Studying Newborns' Brain Activity in the NICU Through a Musical Intervention: the Role of Fundamental Frequency

NCT06398912 | Completed

• 1 other identifier: 09th/04-05-2023 (Θ: 9)
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

Premature Birth

Keywords

Premature Infants; Music; Brain Development; Pediatrics; Neonatology

Outcome Measures

Primary Outcomes (1)

• 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,

  up to 18 months

Study Arms (2)

Music Intervention

EXPERIMENTAL

Participants will be exposed to an organized sound stimulus (music) during the EEG measurement

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

Interventions

Music Based Intervention OTHER

Measuring how the fundamental frequency of differential music facilitators (mother, father, male and female music therapist) impacts the premature infant brain

Also known as: Fundamental Frequency and Brain Development Intervention

Music Intervention

Eligibility Criteria

• Age: 28 Weeks - 32 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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
• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Athens General Children's Hospital "Pan. & Aglaia Kyriakou": lead

Study Sites (1)

Panagiotis and Aglaia Kyriakou Childrens Hospital

Athens, Greece

Location

Related Publications (1)

• 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.

  PMID: 40811513 DERIVED

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Neonatologist - Director of NICU

Study Record Dates

• First Submitted: April 23, 2024
• First Posted: May 3, 2024
• Study Start: April 20, 2023
• Primary Completion: July 30, 2025
• Study Completion: July 30, 2025
• Last Updated: August 22, 2025

Record last verified: 2025-08

Locations

GR (1)