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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 5 months
Maximum Age: 7 months
Healthy Volunteers: f
View:

• 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

Locations
United States
Connecticut
Yale New Haven Hospital
NOT_YET_RECRUITING
New Haven
Massachusetts
Brigham and Women's Hospital
RECRUITING
Boston
Contact Information
Primary
Carmina Erdei, MD
cerdei@bwh.harvard.edu
6174620202
Backup
Yvonne Sheldon, RN, MS
ysheldon@bwh.harvard.edu
6177327954
Time Frame
Start Date: 2025-05-19
Estimated Completion Date: 2031-03-01
Participants
Target number of participants: 243
Treatments
Experimental: Music
We will create three recordings with increasing complexity for each infant. For each infant developmental stage (32, 34, 36+ weeks PMA), Music Therapists (MTs) in both units will present parents with a curated list of 8-10 musically comparable, familiar lullabies to select from. Songs will be available in different languages reflective of patient diversity, with rhythm, tempo, pitch range/ change, instrumentation, melody, harmony selected drawing on available evidence, including BWH NICU pilot data. Timing: MBI to be administered after regular NICU care and feeding times, which are typically considered stressful times for infants. The goal of the intervention will be to provide a calming and relaxing experience to the infant as they settle back to sleep after handling times. Music delivery will occur via infant-adapted headphones to facilitate blinding.
Experimental: Music and parent voice
The selected lullabies will be pre-recorded by the MT as described above to include a guitar accompaniment track, and a separate vocal track with the MT singing along, in two separate keys to allow variation for parent voice range and comfort. Parents will be invited to sing along with the recorded track of MT singing, and MT will later remove the MT-voice recording track so only the parent voice will be heard with the guitar in the final recording. Timing: MBI to be administered after regular NICU care and feeding times, which are typically considered stressful times for infants. The goal of the intervention will be to provide a calming and relaxing experience to the infant as they settle back to sleep after handling times. Music delivery will occur via infant-adapted headphones to facilitate blinding.
Active_comparator: Reference/ Standard of care
These are infants recruited in the study who will receive the unit standard of care. They will be listening to the NICU ambient noise via infant-adapted headphones but will not receive any music intervention.
Related Therapeutic Areas
Sponsors
Leads: Brigham and Women's Hospital
Collaborators: Yale New Haven Health System Center for Healthcare Solutions

This content was sourced from clinicaltrials.gov