The Impact of Music Medicine on Preterm Brain Development and Behavior - A Two-Center Randomized Controlled Trial The Lullaby Study

What this Trial Is About

Researchers are conducting a two-site randomized controlled trial to study the effects of music, with or without a parent's voice, on very preterm infants. The study aims to understand how these auditory interventions impact acute and long-term stress, brain connectivity seen on MRI at term-equivalent age, and language and other developmental outcomes at two years corrected age. The research is motivated by the need to improve outcomes for very preterm infants who face significant risks from early birth and the challenging sensory environment of the neonatal intensive care unit (NICU). The study involves three groups: one receiving music only, one receiving music combined with a parent's voice, and a control group receiving standard care with ambient NICU sounds. Music therapists select lullabies tailored to the infant's developmental stage and cultural background, which are delivered through infant-adapted headphones after stressful care or feeding times to promote calming. Parents in the music and parent voice group sing along with recordings to include their voice in the intervention. The control group listens to usual NICU sounds without added music. Participants will be closely monitored from enrollment through term-equivalent age, including brain MRIs at around 37 to 41 weeks postmenstrual age, and assessments of stress markers and neurodevelopment up to two years corrected age. Researchers will measure language skills using the Bayley-4 scale, amygdala brain volume, brain network connectivity, infant physiology, telomere length, and parent stress and mental health. This comprehensive approach aims to provide evidence on how music-based interventions might support brain development and behavior in very preterm infants.

The Impact of Music Medicine on Preterm Brain Development and Behavior