The Impact of Music Medicine on Preterm Brain Development and Behavior

NCT06536296 | Recruiting

• 1 other identifier: 2024P001561
• Study Type: interventional
• Target: 243
• Locations: 1 country
• Sites: 2

Brief 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

Language Development; Prematurity; Stress; Infant Development

Keywords

Preterm; Neurodevelopment; Music-based Intervention

Outcome Measures

Primary Outcomes (3)

• Bayley-4 language performance (SA3 primary outcome)

  Study patients Language performance measured on the Bayley-4 at 2 years corrected age

  2 years corrected age

• Amygdala volume on MRI (SA1a, primary outcome)

  Amygdala volume as a proxy of cumulative stress measured on term-equivalent brain MRI

  At term-equivalent (~ 3 months of age), 37-41 weeks postmenstrual age (PMA)

• Intranetwork connectivity in Salience and Language networks (SA2a, primary outcome)

  We will measure the intranetwork connectivity in Salience and Language networks in infants exposed to music and music with parent voice compared those in SC arm at term-equivalent

  Term-equivalent (~ 3 months of age), 37-41 weeks postmenstrual age (PMA)

Secondary Outcomes (11)

• Infant physiology - oxygen saturation

  From enrollment to term-equivalent 37-41 weeks PMA

• Infant physiology - respiratory rate

  From enrollment to term-equivalent 37-41 weeks PMA

• Infant physiology - heart Rate

  From enrollment to term-equivalent 37-41 weeks PMA

• Telomere length

  At enrollment and term-equivalent 37-41 weeks PMA

• Neurodevelopmental assessment - cognitive outcomes

  2 years corrected age

Study Arms (3)

Music

EXPERIMENTAL

We will create three recordings with increasing complexity for each infant. For each infant developmental stage (32, 34, 36+ weeks PMA), Music Therapists (MTs) in both units will present parents with a curated list of 8-10 musically comparable, familiar lullabies to select from. Songs will be available in different languages reflective of patient diversity, with rhythm, tempo, pitch range/ change, instrumentation, melody, harmony selected drawing on available evidence, including BWH NICU pilot data. Timing: MBI to be administered after regular NICU "care and feeding" times, which are typically considered stressful times for infants. The goal of the intervention will be to provide a calming and relaxing experience to the infant as they "settle" back to sleep after handling times. Music delivery will occur via infant-adapted headphones to facilitate blinding.

Other: Music

Music and parent voice

EXPERIMENTAL

The selected lullabies will be pre-recorded by the MT as described above to include a guitar accompaniment track, and a separate vocal track with the MT singing along, in two separate keys to allow variation for parent voice range and comfort. Parents will be invited to sing along with the recorded track of MT singing, and MT will later remove the MT-voice recording track so only the parent voice will be heard with the guitar in the final recording. Timing: MBI to be administered after regular NICU "care and feeding" times, which are typically considered stressful times for infants. The goal of the intervention will be to provide a calming and relaxing experience to the infant as they "settle" back to sleep after handling times. Music delivery will occur via infant-adapted headphones to facilitate blinding.

Other: Music and parent voice

Reference/ Standard of care

ACTIVE COMPARATOR

These are infants recruited in the study who will receive the unit standard of care. They will be listening to the NICU ambient noise via infant-adapted headphones but will not receive any music intervention.

Other: Standard Care

Interventions

Music OTHER

Arm 1: Music only

Also known as: Arm 1: Music

Music

Music and parent voice OTHER

Arm 2: Music and parent voice

Also known as: Arm 2: Music and parent voice

Music and parent voice

Standard Care OTHER

Standard Care

Also known as: Arm 3: Standard Care

Reference/ Standard of care

Eligibility Criteria

• Age: 24 Weeks - 30 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• Yale New Haven Health System Center for Healthcare Solutions: collaborator

Study Sites (2)

Yale New Haven Hospital

New Haven, Connecticut, 06510, United States

NOT YET RECRUITING

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

MeSH Terms

Conditions

Premature Birth

Interventions

Music Therapy; Standard of Care

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Sensory Art Therapies; Complementary Therapies; Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Psychotherapy; Behavioral Disciplines and Activities; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Central Study Contacts

Carmina Erdei, MD

CONTACT

6174620202; cerdei@bwh.harvard.edu

Isabella J Lawandy

CONTACT

4014901670; ilawandy@bwh.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: We will utilize infant-adapted headphones to deliver the intervention in a blinded fashion. The research team (investigators and outcome assessors) will remain blinded to the type of recording delivered for each infant.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Neonatologist

Model Details: The eligible participants in both institutions will be consecutively approached to enroll in the study. Once informed consent has been obtained, each participant will be randomly assigned to one of the three study groups: M (music), MPV (music with parent voice), or SC (standard care), with 81 infants per each group. We designed the MBI in collaboration with board certified music therapists (MT) at the two institutions. While MBI recordings will be obtained at each NICU timepoint for each infant (with both M and MPV; SC group will wear headphones open to environmental sounds, as a control group), each infant will only listen to one of the three types of recordings according to their group assignment.

Study Record Dates

• First Submitted: July 10, 2024
• First Posted: August 2, 2024
• Study Start: May 19, 2025
• Primary Completion (Estimated): August 30, 2030
• Study Completion (Estimated): March 1, 2031
• Last Updated: March 25, 2026

Record last verified: 2025-06

Locations

US (2)