The Effect of Music on Preterm Infant's Brain Development

Study Overview
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Brief Summary
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Studying the effect of music intervention on preterm infants' brain development by MRI and neurodevelopmental assessments

Official Title
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The Effect of Music on Functional Processing and Structural and Functional Development of the Preterm Infant's Brain

Conditions
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Prematurity

Intervention / Treatment
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* Other: Music


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Preterm infants: 33 weeks < gestational age < 37 weeks Full-term newborns: 37 weeks gestational age < 42 weeks Exclusion Criteria: Neurological issues or malformations (such as III-IV stade Intraventricular hemorrhage, micro or macrocephaly, hydrocephaly...) Because of the high noise caused by nasal continuous positive airway pressure (nCPAP), preterm newborns without at least nCPAP pause before 32 6/7 gestational age will be excluded

Ages Eligible for Study
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Minimum Age: 33 Weeks
Maximum Age: 42 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Preterm music group<br>Music exposure with headphones | Other: Music<br>* Music created by A. Vollenweider at least 5 times per week from 33 weeks of gestational age until term-equivalent age<br>|
| No Intervention: Preterm control group<br>headphones without music | |
| No Intervention: Full-term control group<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare structural maturation in the three groups using structural MRI and DTI | An MRI will be conducted at term or term equivalent age including structural Magnetic Resonance Imaging and Diffusion Tensor Imaging (DTI) measures. | 40 weeks gestational age | 
| Compare resting state maturation in the three groups using resting state fMRI | An MRI will be conducted at term or term equivalent age including resting state functional magnetic resonance imaging (fMRI) measures. | 40 weeks gestational age | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional responses to known and unknown music in preterm infants with music intervention will be compared to no-intervention groups responses using fMRI | fMRI will be conducted in all three groups at term or term equivalent age | 40 weeks gestational age | 
| Functional responses to known and unknown music in preterm infants with music intervention will be compared to no-intervention groups responses using EEG | High density Electroencephalography (EEG) will be conducted in all three groups at term or term equivalent age (mismatch negativity, Delta Brushes) | 40 weeks gestational age | 
| The music intervention effect on cognitive language and motor development at one and two years of age | Bayley III Cognitive / Language (receptive / expressive) / Motor (fine / gross) Child's performance is compared with norms taken from typically developing children of their age (in months) | at 1 and 2 years of age | 
| The music intervention effect on emotion and temperament at one and two years of age | LABoratory Temperament Assessment Battery (LabTAB) Four episodes: Puppet Game: Joy (mean of Facial, Vocal, and Bodily responses 0-3); Avoidance (negative motor action 0-3) Attractive Toy Placed Behind Barrier: Frustration/Anger (0-3); Avoidance (0-3) Unpredictable Mechanical Toy: Fear (mean of Vocal and Facial responses 0-3) ; Approach (0-3) Blocks: Attention (mean of Manipulation, Regards, Facial interest 0-3) A higher score indicates more emotional reactivity during a specific emotion-eliciting situation. | at 1 and 2 years of age | 
| The music intervention effect on effortful control at one and two years of age | Effortful control battery Episodes: Snack Delay, Wrapped Gift, and Tower. These episodes evaluate two components of effortful control: delaying (waiting for a pleasant event) twice and suppressing or initiating activity to signal (taking turns), respectively. | at 2 years of age |