The Effect of Music on Preterm Infant's Brain Development

Prematurity Clinical Trial

Official title:

The Effect of Music on Functional Processing and Structural and Functional Development of the Preterm Infant's Brain

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03689725
• Other study ID #: SNF 32473B_135817/1
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2013
• Est. completion date: December 31, 2025

Study information

• Verified date: April 2024
• Source: Pediatric Clinical Research Platform
• Contact: Petra S. Hüppi, Prof.
• Phone: 0223824352
• Email: petra.huppi[@]hcuge.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 63
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 33 Weeks to 42 Weeks

Eligibility

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

Related Conditions & MeSH terms

• Premature Birth
• Prematurity

Intervention

Other:
• Music
Music created by A. Vollenweider at least 5 times per week from 33 weeks of gestational age until term-equivalent age

Locations

Country	Name	City	State
Switzerland	Prof. Petra S. Hüppi	Geneva

Sponsors (1)

Lead Sponsor	Collaborator
Pediatric Clinical Research Platform

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	40 weeks gestational age
Primary	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.	40 weeks gestational age
Secondary	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	40 weeks gestational age
Secondary	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)	40 weeks gestational age
Secondary	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)	at 1 and 2 years of age
Secondary	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.	at 1 and 2 years of age
Secondary	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.	at 2 years of age