Back to resultsThe Effect of Music on Preterm Infant's Brain Development
Primary Purpose
Prematurity
Status
Unknown status
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Music
Sponsored by
About this trial
This is an interventional prevention trial for Prematurity
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
Sites / Locations
- Prof. Petra S. HüppiRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
No Intervention
No Intervention
Arm Label
Preterm music group
Preterm control group
Full-term control group
Arm Description
Music exposure with headphones
headphones without music
Outcomes
Primary Outcome Measures
Compare structural maturation in the three groups using structural MRI and DTI
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
An MRI will be conducted at term or term equivalent age including resting state functional magnetic resonance imaging (fMRI) measures.
Secondary Outcome Measures
Functional responses to known and unknown music in preterm infants with music intervention will be compared to no-intervention groups responses using fMRI
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
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
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
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.
The music intervention effect on effortful control at one and two 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.
Full Information
NCT ID
NCT03689725
First Posted
August 28, 2018
Last Updated
October 3, 2018
Sponsor
Pediatric Clinical Research Platform
1. Study Identification
Unique Protocol Identification Number
NCT03689725
Brief Title
The Effect of Music on Preterm Infant's Brain Development
Official Title
The Effect of Music on Functional Processing and Structural and Functional Development of the Preterm Infant's Brain
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2013 (Actual)
Primary Completion Date
December 31, 2019 (Anticipated)
Study Completion Date
December 31, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pediatric Clinical Research Platform
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Studying the effect of music intervention on preterm infants' brain development by MRI and neurodevelopmental assessments
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prematurity
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
63 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Preterm music group
Arm Type
Experimental
Arm Description
Music exposure with headphones
Arm Title
Preterm control group
Arm Type
No Intervention
Arm Description
headphones without music
Arm Title
Full-term control group
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
Music
Intervention Description
Music created by A. Vollenweider at least 5 times per week from 33 weeks of gestational age until term-equivalent age
Primary Outcome Measure Information:
Title
Compare structural maturation in the three groups using structural MRI and DTI
Description
An MRI will be conducted at term or term equivalent age including structural Magnetic Resonance Imaging and Diffusion Tensor Imaging (DTI) measures.
Time Frame
40 weeks gestational age
Title
Compare resting state maturation in the three groups using resting state fMRI
Description
An MRI will be conducted at term or term equivalent age including resting state functional magnetic resonance imaging (fMRI) measures.
Time Frame
40 weeks gestational age
Secondary Outcome Measure Information:
Title
Functional responses to known and unknown music in preterm infants with music intervention will be compared to no-intervention groups responses using fMRI
Description
fMRI will be conducted in all three groups at term or term equivalent age
Time Frame
40 weeks gestational age
Title
Functional responses to known and unknown music in preterm infants with music intervention will be compared to no-intervention groups responses using EEG
Description
High density Electroencephalography (EEG) will be conducted in all three groups at term or term equivalent age (mismatch negativity, Delta Brushes)
Time Frame
40 weeks gestational age
Title
The music intervention effect on cognitive language and motor development at one and two years of age
Description
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)
Time Frame
at 1 and 2 years of age
Title
The music intervention effect on emotion and temperament at one and two years of age
Description
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.
Time Frame
at 1 and 2 years of age
Title
The music intervention effect on effortful control at one and two years of age
Description
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.
Time Frame
at 2 years of age
10. Eligibility
Sex
All
Minimum Age & Unit of Time
33 Weeks
Maximum Age & Unit of Time
42 Weeks
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Petra S. Hüppi, Prof.
Phone
0223824352
Ext
+41
Email
petra.huppi@hcuge.ch
First Name & Middle Initial & Last Name or Official Title & Degree
Lara Lordier, PhD
Phone
0223725494
Ext
+41
Email
lara.lordier@hcuge.ch
Facility Information:
Facility Name
Prof. Petra S. Hüppi
City
Geneva
ZIP/Postal Code
1211
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Petra S. Huppi, Professor
Phone
0223824352
Ext
+41
Email
petra.huppi@hcuge.ch
First Name & Middle Initial & Last Name & Degree
Lara Lordier, PhD
Phone
0223725494
Ext
+41
Email
lara.lordier@hcuge.ch
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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The Effect of Music on Preterm Infant's Brain Development
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