Investigation of the Effect of muSic on the Stress of Preterm neONates Through innovATive Applications (SONATA)

NCT06650189 | Recruiting

• 1 other identifier: 44834
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 2

Brief Summary

The goal of this prospective randomized clinical trial is to investigate the effect of music intervention on the stress of live born preterm neonates requiring admission to a Neonatal Intensive Care Unit, through the measurements of salivary biomarkers (hormones and proteins). The main question it aims to answer is: Can the daily music intervention reduce the stress levels created by the Neonatal Intensive Care Unit environment in preterm neonates? Researchers will compare preterm neonates who will not be exposed to music intervention to investigate potential discrepancies in salivary stress biomarkers. Participants will be exposed to recorded music for 5 consecutive days.

Conditions

Premature Neonates

Keywords

preterm neonates; premature neonates; stress; salivary biomarkers; NICU; preterm infants; premature infants; music

Outcome Measures

Primary Outcomes (3)

• Salivary stress biomarker 1 - Hormone

  Concentration of the hormone (Units: μg/dL).

  From enrollment to 5 consecutive days.

• Salivary stress biomarker 2 - Enzyme

  Concentration of the enzyme (Units: U/L).

  From enrollment to 5 consecutive days.

• Salivary stress biomarker 3 - Protein

  Concentration of the protein (Units: μg/mL).

  From enrollment to 5 consecutive days.

Secondary Outcomes (8)

• Heart rate

  Measured before, during, and after each music session daily. From enrollment to the end of intervention at 5 days.

• Respiratory rate

  Measured before, during, and after each music session daily. From enrollment to the end of intervention at 5 days.

• Oxygen saturation

  Measured before, during, and after each music session daily. From enrollment to the end of intervention at 5 days.

• Blood pressure

  Measured before, during, and after each music session daily. From enrollment to the end of intervention at 5 days.

• Weight

  Measured daily, with cumulative weight gain assessed at the end of the 5 days.

Study Arms (2)

Standard of care

NO INTERVENTION

Preterm neonates will receive standard of care.

Music intervention

EXPERIMENTAL

Preterm neonates will be exposed to recorded music intervention. Recorded music will be played through a portable Bluetooth speaker (3.1 watt) placed in the incubator, which will be activated and controlled via a smartphone.

Other: Music intervention

Interventions

Music intervention OTHER

Recorded music created by a certified music therapist

Music intervention

Eligibility Criteria

• Age: 28 Weeks - 37 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Born between 28 - 36+6 weeks of gestation
• Absence of active infection including blood, urine, cerebrospinal fluid
• Absence of congenital and genetic disorders and chromosomal abnormalities
• Absence of nuclear jaundice
• Absence of endocrine disorders
• Absence of maternal use of illicit drugs prenatally
• Non - sedated neonates
• Positive bilateral transient evoked otoacoustic emissions
• Stable clinical condition
• Absence of brain injury

You may not qualify if:

• Diagnosis of brain injury after the enrollment
• Negative auditory brainstem response before discharge
• Clinical deterioration

Sponsors & Collaborators

• University of West Attica: lead
• General and Maternity Hospital of Athens Elena Venizelou: collaborator
• Attikon Hospital: collaborator

Study Sites (2)

General and Maternity Hospital of Athens Elena Venizelou

Athens, 11521, Greece

RECRUITING

Attikon General University Hospital

Chaïdári, 12462, Greece

NOT YET RECRUITING

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Dimitra Metallinou, Assistant Professor

CONTACT

2105387410; dmetallinou@uniwa.gr

Maria Tzeli, PhD candidate

CONTACT

6978815559; mtzeli@uniwa.gr

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: Assistant Professor

Study Record Dates

• First Submitted: September 27, 2024
• First Posted: October 21, 2024
• Study Start: July 1, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: April 1, 2025

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Beginning 1 year after publication with no end date.
• Access Criteria: Access to de-identified individual participant data (IPD) will be granted to qualified researchers upon reasonable request. Interested parties/research groups must submit a written proposal outlining the intended purpose, type of analysis to be conducted, and justification for access to the data. Data sharing will require the execution of a formal Data Sharing Agreement (DSA) to ensure data use is consistent with ethical and legal standards, including participant confidentiality and proper data handling. Requests will be reviewed by the Principal Investigator and/or a designated review panel. Evaluation will consider the scientific merit of the proposal, qualifications of the requesting researcher(s), and ethical considerations. Communication and submission of the proposal and signed DSA can be done via email to the Primary Investigator. Please contact the Primary Investigator directly for more information or to initiate a request.

Locations

GR (2)