Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06536296
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-10
Brief Title:
The Impact of Music Medicine on Preterm Brain Development and Behavior
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Impact of Music Medicine on Preterm Brain Development and Behavior - A Two-Center Randomized Controlled Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Detailed Description:
Preterm birth remains the leading cause of death for children under five For survivors it also accounts for high morbidity and substantial physical psychosocial emotional and financial burden for individuals families and communities The impairments span over multiple domains with language difficulties affecting about half of surviving children Evidence indicates that preterm birth has significant impacts on long-term functioning yet primary prevention of preterm birth is presently not feasible It is therefore imperative to prioritize early interventions to mitigate these adverse long-term effects on child and family outcomes
Very preterm VP infants ie those born below 32 weeks gestational age GA typically spend 2-4 months hospitalized in the Neonatal Intensive Care Unit NICU before reaching term-equivalent age TEA During this time the preterm brain nearly quadruples in volume and is highly sensitive to both positive and negative environmental experiences Yet during this period VP infants must also receive life-saving intensive medical care in the sensory-atypical environment of the NICU From an auditory perspective this atypical environment comprises loud equipment sounds at volumes far exceeding recommended levels silence and a paucity of human interaction One domain of neurosensory experience is the auditory environment comprised predominantly of non-meaningful high-frequency high decibel equipment sounds and silence The deprivation of VP infants from enriching auditory experiences parental voice infant-directed language combined with the constant influx of high frequencyhigh decibel sounds alarms and electronic noise can induce chronic stress and negatively impact auditory and other areas of cortical development
For preterm infants who have not yet reached term-equivalent age TEA the NICU hospitalization is a critical window for developmental adaptability to experience during a highly sensitive period of brain development There are two key pathways whereby music and voice therapy in the VP infant are thought to have benefit - stress reduction and auditory enrichment Recent work indicates that music therapy may reduce the immediate stress experienced by VP infants with evidence emerging on its impact to improve neurodevelopmental outcomes Prior studies have been limited due to small size variability of music exposures inconsistent study design and outcome measures Further most studies explored exposure-outcome associations without mechanistic investigation One study showed improved white matter maturation in acoustic radiations larger amygdala volumes and enhanced functional connectivity brain magnetic resonance imaging MRI after early music exposures These suggests that early music exposure may enhance auditory cortex development and reduce stress amygdala in VP infants
While small studies inform these hypotheses a large randomized trial is necessary to test them more rigorously Our own centers pilot study demonstrated that a music condition with low repetitive and rhythmically consistent entrainment stimulus was associated with improved physiologic state after the exposure Based on these data the investigators plan to further develop an individualized intervention encompassing evidence-based musical elements onto which parental voice will be carefully layered The aim of this proposal is to conduct a randomized trial to determine the effects of a protocolized music-based intervention MBI with and without parental voice on stress reduction early brain structure and function and neurodevelopmental outcomes
The investigators propose to address this knowledge gap in a large two-center randomized controlled trial RCT employing a novel MBI tailored based on available preliminary data and inclusive of musical and non-musical elements to facilitate parent engagement with comprehensive evaluation of relevant clinical neuroimaging and neurodevelopmental outcomes of VP infants up to two years of age The impact of this work will be two-fold this proposal will 1 generate rigorous evidence to specifically support the integration of music medicine as a therapeutic approach for VP infants in the NICU and 2 strengthen the evidence base for neurosensory interventions for hospitalized infants which will shift the framework of care in the NICU by leveraging developmental care interventions to optimize the outcomes of VP infants
Very preterm VP infants ie those born below 32 weeks gestational age GA typically spend 2-4 months hospitalized in the Neonatal Intensive Care Unit NICU before reaching term-equivalent age TEA During this time the preterm brain nearly quadruples in volume and is highly sensitive to both positive and negative environmental experiences Yet during this period VP infants must also receive life-saving intensive medical care in the sensory-atypical environment of the NICU From an auditory perspective this atypical environment comprises loud equipment sounds at volumes far exceeding recommended levels silence and a paucity of human interaction One domain of neurosensory experience is the auditory environment comprised predominantly of non-meaningful high-frequency high decibel equipment sounds and silence The deprivation of VP infants from enriching auditory experiences parental voice infant-directed language combined with the constant influx of high frequencyhigh decibel sounds alarms and electronic noise can induce chronic stress and negatively impact auditory and other areas of cortical development
For preterm infants who have not yet reached term-equivalent age TEA the NICU hospitalization is a critical window for developmental adaptability to experience during a highly sensitive period of brain development There are two key pathways whereby music and voice therapy in the VP infant are thought to have benefit - stress reduction and auditory enrichment Recent work indicates that music therapy may reduce the immediate stress experienced by VP infants with evidence emerging on its impact to improve neurodevelopmental outcomes Prior studies have been limited due to small size variability of music exposures inconsistent study design and outcome measures Further most studies explored exposure-outcome associations without mechanistic investigation One study showed improved white matter maturation in acoustic radiations larger amygdala volumes and enhanced functional connectivity brain magnetic resonance imaging MRI after early music exposures These suggests that early music exposure may enhance auditory cortex development and reduce stress amygdala in VP infants
While small studies inform these hypotheses a large randomized trial is necessary to test them more rigorously Our own centers pilot study demonstrated that a music condition with low repetitive and rhythmically consistent entrainment stimulus was associated with improved physiologic state after the exposure Based on these data the investigators plan to further develop an individualized intervention encompassing evidence-based musical elements onto which parental voice will be carefully layered The aim of this proposal is to conduct a randomized trial to determine the effects of a protocolized music-based intervention MBI with and without parental voice on stress reduction early brain structure and function and neurodevelopmental outcomes
The investigators propose to address this knowledge gap in a large two-center randomized controlled trial RCT employing a novel MBI tailored based on available preliminary data and inclusive of musical and non-musical elements to facilitate parent engagement with comprehensive evaluation of relevant clinical neuroimaging and neurodevelopmental outcomes of VP infants up to two years of age The impact of this work will be two-fold this proposal will 1 generate rigorous evidence to specifically support the integration of music medicine as a therapeutic approach for VP infants in the NICU and 2 strengthen the evidence base for neurosensory interventions for hospitalized infants which will shift the framework of care in the NICU by leveraging developmental care interventions to optimize the outcomes of VP infants
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None