Epigenetics and Protective Factors in the Preterm Infant: Neural and Methylation Correlates of Developmental Care During Neonatal Intensive Care Unit Hospitalization

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test, Genetic
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Maximum Age: Newborn
Healthy Volunteers: t
View:

• gestational age: 26+0 to 31+6 weeks;

• absence of documented neurological pathology;

• absence of sensory deficits;

• absence of malformative syndromes and/or major malformations.

• gestational age ≥ 37weeks;

• birth weight ≥ 2,500g;

• APGAR 5' ≥ 7 - delivery without any complications for the child and/or mother;

• no pre/postnatal/postnatal clinical conditions;

• no hospitalizations at the time of birth or postpartum;

• absence of malformative syndromes and/or major malformations.

• 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.

Locations
Other Locations
Italy
Associalzione La Nostra Famiglia - IRCCS Eugenio Medea
RECRUITING
Bosisio Parini
Contact Information
Primary
Rosario Montirosso
rosario.montirosso@lanostrafamiglia.it
+39031877494
Time Frame
Start Date: 2019-01-01
Estimated Completion Date: 2024-09-04
Participants
Target number of participants: 94
Treatments
Preterm children (PT)
* gestational age at birth: 26+0 to 31+6 weeks;~* absence of documented neurological pathology;~* absence of sensory deficits;~* absence of malformative syndromes and/or major malformations.
Full-term children (FT)
* gestational age at birth ≥ 37 weeks;~* birth weight ≥ 2,500g;~* APGAR 5' ≥ 7~* delivery without any complications for baby and/or mother;~* no prenatal and/or postnatal clinical conditions;~* no hospitalizations at the time of birth or postpartum;~* absence of malformative syndromes and/or major malformations.
Related Therapeutic Areas
Sponsors
Leads: IRCCS Eugenio Medea

This content was sourced from clinicaltrials.gov