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The Impact of Music Medicine on Preterm Brain Development and Behavior

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

Who can join

24 Weeks – 30 Weeks · All sexes

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.

About the study

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.

What is being tested

• Music (other)
• Music and parent voice (other)
• Standard Care (other)

Sponsor: Brigham and Women's Hospital · Participants: 243 · Started: May 19, 2025

Contact the study team

• Carmina Erdei, MD · Phone: 6174620202
• Isabella J Lawandy · Phone: 4014901670

Official record on ClinicalTrials.gov — NCT06536296

Locations in the U.S.

Conditions

• Premature Birth

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.