Improving neuroprotection for premature infants through video feedback
2-Brain Regulation to Achieve Improved Neuroprotection During Early Development (2- BRAINED)
NA · IRCCS National Neurological Institute "C. Mondino" Foundation · NCT06659809
This study is testing if a video feedback program can help improve the bonding and brain development of very preterm infants and their mothers after they leave the NICU.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 159 (estimated) |
| Ages | N/A to 3 Months |
| Sex | All |
| Sponsor | IRCCS National Neurological Institute "C. Mondino" Foundation (other) |
| Locations | 2 sites (Bosisio Parini and 1 other locations) |
| Trial ID | NCT06659809 on ClinicalTrials.gov |
What this trial studies
This project focuses on very preterm (VPT) infants who are at risk for neurodevelopmental issues due to stressors experienced during their stay in the Neonatal Intensive Care Unit (NICU). It aims to compare brain-to-brain co-regulation between full-term and VPT infants interacting with their mothers using electroencephalographic (EEG) hyperscanning. Additionally, the study investigates the effects of an early post-discharge video-feedback intervention designed to enhance parent-infant bonding and promote better developmental outcomes. The trial is randomized and includes multiple intervention arms to assess the efficacy of the video-feedback approach.
Who should consider this trial
Good fit: Ideal candidates include infants aged between birth and 3 months who were born very preterm and whose parents are proficient in Italian.
Not a fit: Patients with major comorbidities or parental psychiatric diagnoses may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly enhance neurodevelopmental outcomes for premature infants and improve parental well-being.
How similar studies have performed: Other studies have shown promise in using video-feedback interventions for enhancing parent-infant interactions, but this specific application with EEG hyperscanning in VPT dyads is novel.
Eligibility criteria
Show full inclusion / exclusion 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;
Where this trial is running
Bosisio Parini and 1 other locations
- Scientific Institute IRCCS E. Medea — Bosisio Parini, Italy (RECRUITING)
- CNR Pisa — Pisa, Italy (ACTIVE_NOT_RECRUITING)
Study contacts
- Study coordinator: Livio Provenzi, PhD
- Email: livio.provenzi@mondino.it
- Phone: 0382380287
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Premature Birth, preterm birth, EEG, hyperscanning, video-feedback, early intervention, brain-to-brain co-regulation