The Effect of Music on Preterm Infant's Brain Development

Not Applicable

Recruiting

• Conditions: Prematurity
• Interventions: Other: Music

• Registration Number: NCT03689725
• Lead Sponsor: Pediatric Clinical Research Platform

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2013-03-01
• Study First Submitted: 2018-08-28
• Study First Submitted QC: 2018-09-27
• Study First Posted: 2018-09-28
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-10
• Last Update Posted: 2024-04-11
• Primary Completion: 2024-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 63

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Preterm music group	Music	Music exposure with headphones

Primary Outcome Measures

Name	Time	Method
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.
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.

Secondary Outcome Measures

Name	Time	Method
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.
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 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)
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)

Trial Locations

Locations (1)

Prof. Petra S. Hüppi; 🇨🇭 Geneva, Switzerland