UnknownNot Applicable

Epigenetics and Protective Factors in the Preterm Infant

Italy94 participantsStarted 2019-01-01

Plain-language 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.

Who can participate

Age range

30 Minutes

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria for PT children are: * 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. Inclusion criteria for FT infants are: * 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. 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

DNA methylation changes in PT

Timeframe: first 6 months (Corrected Age for PT) of infant's life

Trial details

NCT IDNCT04804280

SponsorIRCCS Eugenio Medea

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2024-04-04

Contact for this trial

Rosario Montirosso

+39031877494 rosario.montirosso@lanostrafamiglia.it

View on ClinicalTrials.gov More Preterm Birth trials