Exploring the effects of skin-to-skin contact on brain responses in preterm infants
Skin-to-skin Contact in NICU, Caregiving Touch and Neural Correlates of Slow Stroking Touch Stimulation in Preterm Infants. A MRI Study
This study looks at how skin-to-skin contact and gentle touch can affect the brain development of preterm babies in the NICU.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 6 Weeks to 10 Weeks |
| Sex | All |
| Sponsor | IRCCS Eugenio Medea Academic / other |
| Locations | 1 site (Bosisio Parini, Lecco) |
| Trial ID | NCT04293939 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the impact of skin-to-skin contact (SSC) and caregiving touch on the brain development of preterm infants in the Neonatal Intensive Care Unit (NICU). By utilizing functional Magnetic Resonance Imaging (fMRI), researchers will examine the neural correlates of gentle skin stroking in preterm infants compared to full-term infants. The study aims to understand how the duration of SSC and caregiving touch influences brain connectivity and responses in these vulnerable infants. The findings could provide insights into the importance of physical contact for neurodevelopment in preterm infants.
Who should consider this trial
Good fit: Ideal candidates for this study are preterm infants born at or before 37 weeks of gestation and full-term infants born after 37 weeks.
Not a fit: Patients with perinatal injuries, genetic syndromes, neurological pathologies, or sensory deficits may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of how physical touch influences brain development in preterm infants, potentially leading to improved caregiving practices.
How similar studies have performed: While studies on full-term infants have shown success in understanding the effects of touch on brain development, this specific approach in preterm infants is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Preterm infants (clinical sample) Inclusion Criteria: * Gestational age (GA) \< or = 37 weeks * age-appropriate neurological examination Exclusion Criteria: * presence of perinatal injuries/genetic syndromes * documented neurological pathology * presence of sensory deficits Full-term infants (control sample) Inclusion Criteria: * Gestational age (GA) \> 37 weeks * age-appropriate neurological examination Exclusion Criteria: * presence of perinatal injuries/complications * presence of sensory deficits Inclusion criteria for mothers (preterm and full-term): * Age over 18 years * Good comprehension of Italian language * No documented cognitive/psychiatric impairments * No documented psychotropic medication during pregnancy * No single-parent families
Where this trial is running
Bosisio Parini, Lecco
- Associalzione La Nostra Famiglia - IRCCS Eugenio Medea — Bosisio Parini, Lecco, Italy (Recruiting)
Study contacts
- Study coordinator: Eleonora Mascheroni
- Email: eleonora.mascheroni@lanostrafamiglia.it
- Phone: +39031877464
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.