PrematurityNCT03689725
The Effect of Music on Preterm Infant's Brain Development
A study testing Music in people with Prematurity, run by Pediatric Clinical Research Platform at 1 site in Switzerland.
Trial summary
Studying the effect of music intervention on preterm infants' brain development by MRI and neurodevelopmental assessments Read more about this study
- Who is it for?
- Ages 33 to 42 weeksHealthy volunteers can take part
- Conditions the study is for
- Prematurity
- What is being tested?
- Music
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Mar 2013to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 33 to 42 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Preterm infants: 33 weeks < gestational age < 37 weeks
- Full-term newborns: 37 weeks gestational age < 42 weeks
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
Prof. Petra S. Hüppi
Geneva, 1211
Petra S. Huppi, Professor, 0223824352 ext. +41, petra.huppi@hcuge.ch
Lara Lordier, PhD, 0223725494 ext. +41, lara.lordier@hcuge.ch
About this study
Official title: 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
- Conditions
- Prematurity
- Being tested
- Music
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MusicOther
Music created by A. Vollenweider at least 5 times per week from 33 weeks of gestational age until term-equivalent age
| Study group | Role | What they receive |
|---|---|---|
| Preterm music group | Experimental | Music exposure with headphones Receives: Other: Music |
| Preterm control group | No intervention | headphones without music |
| Full-term control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 40 weeks gestational age
Secondary outcomes (5)
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
Measured: 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)
Measured: 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)
Measured: 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.
Measured: 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.
Measured: at 2 years of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2018
- Study start1 Mar 2013
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PrematurityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 63 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pediatric Clinical Research Platform
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03689725
- Sponsor's protocol ID
- SNF 32473B_135817/1
- Status last verified
- Apr 2024
- First submitted
- 28 Aug 2018
- Last updated
- 11 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Sa de Almeida J, Baud O, Fau S, Barcos-Munoz F, Courvoisier S, Lordier L, Lazeyras F, Huppi PS. Music impacts brain cortical microstructural maturation in very preterm infants: A longitudinal diffusion MR imaging study. Dev Cogn Neurosci. 2023 Jun;61:101254. doi: 10.1016/j.dcn.2023.101254. Epub 2023 May 11.
PubMed 37182337
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Music on Functional Processing and Structural and Functional Development of the Preterm Infant's Brain
- ClinicalTrials.gov ID
- NCT03689725
- Acronym / sponsor ID
- SNF 32473B_135817/1
- Conditions
- Prematurity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 63 participants (estimated)
- Lead sponsor
- Pediatric Clinical Research PlatformUniversity, hospital or other
- Study start
- 1 Mar 2013 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 28 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Studying the effect of music intervention on preterm infants' brain development by MRI and neurodevelopmental assessments
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Preterm music group | Experimental | Other: MusicMusic exposure with headphones |
| Preterm control group | No intervention | –headphones without music |
| Full-term control group | No intervention | – |
Who may qualify
- Ages
- 33 to 42 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Preterm infants: 33 weeks < gestational age < 37 weeks
- Full-term newborns: 37 weeks gestational age < 42 weeks
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MusicMusic created by A. Vollenweider at least 5 times per week from 33 weeks of gestational age until term-equivalent age | Other | Preterm music group |
Primary outcome
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.
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.
5 secondary outcomes
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
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
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
The music intervention effect on emotion and temperament at one and two years of age
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2024.
- Derived from this study: PubMed 37182337Sa de Almeida J, Baud O, Fau S, Barcos-Munoz F, Courvoisier S, Lordier L, Lazeyras F, Huppi PS. Music impacts brain cortical microstructural maturation in very preterm infants: A longitudinal diffusion MR imaging study. Dev Cogn Neurosci. 2023 Jun;61:101254. doi: 10.1016/j.dcn.2023.101254. Epub 2023 May 11.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Music in people with Prematurity, run by Pediatric Clinical Research Platform at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Petra S. Hüppi, Prof. (0223824352 ext. +41, petra.huppi@hcuge.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare structural maturation in the three groups using structural MRI and DTI (time frame: 40 weeks gestational age). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03689725, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2024.