No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
24 Weeks – 30 Weeks
Sex
Any
Study type
Interventional
Purpose
Prevention
Participants needed
243 (estimated)
Sponsor
Brigham and Women's Hospital · Other
Who this trial is looking for
This trial is looking for very preterm infants who were born early. Babies in the study will be exposed to music with or without a parent’s voice to see how it helps their brain development and reduces stress.
Are You a Good Fit for This Trial?
You may be able to join if
I am a very preterm infant born between 24 and 30 weeks.
I am from a level III NICU at Brigham and Women's Hospital or Yale New Haven.
I am medically stable as determined by the clinical care team.
You may not be able to join if
I have major genetic or congenital anomalies affecting development.
I have severe brain injury.
I am a severely ill infant where music therapy isn't feasible.
My parents cannot complete questionnaires in English or Spanish.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 …
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.
Trial Locations
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Eligibility Criteria
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…
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.
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