NCT03689725
Recruiting
Not Applicable
The Effect of Music on Functional Processing and Structural and Functional Development of the Preterm Infant's Brain
Pediatric Clinical Research Platform1 site in 1 country63 target enrollmentMarch 1, 2013
ConditionsPrematurity
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Prematurity
- Sponsor
- Pediatric Clinical Research Platform
- Enrollment
- 63
- Locations
- 1
- Primary Endpoint
- Compare resting state maturation in the three groups using resting state fMRI
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
Studying the effect of music intervention on preterm infants' brain development by MRI and neurodevelopmental assessments
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Compare resting state maturation in the three groups using resting state fMRI
Time Frame: 40 weeks gestational age
An MRI will be conducted at term or term equivalent age including resting state functional magnetic resonance imaging (fMRI) measures.
Compare structural maturation in the three groups using structural MRI and DTI
Time Frame: 40 weeks gestational age
An MRI will be conducted at term or term equivalent age including structural Magnetic Resonance Imaging and Diffusion Tensor Imaging (DTI) measures.
Secondary Outcomes
- The music intervention effect on effortful control at one and two years of age(at 2 years of age)
- Functional responses to known and unknown music in preterm infants with music intervention will be compared to no-intervention groups responses using fMRI(40 weeks gestational age)
- The music intervention effect on cognitive language and motor development at one and two years of age(at 1 and 2 years of age)
- The music intervention effect on emotion and temperament at one and two years of age(at 1 and 2 years of age)
- Functional responses to known and unknown music in preterm infants with music intervention will be compared to no-intervention groups responses using EEG(40 weeks gestational age)
Study Sites (1)
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