Personalized Music Therapy for Preterm Infants
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age5-15
SponsorFabrizio Faina
About this trial
Preterm infants in the Neonatal Intensive Care Unit (NICU) face environmental and clinical stressors that may affect physiological stability and development. This pilot randomized crossover study tests Personalized Music Therapy (PMT) based on recorded parental voices versus Quiet Rest. Outcomes include tissue oxygenation index (TOI) via near-infrared spectroscopy (NIRS) and heart rate (HR), respiratory rate (RR), and oxygen saturation (SpO2). Each infant completes two Periods (PMT and Quiet Rest) in randomized order, separated by a 2-day washout. Parental stress is measured at discharge using the Parental Stressor Scale: Neonatal Intensive Care Unit (PSS:NICU). Findings inform feasibility, variance estimates, and protocol refinements for a larger trial.
Eligibility criteria
Qualifiers
Preterm infants admitted to the Neonatal Intensive Care Unit (NICU) of Azienda Ospedaliera di Perugia, Santa Maria della Misericordia, Perugia (Italy) at the time of enrollment.
Gestational age at birth 28+0 to 36+6 weeks.
Age at enrollment: 5 to 15 days.
Stable vital signs at enrollment per unit policy.
Disqualifiers
Post-operative status at the time of enrollment.
One or more of the following: intraventricular hemorrhage, necrotizing enterocolitis, sepsis, significant pulmonary disease, or neonatal anemia.
Congenital anomalies.
Hypersensitivity or intolerance to sound.
Trial design
Treatments tested in this trial
- Personalized Music Therapy (PMT)
- Quiet Rest
Treatment groups
20 Participants
are divided into 2 treatment groupsSponsors and collaborators
Fabrizio Faina
Lead sponsor
Azienda Ospedaliera di Perugia
Sponsor institution
University Of Perugia
Collaborator
Source ClinicalTrials.gov