RecruitingNot ApplicableNCT06536296

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"


Sponsor

Brigham and Women's Hospital

Enrollment

243 participants

Start Date

May 19, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 24 WeeksMax Age: 30 Weeks

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Music, Music and parent voice, and others for people with infant development, language development, and other related conditions. The study is currently recruiting participants at 2 locations. People eligible for this study include aged 24 Weeks to 30 Weeks.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERMusic

Arm 1: Music only

OTHERMusic and parent voice

Arm 2: Music and parent voice

OTHERStandard Care

Standard Care


Locations(2)

Yale New Haven Hospital

New Haven, Connecticut, United States

Brigham and Women's Hospital

Boston, Massachusetts, United States

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NCT06536296


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