Music and parental voice to support brain and language development in very preterm infants
The Impact of Music Medicine on Preterm Brain Development and Behavior - A Two-Center Randomized Controlled Trial "The Lullaby Study"
NA · Brigham and Women's Hospital · NCT06536296
This project tests whether playing music alone or music with a parent's voice in the NICU can reduce stress and support brain and language development in very preterm infants.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 243 (estimated) |
| Ages | 24 Weeks to 30 Weeks |
| Sex | All |
| Sponsor | Brigham and Women's Hospital (other) |
| Locations | 2 sites (New Haven, Connecticut and 1 other locations) |
| Trial ID | NCT06536296 on ClinicalTrials.gov |
What this trial studies
This is a two-site randomized, controlled trial randomizing very preterm infants to receive music alone, music plus parent voice, or standard care while in the NICU. The team will measure acute and cumulative stress, brain intranetwork connectivity on term-equivalent MRI, and neurodevelopmental outcomes including language at two years corrected age. Infants born between 24+0 and 30+6 weeks' gestation who are medically stable at two level III NICUs are eligible, with parent questionnaires in English or Spanish. The trial compares immediate physiological and imaging markers with longer-term developmental outcomes to see if the interventions confer durable benefits.
Who should consider this trial
Good fit: Ideal candidates are medically stable very preterm infants born at 24+0 to 30+6 weeks' gestation cared for in the participating NICUs whose parents can complete forms in English or Spanish.
Not a fit: Infants with major genetic or congenital anomalies, severe brain injury, those who are too medically unstable for the intervention, or infants cared for outside the participating centers are unlikely to benefit from enrollment.
Why it matters
Potential benefit: If successful, the intervention could lower NICU-related stress and improve brain connectivity and later language and developmental outcomes for very preterm infants.
How similar studies have performed: Smaller randomized and observational NICU studies of music-based interventions have reported reduced stress and short-term neurobehavioral benefits, but large multisite RCT evidence—especially using parent voice—is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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 English or Spanish.
Where this trial is running
New Haven, Connecticut and 1 other locations
- Yale New Haven Hospital — New Haven, Connecticut, United States (NOT_YET_RECRUITING)
- Brigham and Women's Hospital — Boston, Massachusetts, United States (RECRUITING)
Study contacts
- Study coordinator: Carmina Erdei, MD
- Email: cerdei@bwh.harvard.edu
- Phone: 6174620202
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Infant Development, Language Development, Prematurity, Stress, Preterm, Neurodevelopment, Music-based Intervention