Premature BirthFunFreqNICUNCT06398912
Studying Newborns' Brain Activity in the NICU Through a Musical Intervention: the Role of Fundamental Frequency
A study testing Music Based Intervention in people with Premature Birth, run by Athens General Children's Hospital "Pan. & Aglaia Kyriakou" at 1 site in Greece.
Trial summary
This research project stands to the intersection of neonatology, neuroscience, and music based interventions (MBIs), exploring the impact of structured sound on the brain activity of premature newborns in Neonatal Intensive Care Units (NICU). Read more about this study
- Who is it for?
- Ages 28 to 32 weeksHealthy volunteers can take part
- Conditions the study is for
- Premature Birth
- What is being tested?
- Music Based Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteGreece
- Study dates
- 20 Apr 2023to 30 Jul 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 28 to 32 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Born at (equal or less than) 32 weeks of gestation
- Absence of auditory insufficiency in the 8th cranial nerve and excessive pathology in the brainstem
- Negative bilateral "transient evoked otoacoustic emissions," indicating unresponsiveness of the inner ear to an acoustic stimulus.
- Weighing 1000 grams or more
- In stable health conditions with no imminent risk of death
- Not sedated
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- Absence of neonatal sepsis.
- No congenital, genetic, or chromosomal abnormalities.
- No nuclear jaundice.
- No maternal use of illicit drugs during pregnancy.
- No necessity for mechanical ventilation that creates excessive noise (i.e., high-frequency oscillatory ventilation).
- No need for sedative drug administration to the neonate.
- Absence of endocrine disorders (e.g., congenital hypothyroidism).
Who cannot join
- If a newborn is diagnosed with a disease or dysfunction during the study and the medical staff recommends their removal, they will be automatically excluded from the recruited sample.
- Use of other music stimulation during the implementation of the intervention period
Trial locations and contacts
1 site in 1 country.
About this study
This research project stands to the intersection of neonatology, neuroscience, and music based interventions (MBIs), exploring the impact of structured sound on the brain activity of premature newborns in Neonatal Intensive Care Units (NICU). It embarks on a pioneering investigation to decipher how variations in musical stimuli, particularly those that differ in human profiles (gender and kinship) and fundamental frequencies, affect the short-term electroencephalographic (EEG) footprint of these vulnerable infants. The project aims to uncover profound insights into the therapeutic potential of music within neonatal care, thereby advancing our understanding of neurodevelopmental interventions for premature infants.
Read the detailed description
Research Design and Methodology
Adopting an exploratory/randomized control trial (RCT) design, this study is meticulously planned to evaluate the effects of musical interventions on premature infants housed within a NICU setting. Therefore, participants, specifically newborns born at ≤ 32 weeks of gestation who meet stringent inclusion criteria, are randomly assigned to either an intervention group that receives structured musical interventions for a week or a control group that does not receive any musical stimulation. This methodological approach ensures a controlled examination of the intervention's efficacy, attributing observed neurophysiological changes directly to the musical stimuli.
Data Collection Protocol
The data collection protocol employs a dual approach: quantitative EEG for capturing the infants' brain activity and qualitative video recordings to document the dynamic interactions between the infants and the music facilitators. This multifaceted strategy ensures a comprehensive analysis of the effects of musical interventions, facilitated by a diverse group of individuals including male and female music therapists, and the infants' parents. Such diversity allows for a nuanced exploration of how different human profiles influence the intervention's impact on brain activity patterns.
Tools for Data Collection
The primary instrument for data collection is an 6-channel EEG system, chosen for its precision in measuring the complex electrical dynamics of the infants' brains. This is complemented by a high definition video camera that aims to capture the qualitative dimensions of the intervention, such as the infants' behavioral responses and the nuanced interaction dynamics between the infant and the facilitator. Together, these tools promise a holistic dataset that bridges the gap between neurophysiological and behavioral observations.
Data Analysis Protocol
The data analysis framework is comprehensive, incorporating (tentatively) a Repeated Measures Analysis of Variance (ANOVA) to scrutinize brain activity across different conditions, facilitators and qEEG features. This is to dissect the EEG data across the available condition variables, identifying specific patterns and variations indicative of the musical stimuli's impact.
