The Effect of Music on Preterm Infant's Brain Development

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

63 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-01

Study Completion Date

2025-12-31

Brief Summary

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

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Detailed Description

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Conditions

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Prematurity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Preterm music group

Music exposure with headphones

Group Type EXPERIMENTAL

Music

Intervention Type OTHER

Music created by A. Vollenweider at least 5 times per week from 33 weeks of gestational age until term-equivalent age

Preterm control group

headphones without music

Group Type NO_INTERVENTION

No interventions assigned to this group

Full-term control group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Music

Music created by A. Vollenweider at least 5 times per week from 33 weeks of gestational age until term-equivalent age

Intervention Type OTHER

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

Minimum Eligible Age

33 Weeks

Maximum Eligible Age

42 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes