Clinical trial NCT06650189: Investigation of the Effect of muSic on the Stress of Preterm neONates Through innovATive Applications (SONATA)
Official title: Investigation of the Effect of Music on the Stress of Preterm Neonates Through Innovative Applications
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Premature Neonates
Keywords: preterm neonates
premature neonates
stress
salivary biomarkers
NICU
preterm infants
premature infants
music
Lead sponsor: University of West Attica
Sponsor class: OTHER
Collaborators: name: General and Maternity Hospital of Athens Elena Venizelou
name: Attikon Hospital
First posted: 2024-10-21
Enrollment: 70
Sex: ALL
Minimum age (years): 28
Maximum age (years): 37
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: Study Design In this prospective randomized controlled clinical trial, live born preterm neonates should have a stable clinical status at the time of study enrollment and therefore it is likely that some neonates will be enrolled after 5-7 days of admission. The allocation of neonates will be randomized in order to equalize the prognostic factors (confounding factors) between the groups. By using sequentially numbered envelopes, participants will be assigned to either intervention or control group by simple random allocation. In this way, researchers will avoid resulting in an unequal number of participants between the two groups. Researchers after obtaining parental informed consent, will request a sealed envelope from a staff member not involved in the study. The envelope will be opened and the allocation will be documented on a list, and signed by a member of the research team and a staff member as witness.

Participants The study will recruit preterm neonates. It has been estimated that with a sample of 35 neonates per group, the study will have more than 85% power to find differences in biomarkers between the intervention and control group, with an effect size equal to or greater than 0.72 and a significance level of 0.05.

Music Intervention Neonates will be placed in a closed incubator whose acoustic properties have been previously studied. Under the close surveillance of a team member, monitor alarms will be also silenced so as to decrease exposure to sudden and unpleasant auditory stimuli during music intervention. A mini portable speaker will be settled inside the incubator in appropriate conditions (volume level, distance e.t.c) for safety reasons.

Neonates allocated to the intervention group will be exposed to a specific piece of music, 30 minutes after feeding (if oral feeding exists), for a duration no more than 30 minutes that will be indicated from the certified music - therapist, experienced in working with preterm infants.

A questionnaire created by the research team will be administered to parents in order to investigate the neonate's prenatal exposure of music (as a fetus).

Data collection Biomarkers Salivary samples will be obtained from preterm neonates via salivette swabs. The polyester filter of the device will be partitioned into equal sections under sterile conditions to account for the small oral size of the neonates. One sample will be obtained before the music intervention and one sample 60 minutes after the music intervention, considering diurnal flow patterns. Saliva sampling is unlikely to cause stress or pain to the neonate. In the control group only one sample per day will be obtained within the same time period with the intervention group. Sample collection will be repeated in the same way everyday for 5 consecutive days. Each sample will be obtained before any stressful intervention (e.g. blood sampling, weighing, bathing, etc.). Furthermore, it is important to note that no other procedure that may reduce stress will take place simultaneously with music intervention (i.e. kangaroo care, gentle touching e.t.c) in order to interpret the effect of music more precisely. Saliva samples will be centrifuged very soon after collection and stored at -80oC until the laboratory analyses are performed. Measurements will be performed with cobas e411 automated analyzer or through ELISA.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

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

Primary outcomes:
measure: Salivary stress biomarker 1 - Hormone
timeFrame: From enrollment to 5 consecutive days.
measure: Salivary stress biomarker 2 - Enzyme
timeFrame: From enrollment to 5 consecutive days.
measure: Salivary stress biomarker 3 - Protein
timeFrame: From enrollment to 5 consecutive days.
Secondary outcomes:
measure: Heart rate
timeFrame: Measured before, during, and after each music session daily. From enrollment to the end of intervention at 5 days.
measure: Respiratory rate
timeFrame: Measured before, during, and after each music session daily. From enrollment to the end of intervention at 5 days.
measure: Oxygen saturation
timeFrame: Measured before, during, and after each music session daily. From enrollment to the end of intervention at 5 days.
measure: Blood pressure
timeFrame: Measured before, during, and after each music session daily. From enrollment to the end of intervention at 5 days.
measure: Weight
timeFrame: Measured daily, with cumulative weight gain assessed at the end of the 5 days.
measure: Head circumference
timeFrame: Day 1 and 5.
measure: Daily volume of milk consumed.
timeFrame: Feeding efficiency will be analyzed over the 5-day period.
measure: Length of hospitalization
timeFrame: From the date of hospital admission to the date of discharge, assessed up to 6 months.
Other outcomes:
Locations:
city: Athens
country: Greece
facility: General and Maternity Hospital of Athens Elena Venizelou
city: Chaidari
country: Greece
facility: Attikon General University Hospital
Study officials:
References: