2-Brain Regulation to Achieve Improved Neuroprotection During Early Development

NCT06659809 | Recruiting

• 1 other identifier: 2-BRAINED
• Study Type: interventional
• Target: 159
• Locations: 1 country
• Sites: 2

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 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

Keywords

preterm birth; EEG; hyperscanning; video-feedback; early intervention; brain-to-brain co-regulation

Outcome Measures

Primary Outcomes (3)

• Phase-Locking Value (PLV)

  EEG index of brain-to-brain co-regulation among PT and FT parent-infant dyads

  9 months (infant's corrected age)

• Amplitude-Amplitude Coupling (AAC)

  EEG index of brain-to-brain co-regulation among PT and FT parent-infant dyads

  9 months (infant's corrected age)

• Imaginary Coherence (ICoh)

  EEG index of brain-to-brain co-regulation among PT and FT parent-infant dyads

  9 months (infant's corrected age)

Secondary Outcomes (17)

• Parental NICU-related stress

  NICU discharge T1 (only VPT)

• Sensory profile

  3 months (infant's corrected age) T2

• Sensory profile

  6 months (infant's corrected age) T3

• Sensory profile

  9 months (infant's corrected age) T4

• Anxiety symptoms

  3 months (infant's corrected age) T2

Study Arms (3)

VPT infants and their caregivers randomly allocated to the intervention arm (VPT-VF)

EXPERIMENTAL

Mother-infant dyads will partecipate in 6 weekly 1-hour sessions of Tele-care video-feedback intervention

Behavioral: Tele-care video-feedback intervention (TVFI)

VPT infants and their caregivers randomly allocated to the care as usual arm (VPT-CU)

NO INTERVENTION

Usual care; no VF intervention. This arm will act as a control group matched to preterm conditions of VPT-VF.

FT infants and their caregivers (FT-CG)

NO INTERVENTION

Usual care; no VF intervention. This arm will act as an additional control group unmatched to preterm conditions.

Interventions

Tele-care video-feedback intervention (TVFI) BEHAVIORAL

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.

VPT infants and their caregivers randomly allocated to the intervention arm (VPT-VF)

Eligibility Criteria

• Age: Up to 3 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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;

You may not qualify if:

• infant's major comorbidities (e.g., genetic syndromes, malformations, brain injuries);
• parental psychiatric diagnoses;

Sponsors & Collaborators

• IRCCS National Neurological Institute "C. Mondino" Foundation: lead
• IRCCS Eugenio Medea: collaborator
• National Research Council, Institute of Clinical Physiology, Italy: collaborator

Study Sites (2)

Scientific Institute IRCCS E. Medea

Bosisio Parini, Italy

RECRUITING

CNR Pisa

Pisa, Italy

ACTIVE NOT RECRUITING

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Central Study Contacts

Livio Provenzi, PhD

CONTACT

0382380287; livio.provenzi@mondino.it

Serena Grumi, PhD

CONTACT

0382380287; serena.grumi@mondino.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2024
• First Posted: October 26, 2024
• Study Start: April 24, 2023
• Primary Completion: December 24, 2025
• Study Completion: April 24, 2026
• Last Updated: October 26, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP
• Time Frame: After study completion
• Access Criteria: Researchers will be able to access the raw data and the supporting information through the Zenodo repository upon request and after sharing an analysis plan

Locations

IT (2)