RECRUITING

The Impact of Music Medicine on Preterm Brain Development and Behavior

Description

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.

Study Overview

Study Details

Study overview

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.

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

The Impact of Music Medicine on Preterm Brain Development and Behavior

Condition
Infant Development
Intervention / Treatment

-

Contacts and Locations

New Haven

Yale New Haven Hospital, New Haven, Connecticut, United States, 06510

Boston

Brigham and Women's Hospital, Boston, Massachusetts, United States, 02115

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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.

Ages Eligible for Study

24 Weeks to 30 Weeks

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Brigham and Women's Hospital,

Study Record Dates

2031-03-01