Ignite Creation Date:
2024-05-06 @ 5:17 PM
Last Modification Date:
2024-10-26 @ 2:25 PM
Study NCT ID:
NCT05253924
Status:
RECRUITING
Last Update Posted:
2023-10-18
First Post:
2022-02-01
Brief Title:
Biological Underpinnings of Socio-emotional Regulation in Preterm Infants and Healthy Controls
Sponsor:
IRCCS Eugenio Medea
Organization:
IRCCS Eugenio Medea
Study Overview
Official Title:
Biological Underpinnings of Socio-emotional Regulation in Preterm Infants and Healthy Controls Insights From EEG and Epigenetic Data
Status:
RECRUITING
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 ie 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 ie frontal alpha asymmetry remains unexplored The investigators therefore expect to find associations between increased methylation levels of socio-emotional and stress related genes ie SLC6A4 NR3C1 OXTR Piezo1 Piezo2 TRPV1 and TRPM8 with spontaneous oscillations of neural activity at frontal sites measured by EEG ie frontal alpha asymmetry Finally there is ample evidence that infants 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 ie the ability to perceive the physiological condition of ones body in this way and to represent ones 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 genesie SLC6A4 NR3C1 OXTR Piezo1 Piezo2 TRPV1 and TRPM8 associated with social-emotional regulation
3 the contribution of mothers 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 caregivers ability to understand and respond to the infants 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
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 genesie SLC6A4 NR3C1 OXTR Piezo1 Piezo2 TRPV1 and TRPM8 associated with social-emotional regulation
3 the contribution of mothers 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 caregivers ability to understand and respond to the infants 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None