The Impact of Music Medicine on Preterm Brain Development and Behavior
NCT Number: NCT06536296
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Infant Development|Language Development|Prematurity|Stress
Interventions: OTHER: Music|OTHER: Music and parent voice|OTHER: Standard Care
Sponsor: Brigham and Women's Hospital
Collaborators: Yale New Haven Health System Center for Healthcare Solutions
Sex: ALL
Age: CHILD
Enrollment: 243
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
Start Date: 2024-09-01
Completion Date: 2030-03-01
Locations: Yale New Haven Hospital, New Haven, Connecticut, 06510, United States|Brigham and Women's Hospital, Boston, Massachusetts, 02115, United States

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.

Primary Outcome Measures: Bayley-4 language performance (SA3 primary outcome), Study patients Language performance measured on the Bayley-4 at 2 years corrected age, 2 years corrected age|Amygdala volume on MRI (SA1a, primary outcome), Amygdala volume as a proxy of cumulative stress measured on term-equivalent brain MRI, At term-equivalent (~ 3 months of age), 37-41 weeks postmenstrual age (PMA)|Intranetwork connectivity in Salience and Language networks (SA2a, primary outcome), We will measure the intranetwork connectivity in Salience and Language networks in infants exposed to music and music with parent voice compared those in SC arm at term-equivalent, Term-equivalent (~ 3 months of age), 37-41 weeks postmenstrual age (PMA)
Secondary Outcome Measures: Infant physiology - oxygen saturation, We will record infant physiologic vital signs (i.e. oxygen saturation) from infants' bedside monitor around each study intervention, From enrollment to term-equivalent 37-41 weeks PMA|Infant physiology - respiratory rate, We will record infant physiologic vital signs (i.e. respiratory rate) from infants' bedside monitor around each study intervention, From enrollment to term-equivalent 37-41 weeks PMA|Infant physiology - heart Rate, We will record infant physiologic vital signs (i.e. heart rate) from infants' bedside monitor around each study intervention, From enrollment to term-equivalent 37-41 weeks PMA|Telomere length, Assess infant premature aging at term-equivalent by measurement of telomere length on blood samples, At enrollment and term-equivalent 37-41 weeks PMA|Neurodevelopmental assessment - cognitive outcomes, Study patients' cognitive performance measured on the Bayley-4 assessment at 2 years corrected age, 2 years corrected age|Neurodevelopmental assessment - motor outcomes, Study patients' motor performance measured on the Bayley-4 assessment at 2 years corrected age, 2 years corrected age|Neurodevelopmental assessment - child behavior outcomes, Study patients' behavioral performance measured on the Child Behavior Checklist at 2 years corrected age, 2 years corrected age|Brain development, Brain development and injury classified using the established Kidokoro scoring system applied to term-equivalent brain MRI, Term-equivalent age - 37-41 weeks PMA|Parent stress, Assessment of parent stress (Parental Stressor Scale) using a standardized survey of families of study infants, From term-equivalent age to 2 years corrected age|Parent anxiety and depression, Assessment of parent anxiety and depression (Hospital Anxiety and Depression Scale) using one standardized survey that provides a combined score, From term-equivalent age to 2 years corrected age|Infant Neurobehavior, We will assess infant neurobehavior using the Hammersmith Neonatal Neurological Examination at term-equivalent age 37-41 weeks PMA, Term-equivalent 37-41 weeks PMA