The Effect of Music on Preterm Infant's Brain Development

April 10, 2024 updated by: Pediatric Clinical Research Platform

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
63

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Compare structural maturation in the three groups using structural MRI and DTI
Time Frame: 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.
40 weeks gestational age
Compare resting state maturation in the three groups using resting state fMRI
Time Frame: 40 weeks gestational age
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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
Time Frame: 40 weeks gestational age
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
Time Frame: 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)
40 weeks gestational age
The music intervention effect on cognitive language and motor development at one and two years of age
Time Frame: 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)
at 1 and 2 years of age
The music intervention effect on emotion and temperament at one and two years of age
Time Frame: 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.
at 1 and 2 years of age
The music intervention effect on effortful control at one and two years of age
Time Frame: 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.
at 2 years of age

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pediatric Clinical Research Platform

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2013

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 28, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 27, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 28, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 11, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 10, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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