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Behavioural Intervention

Music Therapy for Premature Infants

N/A
Waitlist Available
Research Sponsored by Brigham and Women's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Must not have
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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years corrected age
Awards & highlights

Summary

This trial aims to study the effects of music with or without parent voice on very premature infants' stress levels, brain connectivity, and development. The researchers believe that infants who receive music with parent voice will

Who is the study for?
This trial is for very preterm infants to explore how music and parent voice can affect their brain development and behavior. Infants must be born prematurely and will be observed until they are two years old. Specific details on inclusion or exclusion criteria were not provided.
What is being tested?
The study tests the effects of music alone (M) or combined with a parent's voice (MPV) versus standard care on stress levels, brain development, and language outcomes in premature infants. It's a randomized control trial conducted at two sites.
What are the potential side effects?
Since this trial involves non-invasive interventions like music and parental voices, there are no direct medical side effects expected as part of the study.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
My infant has a genetic condition linked to developmental delays.
Select...
My infant has a severe brain injury.
Select...
My parents are not able to fill out forms in English or Spanish.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years corrected age
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years corrected age for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Amygdala volume on MRI (SA1a, )
Bayley-4 language performance (SA3 )
Intranetwork connectivity in Salience and Language networks (SA2a, )
Secondary study objectives
Brain development
Infant Neurobehavior
Infant physiology - heart Rate
+8 more

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Music and parent voiceExperimental Treatment1 Intervention
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.
Group II: MusicExperimental Treatment1 Intervention
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.
Group III: Reference/ Standard of careActive Control1 Intervention
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.

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Who is running the clinical trial?

Brigham and Women's HospitalLead Sponsor
1,653 Previous Clinical Trials
11,490,792 Total Patients Enrolled
Yale New Haven Health System Center for Healthcare SolutionsOTHER
5 Previous Clinical Trials
5,084 Total Patients Enrolled
~162 spots leftby Aug 2029
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