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The Impact of Music Medicine on Preterm Brain Development and Behavior

NCT06536296 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 243

Last updated 2026-03-25

No results posted yet for this study

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.

Conditions

  • Infant Development
  • Language Development
  • Prematurity
  • Stress

Interventions

OTHER

Music

Arm 1: Music only

OTHER

Music and parent voice

Arm 2: Music and parent voice

OTHER

Standard Care

Standard Care

Sponsors & Collaborators

  • Yale New Haven Health System Center for Healthcare Solutions

    collaborator OTHER

  • Brigham and Women's Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
24 Weeks
Max Age
30 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-19
Primary Completion
2030-08-30
Completion
2031-03-01

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06536296 on ClinicalTrials.gov