Last reviewed · How we verify
NCT06659809: 2-BRAINED
2-Brain Regulation to Achieve Improved Neuroprotection During Early Development
NA trial testing Tele-care video-feedback intervention (TVFI) in Premature Birth in 159 participants. Currently enrolling.
24 December 2025
Quick facts
| Lead sponsor | IRCCS National Neurological Institute "C. Mondino" Foundation |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | supportive care |
| Enrollment | 159 |
| Start date | 24 April 2023 |
| Primary completion | 24 December 2025 |
| Estimated completion | 24 April 2026 |
| Sites | 2 locations across Italy |
Drugs / interventions tested
- Tele-care video-feedback intervention (TVFI)
Conditions studied
- Premature Birth — all drugs for Premature Birth →
Sponsor
IRCCS National Neurological Institute "C. Mondino" Foundation
Who can join
Under 3 Months, any sex, with Premature Birth. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06659809
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Premature Birth
Currently open trials in the same condition.
- NCT07490912 — Neonatal Data and Biobank to Study Factors Influencing Development in Preterm Infants Born at <32 Weeks' Gestation and/o · recruiting
- NCT07183462 — Azithromycin and Ampicillin for Late PPROM · Phase 4 · recruiting
- NCT07306793 — The Effect of PIOMI and Chronobiological Nutrition on Readiness for Feeding, Full Transition to Oral Feeding and Body We · NA · recruiting
- NCT06554522 — Pragmatic Evaluation of Respiratory Distress Syndrome Treatment in Africa · Phase 4 · recruiting
- NCT06340971 — Air Pollution and Pregnancy · recruiting
Other IRCCS National Neurological Institute "C. Mondino" Foundation trials
Trials by the same sponsor.
- NCT06820411 — A Pilot Study to Assess Optimal Prevention and Outcome Improvement in Young Ischemic Stroke · NA · active not recruiting
- NCT06983119 — Case-Finding for Neurocognitive Disorders in Pavia · NA · recruiting
- NCT06453863 — Effects of Biofeedback Footwear in Parkinson's Disease: Assessment of Functional Motor Abilities and Locomotion · NA · not yet recruiting
- NCT06715436 — Multiple Sclerosis and the Effects of Ketogenic Diet Therapy · NA · recruiting
- NCT07442916 — Non-Invasive Brain Stimulation as Add-on Treatment in Chronic Migraine With Medication Overuse · NA · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06659809 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by IRCCS National Neurological Institute "C. Mondino" Foundation
- Last refreshed: 26 October 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06659809.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing