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Recruiting
NCT06536296
The Impact of Music Medicine on Preterm Brain Development and Behavior
Conditions: Infant Development, Language Development, Prematurity, Stress
Sex: All
Ages: 24 Weeks – 30 Weeks
Healthy volunteers: No
Phase: NA
Enrollment: 243
Sponsor: Brigham and Women's Hospital
Location: Yale New Haven Hospital New Haven Connecticut
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.
Source: ClinicalTrials.gov (NCT06536296). StuddyBuddy aggregates publicly available trial information.