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Clinical Trials/NCT03689725
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

Registry
clinicaltrials.gov
Start Date
March 1, 2013
End Date
December 31, 2025
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Pediatric Clinical Research Platform
Responsible Party
Sponsor

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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