Personalized Music Therapy for Preterm Infants

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.

NCT Number	NCT07295106
Lead Sponsor	Fabrizio Faina Collaborators: University Of Perugia
Conditions	Infant, Premature, Stress, Psychological
Enrollment	20 participants
Start Date	2025-10-13
Primary Completion	2026-01 (estimated)
Study Completion	2026-03 (estimated)
Updated on ClinicalTrials.gov	2025-12-19