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Clinical Trials/NCT05253924
NCT05253924
Recruiting
N/A

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

IRCCS Eugenio Medea1 site in 1 country76 target enrollmentJuly 13, 2021

Overview

Phase
N/A
Intervention
Not specified
Conditions
Preterm Birth
Sponsor
IRCCS Eugenio Medea
Enrollment
76
Locations
1
Primary Endpoint
Negative emotionality assessed during the Still-Face Paradigm (FFSF).
Status
Recruiting
Last Updated
2 years ago

Overview

Brief Summary

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.

Detailed Description

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 Significance and innovation: To the best of our knowledge, no study has evaluated the association between (1) EEG signal asymmetry, (2) methylation patterns of candidate genes, (3) mothers' interoceptive awareness (Heartbeat Counting Task index), and socio-emotional regulation in premature infants during the first months of life. The present study will integrate several biomarkers and observational data to better elucidate the role of electroencephalographic activation patterns, epigenetic variations, and mothers' interoceptive awareness in the socio-emotional regulation abilities of infants born prematurely. In addition, a particularly novel aspect of this study is the application of EEG signal recording during the Still Face paradigm. The measurement of the EEG signal during this paradigm could increase our knowledge with respect to the brain mechanisms underlying socio-emotional regulation in premature infants and in healthy control. Moreover, the focus on parental bodily states might provide a new perspective suggesting that enteroceptive awareness may contribute to support caregiver's ability to understand (and respond to) the infant's signals and emotional states. Impact: This study is warranted to provide relevant insights for the biochemical and neurological underpinnings of socio-emotional development in preterm infants and will provide new evidence-base information for improving the quality of supportive interventions for preterm infants and caregivers in and outside the NICU. In addition, the identification of potential electroencephalographic patterns associated with emotional regulation in premature and term infants may prove to be a novel biomarker for the early detection of children at risk for emotional and behavioral problems.

Registry
clinicaltrials.gov
Start Date
July 13, 2021
End Date
July 13, 2024
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
IRCCS Eugenio Medea
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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.

Exclusion Criteria

  • refer to inclusion criteria

Outcomes

Primary Outcomes

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

Time Frame: 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)

Time Frame: 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.

Secondary Outcomes

  • 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)

Study Sites (1)

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