Actively Recruiting
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
Eligibility Criteria
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
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
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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
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
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