The Impact of Music Medicine on Preterm Brain Development and Behavior
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age24-30
SponsorBrigham and Women's Hospital
About this trial
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
Qualifiers
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
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Music
- Music and parent voice
- Standard Care
Treatment groups
243 Participants
are divided into 3 treatment groupsSponsors and collaborators
Brigham and Women's Hospital
Lead sponsor
Yale New Haven Health System Center for Healthcare Solutions
Collaborator
Source ClinicalTrials.gov