NCT06536296 The Impact of Music Medicine on Preterm Brain Development and Behavior
| NCT ID | NCT06536296 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Brigham and Women's Hospital |
| Condition | Infant Development |
| Study Type | INTERVENTIONAL |
| Enrollment | 243 participants |
| Start Date | 2025-05-19 |
| Primary Completion | 2030-08-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 243 participants in total. It began in 2025-05-19 with a primary completion date of 2030-08-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The investigators are conducting a two-site randomized control trial with the aim of defining the impact of music (M) without or with parent voice (MPV) on very preterm infants' acute and cumulative stress, intranetwork connectivity on term brain MRI, and language and other neurodevelopmental outcomes at two years corrected age. This is based on the hypothesis that infants in MPV arm are expected to experience the greatest benefit compared with infants receiving standard care.
Eligibility Criteria
Inclusion Criteria: * Very preterm infants born between 24+0 and 30+6 weeks' gestational age (GA) from 2 level III NICUs (Brigham and Women's Hospital, Boston, MA and Yale New Haven, CT) * Infants who are medically stable per the clinical care team Exclusion Criteria: * Infants with major genetic or congenital anomalies known to be associated with developmental delay * Infants with severe brain injury (such as intraparenchymal hemorrhage, severe white matter injury) * Infants who are severely ill infants for whom MBI is not feasible * Infants of parents who cannot complete questionnaires in English or Spanish.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06536296 clinical trial?
This trial is open to participants of all sexes, aged 24 Weeks or older, up to 30 Weeks, studying Infant Development. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06536296 currently recruiting?
Yes, NCT06536296 is actively recruiting participants. Contact the research team at cerdei@bwh.harvard.edu for enrollment information.
Where is the NCT06536296 trial being conducted?
This trial is being conducted at New Haven, United States, Boston, United States.
Who is sponsoring the NCT06536296 clinical trial?
NCT06536296 is sponsored by Brigham and Women's Hospital. The trial plans to enroll 243 participants.