The Impact of Music Medicine on Preterm Brain Development and Behavior
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age24-30
SponsorBrigham and Women's Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Music
Other interventionArm 1: Music only
Music and parent voice
Other interventionArm 2: Music and parent voice
Standard Care
Other interventionStandard Care
Treatment groups
243 Participants
are divided into 3 treatment groupsGroup A: MusicExperimental treatment 1 intervention
Group B: Music and parent voiceExperimental treatment 1 intervention
Group C: Reference/ Standard of careActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Bayley-4 language performance (SA3 primary outcome)
Study patients Language performance measured on the Bayley-4 at 2 years corrected age
Time frame
2 years corrected age2
Amygdala volume on MRI (SA1a, primary outcome)
Amygdala volume as a proxy of cumulative stress measured on term-equivalent brain MRI
Time frame
At term-equivalent (~ 3 months of age), 37-41 weeks postmenstrual age (PMA)3
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
Time frame
Term-equivalent (~ 3 months of age), 37-41 weeks postmenstrual age (PMA)Secondary outcomes
1
Infant physiology - oxygen saturation
We will record infant physiologic vital signs (i.e. oxygen saturation) from infants' bedside monitor around each study intervention
Time frame
From enrollment to term-equivalent 37-41 weeks PMA2
Infant physiology - respiratory rate
We will record infant physiologic vital signs (i.e. respiratory rate) from infants' bedside monitor around each study intervention
Time frame
From enrollment to term-equivalent 37-41 weeks PMA3
Infant physiology - heart Rate
We will record infant physiologic vital signs (i.e. heart rate) from infants' bedside monitor around each study intervention
Time frame
From enrollment to term-equivalent 37-41 weeks PMA4
Telomere length
Assess infant premature aging at term-equivalent by measurement of telomere length on blood samples
Time frame
At enrollment and term-equivalent 37-41 weeks PMASponsors and contacts
Click on the lead sponsor to view all of their trials.
Brigham and Women's Hospital
Lead sponsor
Yale New Haven Health System Center for Healthcare Solutions
Collaborator
Source ClinicalTrials.gov