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RECRUITING
NCT06536296
NA

The Impact of Music Medicine on Preterm Brain Development and Behavior

Sponsor: Brigham and Women's Hospital

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

24 Weeks - 30 Weeks

Study Type

INTERVENTIONAL

Enrollment

243

Start Date

2025-05-19

Completion Date

2031-03-01

Last Updated

2026-03-25

Healthy Volunteers

No

Interventions

OTHER

Music

Arm 1: Music only

OTHER

Music and parent voice

Arm 2: Music and parent voice

OTHER

Standard Care

Standard Care

Locations (2)

Yale New Haven Hospital

New Haven, Connecticut, United States

Brigham and Women's Hospital

Boston, Massachusetts, United States