Prematurity
Conditions
Brief summary
Studying the effect of music intervention on preterm infants' brain development by MRI and neurodevelopmental assessments
Interventions
OTHERMusic
Music created by A. Vollenweider at least 5 times per week from 33 weeks of gestational age until term-equivalent age
Sponsors
Pediatric Clinical Research Platform
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
33 Weeks to 42 Weeks
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Compare structural maturation in the three groups using structural MRI and DTI | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| The music intervention effect on cognitive language and motor development at one and two years of age | 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) |
| 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 | fMRI will be conducted in all three groups at term or term equivalent age |
| The music intervention effect on effortful control at one and two years of age | 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. |
| The music intervention effect on emotion and temperament at one and two years of age | 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. |
| 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 | High density Electroencephalography (EEG) will be conducted in all three groups at term or term equivalent age (mismatch negativity, Delta Brushes) |
Countries
Switzerland
Contacts
Primary ContactPetra S. Hüppi, Prof.
Backup ContactLara Lordier, PhD
Outcome results
None listed