The Impact of Music Medicine on Preterm Brain Development and Behavior

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
Brigham and Women's Hospital
Study ID
NCT06536296
Status
Recruiting
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Conditions

  • Infant Development
  • Language Development
  • Prematurity
  • Stress

Eligibility Criteria

Sex
ALL
Age
24 Weeks - 30 Weeks
Healthy Volunteers
Not accepted

Interventions

  • Music — OTHER
    Arm 1: Music only
  • Music and parent voice — OTHER
    Arm 2: Music and parent voice
  • Standard Care — OTHER
    Standard Care

Study Details

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.

Key Dates

Start date
May 19, 2025
Status verified
Jun 2025
Primary completion
Aug 30, 2030
Completion
Mar 1, 2031

Study Design

Enrollment
243 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • 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.

Primary Outcome Measure

Bayley-4 language performance (SA3 primary outcome) [ Time Frame: 2 years corrected age ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Yale New Haven HospitalNew HavenConnecticut06510
Christine Henry
[email protected]
Angela Montgomery, MD (PRINCIPAL_INVESTIGATOR)
Brigham and Women's HospitalBostonMassachusetts02115
Elizabeth Singh, MSN
[email protected]
5125165360

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