Status:
RECRUITING
2-Brain Regulation to Achieve Improved Neuroprotection During Early Development
Lead Sponsor:
IRCCS National Neurological Institute "C. Mondino" Foundation
Collaborating Sponsors:
IRCCS Eugenio Medea
National Research Council, Institute of Clinical Physiology, Italy
Conditions:
Premature Birth
Eligibility:
All Genders
Up to 3 years
Phase:
NA
Brief Summary
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...
Detailed Description
Very preterm (VPT) birth is a major risk condition for child neurological and behavioral development and as well as for parental well-being, mainly due to multiple sources of stress (e.g., separation ...
Eligibility Criteria
Inclusion Criteria:
- infants' (corrected) age between birth and 3 months;
- parental age greater than 18 years;
- parental mastery of Italian language;
- parents living together with the infant;
Exclusion Criteria:
- infant's major comorbidities (e.g., genetic syndromes, malformations, brain injuries);
- parental psychiatric diagnoses;
Key Trial Info
Start Date :
April 24 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 24 2026
Estimated Enrollment :
159 Patients enrolled
Trial Details
Trial ID
NCT06659809
Start Date
April 24 2023
End Date
April 24 2026
Last Update
October 26 2024
Active Locations (2)
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1
Scientific Institute IRCCS E. Medea
Bosisio Parini, Italy
2
CNR Pisa
Pisa, Italy