Status:
RECRUITING
The Impact of Music Medicine on Preterm Brain Development and Behavior
Lead Sponsor:
Brigham and Women's Hospital
Collaborating Sponsors:
Yale New Haven Health System Center for Healthcare Solutions
Conditions:
Infant Development
Language Development
Eligibility:
All Genders
24-30 years
Phase:
NA
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 s...
Detailed Description
Preterm birth remains the leading cause of death for children under five. For survivors, it also accounts for high morbidity and substantial physical, psychosocial, emotional, and financial burden for...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 19 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2031
Estimated Enrollment :
243 Patients enrolled
Trial Details
Trial ID
NCT06536296
Start Date
May 19 2025
End Date
March 1 2031
Last Update
June 15 2025
Active Locations (2)
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1
Yale New Haven Hospital
New Haven, Connecticut, United States, 06510
2
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115