Recruiting

Music & Parent Voice

Sponsor:

Brigham and Women's Hospital

Code:

NCT06536296

Conditions

Infant Development

Language Development

Prematurity

Stress

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

Interventions

Music

Music and parent voice

Standard Care

Study Details

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

Infant Development

Language Development

Prematurity

Stress

Study ID

NCT06536296

Start date

May 19, 2025

Status verified date

Jun, 2025

Completion date

Mar 1, 2031

Anticipated

Primary completion date

Aug 30, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

Inclusion 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

Exclusion Criteria:

  • 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.

Study Design

Enrollment

243 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Music

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.

experimental: Music and parent voice

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.

active comparator: Reference/ Standard of care

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.

Interventions

Music

Arm 1: Music only

Music and parent voice

Arm 2: Music and parent voice

Standard Care

Standard Care

Primary outcome measure

  • Bayley-4 language performance (SA3 primary outcome) [ Time Frame: 2 years corrected age ]
  • Amygdala volume on MRI (SA1a, primary outcome) [ Time Frame: At term-equivalent (~ 3 months of age), 37-41 weeks postmenstrual age (PMA) ]
  • Intranetwork connectivity in Salience and Language networks (SA2a, primary outcome) [ Time Frame: Term-equivalent (~ 3 months of age), 37-41 weeks postmenstrual age (PMA) ]

Central Contacts and Locations

Central contacts

Carmina Erdei, MD

6174620202cerdei@bwh.harvard.edu

Isabella J Lawandy

4014901670ilawandy@bwh.harvard.edu

Locations

Brigham and Women's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Elizabeth Singh, MSN

5125165360esingh@bwh.harvard.edu

More Information

Sponsor

Brigham and Women's Hospital

Last update posted

Mar 25, 2026

Last verified

Jun, 2025

Keywords

  • Preterm
  • Neurodevelopment
  • Music-based Intervention

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Brigham and Women's Hospital on 2026-03-25.