Actively Recruiting

Phase Not Applicable
Age: 0 - 3Months
All Genders
Healthy Volunteers
NCT06659809

2-Brain Regulation to Achieve Improved Neuroprotection During Early Development

Led by IRCCS National Neurological Institute "C. Mondino" Foundation · Updated on 2024-10-26

159

Participants Needed

2

Research Sites

156 weeks

Total Duration

On this page

Sponsors

I

IRCCS National Neurological Institute "C. Mondino" Foundation

Lead Sponsor

I

IRCCS Eugenio Medea

Collaborating Sponsor

AI-Summary

What this Trial Is About

Each year 15 million infants are born preterm (PT). Even without severe comorbidities, they are exposed to sensory stress during the Neonatal Intensive Care Unit (NICU) stay and are at greater risk of neurodevelopmental problems compared to full-term (FT) counterparts in the short- and long-term period. Altered biobehavioral interpersonal synchrony patterns are documented in PT parent-infant dyads and might contribute to detrimental outcomes. Electroencephalographic (EEG) hyperscanning provides innovative real-time central biomarkers of brain-to-brain co-regulation; it was never applied to PT mother-infant dyads. Early parenting video-feedback (VF) interventions promote at-risk infants' neurodevelopment, yet action mechanisms are partially unknown. The present longitudinal project aims (a) to compare indexes of brain-to-brain co-regulation between dyads of full-term (FT) and VPT infants interacting with their mothers and (b) to investigate the effect of an early post-discharge VF intervention on the brain-to-brain co-regulation indexes of VPT dyads. This study will establish translational hyperscanning as a new field of innovative research with crucial clinical implications.

CONDITIONS

Official Title

2-Brain Regulation to Achieve Improved Neuroprotection During Early Development

Who Can Participate

Age: 0 - 3Months
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Infant's corrected age between birth and 3 months
  • Parent older than 18 years
  • Parent speaks and understands Italian
  • Parents live together with the infant
Not Eligible

You will not qualify if you...

  • Infant has major health problems such as genetic syndromes, malformations, or brain injuries
  • Parent has a psychiatric diagnosis

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 2 locations

1

Scientific Institute IRCCS E. Medea

Bosisio Parini, Italy

Actively Recruiting

2

CNR Pisa

Pisa, Italy

Active, Not Recruiting

Loading map...

Research Team

L

Livio Provenzi, PhD

CONTACT

S

Serena Grumi, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

3

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here