Significance and Expected Outcomes
By melding advanced methodological design with innovative data collection and analysis techniques, the project is uniquely positioned to elucidate the neurodevelopmental benefits of musical interventions for premature infants in the NICU environment.
- Conditions
- Premature Birth
- Being tested
- Music Based Intervention
- Keywords
- Premature Infants, Music, Brain Development, Pediatrics, Neonatology
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music Based InterventionOther
Also called Fundamental Frequency and Brain Development Intervention
Measuring how the fundamental frequency of differential music facilitators (mother, father, male and female music therapist) impacts the premature infant brain
| Study group | Role | What they receive |
|---|---|---|
| Music Intervention | Experimental | Participants will be exposed to an organized sound stimulus (music) during the EEG measurement Receives: Other: Music Based Intervention |
| Control Group | No intervention | Participants will not be exposed to an organized sound stimulus at any point of the EEG measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
qEEG features changes before, during and after the delivery of the musical intervention correlated to the fundamental frequency of the signing voice of the music facilitators
a predefined set of qEEG features (rEEG, coherence, spectral power etc) will be measured and analyzed via a 6 channels EEG unit in the NICU,
Measured: up to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2024
- Study start20 Apr 2023
- Primary completion30 Jul 2025
- Study completion30 Jul 2025
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 Premature BirthStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Athens General Children's Hospital "Pan. & Aglaia Kyriakou"
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Angeliki Nika, Athens General Children's Hospital "Pan. & Aglaia Kyriakou"
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06398912
- Sponsor's protocol ID
- 09th/04-05-2023 (Θ: 9)
- Acronym
- FunFreqNICU
- Status last verified
- Aug 2025
- First submitted
- 23 Apr 2024
- Last updated
- 22 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Papatzikis E, Dimitropoulos K, Tataropoulou K, Kyrtsoudi M, Pasoudi E, O'Toole JM, Nika A. The father's singing voice may impact premature infants' brain more than their mother's: A NICU single-arm exploratory study protocol and preliminary data on a singing and EEG framework based on the fundamental frequency of voice and kinship. PLoS One. 2025 Aug 14;20(8):e0328211. doi: 10.1371/journal.pone.0328211. eCollection 2025.
PubMed 40811513
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Studying Newborns' Brain Activity in the NICU Through a Musical Intervention: the Role of Fundamental Frequency
- ClinicalTrials.gov ID
- NCT06398912
- Acronym / sponsor ID
- FunFreqNICU / 09th/04-05-2023 (Θ: 9)
- Conditions
- Premature Birth
- Keywords
- Premature Infants, Music, Brain Development, Pediatrics, Neonatology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Athens General Children's Hospital "Pan. & Aglaia Kyriakou"University, hospital or other
- Study start
- 20 Apr 2023 (actual)
- Primary completion
- 30 Jul 2025 (actual)
- Study completion
- 30 Jul 2025 (actual)
- First posted
- 3 May 2024 (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.
This research project stands to the intersection of neonatology, neuroscience, and music based interventions (MBIs), exploring the impact of structured sound on the brain activity of premature newborns in Neonatal Intensive Care Units (NICU). It embarks on a pioneering investigation to decipher how variations in musical stimuli, particularly those that differ in human profiles (gender and kinship) and fundamental frequencies, affect the short-term electroencephalographic (EEG) footprint of these vulnerable infants. The project aims to uncover profound insights into the therapeutic potential of music within neonatal care, thereby advancing our understanding of neurodevelopmental interventions for premature infants.
Detailed description
Research Design and Methodology
Adopting an exploratory/randomized control trial (RCT) design, this study is meticulously planned to evaluate the effects of musical interventions on premature infants housed within a NICU setting. Therefore, participants, specifically newborns born at ≤ 32 weeks of gestation who meet stringent inclusion criteria, are randomly assigned to either an intervention group that receives structured musical interventions for a week or a control group that does not receive any musical stimulation. This methodological approach ensures a controlled examination of the intervention's efficacy, attributing observed neurophysiological changes directly to the musical stimuli.
