Exploring how protective care affects preterm infants' development
Epigenetics and Protective Factors in the Preterm Infant: Neural and Methylation Correlates of Developmental Care During Neonatal Intensive Care Unit Hospitalization
This study looks at how caring practices like breastfeeding and skin-to-skin contact can help preterm babies develop better in the NICU compared to full-term babies.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 94 (estimated) |
| Ages | N/A to 30 Minutes |
| Sex | All |
| Sponsor | IRCCS Eugenio Medea Academic / other |
| Locations | 1 site (Bosisio Parini, Lecco) |
| Trial ID | NCT04804280 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the impact of developmental care practices, such as breastfeeding and skin-to-skin contact, on the epigenetic regulation of preterm infants in the Neonatal Intensive Care Unit (NICU). It aims to evaluate the DNA methylation status of specific genes in preterm infants compared to full-term infants, assessing how these practices influence neurophysiological and behavioral outcomes. The study also considers the effects of NICU environment organization on both infant development and parental involvement. By understanding these relationships, the research seeks to identify protective factors that can enhance the long-term health of preterm infants.
Who should consider this trial
Good fit: Ideal candidates include preterm infants born between 26 and 31 weeks gestational age without neurological or sensory deficits.
Not a fit: Patients who are full-term infants or those with significant health complications or malformations may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved developmental care practices that enhance the health and development of preterm infants.
How similar studies have performed: Other studies have shown promising results regarding the benefits of developmental care practices in NICU settings, suggesting that this approach is supported by existing research.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
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.