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Music Medicine for Preterm Brain Development and Behavior

This study is looking at how music, with or without a parent's voice, might help very premature babies (born between 24 and 30 weeks of pregnancy) with their brain development and behavior. Researchers want to see if these music interventions can reduce stress and improve brain connections and language skills. They will compare babies who receive music, music with parent's voice, or standard care. The study aims to enroll 243 babies born at Brigham and Women's Hospital or Yale New Haven. Success will be measured by language performance at 2 years corrected age, and brain changes seen on MRI scans around the time they would have been born (term-equivalent age). The current status of this study is unclear.

Study design
This is an interventional study planning to enroll 243 participants. It compares three groups: music only, music and parent voice, and standard care.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed until 2 years corrected age to assess language performance.

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NCT06536296

The Impact of Music Medicine on Preterm Brain Development and Behavior

Recruiting
NAAges 24–30InterventionalPrevention
Brigham and Women's Hospital
~243 participants
Updated 2026-03-25 on ClinicalTrials.gov
What's tested:MusicMusic and parent voiceStandard Care

At a glance

Recruiting sites
1 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Bayley-4 language performance (SA3 primary outcome)
Measured over 2 years corrected age
+2 more outcomes measured

Conditions

Infant Development
Language Development
Prematurity
Stress

Explore related trials

Preterm Birth

Where it's being run

2 sites across 2 states
Connecticut1
Massachusetts1

Who to contact

Carmina Erdei, MD
[email protected]
6174620202
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Bayley-4 language performance (SA3 primary outcome)2 years corrected age

    Study patients Language performance measured on the Bayley-4 at 2 years corrected age

  • Amygdala volume on MRI (SA1a, primary outcome)At term-equivalent (~ 3 months of age), 37-41 weeks postmenstrual age (PMA)

    Amygdala volume as a proxy of cumulative stress measured on term-equivalent brain MRI

  • Intranetwork connectivity in Salience and Language networks (SA2a, primary outcome)Term-equivalent (~ 3 months of age), 37-41 weeks postmenstrual age (PMA)

    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