Data Collection Protocol
The data collection protocol employs a dual approach: quantitative EEG for capturing the infants' brain activity and qualitative video recordings to document the dynamic interactions between the infants and the music facilitators. This multifaceted strategy ensures a comprehensive analysis of the effects of musical interventions, facilitated by a diverse group of individuals including male and female music therapists, and the infants' parents. Such diversity allows for a nuanced exploration of how different human profiles influence the intervention's impact on brain activity patterns.
Tools for Data Collection
The primary instrument for data collection is an 6-channel EEG system, chosen for its precision in measuring the complex electrical dynamics of the infants' brains. This is complemented by a high definition video camera that aims to capture the qualitative dimensions of the intervention, such as the infants' behavioral responses and the nuanced interaction dynamics between the infant and the facilitator. Together, these tools promise a holistic dataset that bridges the gap between neurophysiological and behavioral observations.
Data Analysis Protocol
The data analysis framework is comprehensive, incorporating (tentatively) a Repeated Measures Analysis of Variance (ANOVA) to scrutinize brain activity across different conditions, facilitators and qEEG features. This is to dissect the EEG data across the available condition variables, identifying specific patterns and variations indicative of the musical stimuli's impact.
Significance and Expected Outcomes
By melding advanced methodological design with innovative data collection and analysis techniques, the project is uniquely positioned to elucidate the neurodevelopmental benefits of musical interventions for premature infants in the NICU environment.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Music Intervention | Experimental | Other: Music Based InterventionParticipants will be exposed to an organized sound stimulus (music) during the EEG measurement |
| Control Group | No intervention | –Participants will not be exposed to an organized sound stimulus at any point of the EEG measurement |
Who may qualify
- Ages
- 28 to 32 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (13 listed)
- Born at (equal or less than) 32 weeks of gestation
- Absence of auditory insufficiency in the 8th cranial nerve and excessive pathology in the brainstem
- Negative bilateral "transient evoked otoacoustic emissions," indicating unresponsiveness of the inner ear to an acoustic stimulus.
- Weighing 1000 grams or more
- In stable health conditions with no imminent risk of death
Key exclusion criteria (2 listed)
- If a newborn is diagnosed with a disease or dysfunction during the study and the medical staff recommends their removal, they will be automatically excluded from the recruited sample.
- Use of other music stimulation during the implementation of the intervention period
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 |
|---|---|---|
| Music Based InterventionAlso: Fundamental Frequency and Brain Development InterventionMeasuring how the fundamental frequency of differential music facilitators (mother, father, male and female music therapist) impacts the premature infant brain | Other | Music Intervention |
Primary outcome
qEEG features changes before, during and after the delivery of the musical intervention correlated to the fundamental frequency of the signing voice of the music facilitators
Time frame: up to 18 months
a predefined set of qEEG features (rEEG, coherence, spectral power etc) will be measured and analyzed via a 6 channels EEG unit in the NICU,
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2025.
- Derived from this study: PubMed 40811513Papatzikis E, Dimitropoulos K, Tataropoulou K, Kyrtsoudi M, Pasoudi E, O'Toole JM, Nika A. The father's singing voice may impact premature infants' brain more than their mother's: A NICU single-arm exploratory study protocol and preliminary data on a singing and EEG framework based on the fundamental frequency of voice and kinship. PLoS One. 2025 Aug 14;20(8):e0328211. doi: 10.1371/journal.pone.0328211. eCollection 2025.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Based Intervention in people with Premature Birth, run by Athens General Children's Hospital "Pan. & Aglaia Kyriakou" at 1 site in Greece.
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 13 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: finished, as of the sponsor's last update on 22 Aug 2025. 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 Greece. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
qEEG features changes before, during and after the delivery of the musical intervention correlated to the fundamental frequency of the signing voice of the music facilitators (time frame: up to 18 months). 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 NCT06398912, 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 22 Aug 2025.