The Impact of Music Medicine on Preterm Brain Development and Behavior
The Impact of Music Medicine on Preterm Brain Development and Behavior - A Two-Center Randomized Controlled Trial "The Lullaby Study"
Brigham and Women's Hospital
243 participants
May 19, 2025
INTERVENTIONAL
Conditions
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
Inclusion Criteria2
- 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 Criteria4
- 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.
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Interventions
Arm 1: Music only
Arm 2: Music and parent voice
Standard Care
Locations(2)
View Full Details on ClinicalTrials.gov
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NCT06536296