once, From 6 to 12 months (CA for prematurity) of infant's life)
  • Heartbeat Counting Task index(Once, From 6 to 12 months (CA for prematurity) of infant's life)

研究者

发起方
IRCCS Eugenio Medea
申办方类型
Other
责任方
Sponsor

研究点 (1)

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