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
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.
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 individuals, families, and communities. The impairments span over multiple domains, with language difficulties affecting about half of surviving children. Evidence indicates that preterm birth has significant impacts on long-term functioning, yet primary prevention of preterm birth is presently not feasible. It is therefore imperative to prioritize early interventions to mitigate these adverse lo…
Eligibility
- Age range
- 0–0 years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- OtherMusic
Arm 1: Music only
- OtherMusic and parent voice
Arm 2: Music and parent voice
- OtherStandard Care
Standard Care
Locations (2)
- Yale New Haven HospitalNew Haven, Connecticut
- Brigham and Women's HospitalBoston, Massachusetts