RECRUITING

The Impact of Music Medicine on Preterm Brain Development and Behavior

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2025-05-19
Study Completion:2031-03-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06536296

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.

Ages Eligible for Study:24 Weeks to 30 Weeks
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * 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)
  2. * Infants who are medically stable per the clinical care team
  1. * Infants with major genetic or congenital anomalies known to be associated with developmental delay
  2. * Infants with severe brain injury (such as intraparenchymal hemorrhage, severe white matter injury)
  3. * Infants who are severely ill infants for whom MBI is not feasible
  4. * Infants of parents who cannot complete questionnaires in English or Spanish.

Contacts and Locations

Study Contact

Carmina Erdei, MD
CONTACT
6174620202
cerdei@bwh.harvard.edu
Yvonne Sheldon, RN, MS
CONTACT
6177327954
ysheldon@bwh.harvard.edu

Study Locations (Sites)

Yale New Haven Hospital
New Haven, Connecticut, 06510
United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115
United States

Collaborators and Investigators

Sponsor: Brigham and Women's Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-05-19
Study Completion Date2031-03-01

Study Record Updates

Study Start Date2025-05-19
Study Completion Date2031-03-01

Terms related to this study

Keywords Provided by Researchers

  • Preterm
  • Neurodevelopment
  • Music-based Intervention

Additional Relevant MeSH Terms

  • Infant Development
  • Language Development
  • Prematurity
  • Stress