Epigenetics and Protective Factors in the Preterm Infant: Neural and Methylation Correlates of Developmental Care During Neonatal Intensive Care Unit Hospitalization
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 94
- Locations
- 1
- Primary Endpoint
- DNA methylation changes in PT
Study Overview
Brief Summary
Preterm infants (PT) spend their first weeks of life in the Neonatal Intensive Care Unit (NICU) where they are exposed to unfavorable conditions with different effects on child development including long-term alterations in epigenetic regulation (DNA methylation). Recent studies document that these epigenetic changes are associated with behavioral modifications, such as altered stress reactivity at 3 months and 4 years. A growing number of studies suggest that protective Developmental Care (DC) procedures (e.g., breastfeeding, skin-to-skin contact (SSC), maternal holding) positively impact neurophysiological and behavioral adaptation of PT with long-term effects. Additionally, a neuro-imaging study reported that parental support in the NICU is associated with improved brain connectivity. While in term (FT) infants, parental interpersonal touch (breastfeeding, affectionate touch) is associated with reduced methylation and activation of specific brain areas associated with affective interpersonal touch, to date no study has investigated whether DC practices and maternal care in NICU (specifically, SSC) buffer methylation and support the brain response to affectionate physical touch in PT. The present study investigates the association between DC procedures in NICU, DNA methylation, and brain responses to affectionate touch, investigated through the use of MRI, at 2 months of age (corrected for prematurity), controlling for: (1) birth status (PT vs FT); (2) the duration of SSC during the NICU stay; (3) parental affectionate touch in the home environment and during mother-child interaction.
Detailed Description
Background: preterm infants (PT) spend their first weeks of life in the Neonatal Intensive Care Unit (NICU) where they are exposed to conditions with different effects on child development including long-term alterations in epigenetic regulation. Recent studies document that these epigenetic changes are associated with behavioral modifications, such as altered stress reactivity at 3 months and 4 years. A growing number of studies suggest that protective Developmental Care (DC) procedures (e.g., breastfeeding, skin-to-skin contact (SSC), maternal containment) positively impact neurophysiological and behavioral adaptation of PTs with long-term effects. Moreover, structural factors of the NICU, such as the organization of the unit space based on Open-Bay rather than Single Family Rooms could impact the child's neurobehavioral development and the parent's well-being. For example, a study on the impact of the Single Family Room shows improved medical and neurobehavioral outcomes for the infant at discharge and increased maternal involvement. However, the Single Family Room literature also reports mixed results with some studies finding increased parent involvement but no effect on child growth and some showing increased parent stress.
Primary aim: to evaluate the methylation status of target genes (e.g., BDNF, SLC6A4, OXTR, NR3C1) in association with exposures to DC practices during NICU hospitalization in PT children, compared with a sample of FT children.
Secondary aim: to investigate the relationship between preterm/term birth, DC practices (PT only), maternal touch in the postnatal period, epigenetic status and brain response to soft/soft stimulation during fMRI, at 2 months of age (corrected for prematurity in PT children), controlling for characteristics of the NICU of provenance (NICU Hospital of Monza: Single Family Room vs NICU Hospital of Lecco: Open-Bay).
Planned Activities:
Methods
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- — to 30 Minutes (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
DNA methylation changes in PT
Time Frame: first 6 months (Corrected Age for PT) of infant's life
Correlation between DNA methylation changes of target genes (BDNF, SLC6A4, OXTR, NR3C1) and the duration of Developmental Care practice that involved proximity and pyisical contact during the NICU stay measured by a specific APP.
Secondary Outcomes
- Insular cortex and somatosensory cortex activation in PT and FT infants(when the infants is 2 months-old (Corrected Age for PT))
- Developmental Care procedures in NICU and insular cortex/somatosensory cortex activation in preterm infants(first 2 months (Corrected Age for PT) of infant's life)