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2-Brain Regulation to Achieve Improved Neuroprotection During Early Development

NCT06659809 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 159

Last updated 2024-10-26

No results posted yet for this study

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 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

  • Premature Birth

Interventions

BEHAVIORAL

Tele-care video-feedback intervention (TVFI)

The TVFI 6 weekly sessions are organized in two subsequent phases: 4 sharing the focus sessions and 2 integration sessions. Sharing the focus sessions are dedicated to the discussion between the psychologist and the mother of specific themes related to parenting and parent-infant interaction: physical stimulation, responsiveness, teaching, and parenting experience. The goal of the sharing the focus sessions is to develop insights about the infants' behavioral signals, the best ways to provide stimulations and get in touch, strategies to promote emotion regulation, and to sustain cognitive and behavioral achievements. In the subsequent two integration sessions, the mother plays with the infant while the psychologist provides guidance based on topics previously discussed during the first four sessions. The goal is to promote a pragmatical translation of the insights developed during the sharing the focus sessions into the interactive exchanges between the mother and the infant.

Sponsors & Collaborators

  • IRCCS Eugenio Medea

    collaborator OTHER

  • National Research Council, Institute of Clinical Physiology, Italy

    collaborator OTHER

  • IRCCS National Neurological Institute "C. Mondino" Foundation

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Max Age
3 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-04-24
Primary Completion
2025-12-24
Completion
2026-04-24

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06659809 on ClinicalTrials.gov