Understanding emotional regulation in preterm infants and healthy controls
Biological Underpinnings of Socio-emotional Regulation in Preterm Infants and Healthy Controls: Insights From EEG and Epigenetic Data
This study looks at how preterm infants handle emotions compared to healthy babies to see what biological factors might affect their emotional development.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 76 (estimated) |
| Ages | 6 Months to 1 Year |
| Sex | All |
| Sponsor | IRCCS Eugenio Medea Academic / other |
| Locations | 1 site (Bosisio Parini, Lecco) |
| Trial ID | NCT05253924 on ClinicalTrials.gov |
What this trial studies
This observational study aims to explore the biological factors influencing socio-emotional regulation in preterm infants aged 6-12 months compared to healthy controls. It will utilize EEG signal recording to analyze frontal alpha asymmetry during social-emotional stress, specifically using the Still Face paradigm. Additionally, the study will investigate epigenetic correlates related to social-emotional regulation and assess mothers' interoceptive awareness. By integrating various biomarkers and observational data, the study seeks to uncover the underlying mechanisms affecting emotional development in preterm infants.
Who should consider this trial
Good fit: Ideal candidates include preterm infants born before 37 weeks of gestation and healthy full-term infants, along with their mothers who meet specific eligibility criteria.
Not a fit: Patients who are single parents or whose mothers have psychiatric or cognitive pathologies may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into improving emotional regulation and developmental care strategies for preterm infants.
How similar studies have performed: While this study explores novel associations, previous research has indicated the importance of EEG patterns in emotional regulation, suggesting potential for success in this innovative approach.
Eligibility criteria
Show full inclusion / exclusion 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 -
Where this trial is running
Bosisio Parini, Lecco
- Associalzione La Nostra Famiglia - IRCCS Eugenio Medea — Bosisio Parini, Lecco, Italy (Recruiting)
Study contacts
- Study coordinator: Rosario Montirosso
- Email: rosario.montirosso@lanostrafamiglia.it
- Phone: +39031877494
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.