The Effect of Music on Preterm Infant's Brain Development

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

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

Study Overview

• Status: Recruiting
• Conditions: Prematurity
• Intervention / Treatment: Other: Music

• Study Type: Interventional
• Enrollment (Estimated): 63
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Petra S. Hüppi, Prof.; Phone Number: +41 0223824352; Email: petra.huppi@hcuge.ch
• Study Contact Backup: Name: Lara Lordier, PhD; Phone Number: +41 0223725494; Email: lara.lordier@hcuge.ch

Study Locations

• Switzerland
  • Geneva, Switzerland, 1211
    • Recruiting
    • Prof. Petra S. Hüppi
    • Contact: Lara Lordier, PhD; Phone Number: +41 0223725494; Email: lara.lordier@hcuge.ch
    • Contact: Petra S. Huppi, Professor; Phone Number: +41 0223824352; Email: petra.huppi@hcuge.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 months to 9 months (Child)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Preterm music group; Music exposure with headphones	Other: Music; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Pediatric Clinical Research Platform

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2013
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: August 28, 2018
• First Submitted That Met QC Criteria: September 27, 2018
• First Posted (Actual): September 28, 2018

Study Record Updates

• Last Update Posted (Actual): April 11, 2024
• Last Update Submitted That Met QC Criteria: April 10, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Premature Birth
• Other Study ID Numbers: SNF 32473B_135817/1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No