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The Effect of Music on Preterm Infant's Brain Development

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03689725
Recruitment Status : Recruiting
First Posted : September 28, 2018
Last Update Posted : October 5, 2018
Sponsor:
Information provided by (Responsible Party):
Pediatric Clinical Research Platform

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

Condition or disease Intervention/treatment Phase
Prematurity Other: Music Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 63 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Effect of Music on Functional Processing and Structural and Functional Development of the Preterm Infant's Brain
Actual Study Start Date : March 1, 2013
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2021

Arm Intervention/treatment
Experimental: Preterm music group
Music exposure with headphones
Other: Music
Music created by A. Vollenweider at least 5 times per week from 33 weeks of gestational age until term-equivalent age

No Intervention: Preterm control group
headphones without music
No Intervention: Full-term control group



Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. Functional responses to known and unknown music in preterm infants with music intervention will be compared to no-intervention groups responses using fMRI [ Time Frame: 40 weeks gestational age ]
    fMRI will be conducted in all three groups at term or term equivalent age

  2. Functional responses to known and unknown music in preterm infants with music intervention will be compared to no-intervention groups responses using EEG [ Time Frame: 40 weeks gestational age ]
    High density Electroencephalography (EEG) will be conducted in all three groups at term or term equivalent age (mismatch negativity, Delta Brushes)

  3. The music intervention effect on cognitive language and motor development at one and two years of age [ Time Frame: at 1 and 2 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)

  4. The music intervention effect on emotion and temperament at one and two years of age [ Time Frame: at 1 and 2 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.

  5. The music intervention effect on effortful control at one and two years of age [ Time Frame: at 2 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   33 Weeks to 42 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03689725


Contacts
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Contact: Petra S. Hüppi, Prof. 0223824352 ext +41 petra.huppi@hcuge.ch
Contact: Lara Lordier, PhD 0223725494 ext +41 lara.lordier@hcuge.ch

Locations
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Switzerland
Prof. Petra S. Hüppi Recruiting
Geneva, Switzerland, 1211
Contact: Petra S. Huppi, Professor    0223824352 ext +41    petra.huppi@hcuge.ch   
Contact: Lara Lordier, PhD    0223725494 ext +41    lara.lordier@hcuge.ch   
Sponsors and Collaborators
Pediatric Clinical Research Platform
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Responsible Party: Pediatric Clinical Research Platform
ClinicalTrials.gov Identifier: NCT03689725    
Other Study ID Numbers: SNF 32473B_135817/1
First Posted: September 28, 2018    Key Record Dates
Last Update Posted: October 5, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications