The Effect of Music on Preterm Infant's Brain Development
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|ClinicalTrials.gov Identifier: NCT03689725|
Recruitment Status : Recruiting
First Posted : September 28, 2018
Last Update Posted : October 5, 2018
|Condition or disease||Intervention/treatment||Phase|
|Prematurity||Other: Music||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||63 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
Experimental: Preterm music group
Music exposure with headphones
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|
- 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.
- 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.
- 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
- 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)
- 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)
- 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)
- "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.
- 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.
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
|Contact: Petra S. Hüppi, Prof.||0223824352 ext +email@example.com|
|Contact: Lara Lordier, PhD||0223725494 ext +firstname.lastname@example.org|