Personalized Music Therapy for Preterm Infants

Summary

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

Inclusion Criteria:

* 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.
* Apgar score at 5 minutes ≥ 7.
* Birth weight appropriate for gestational age, between the 50th and 90th percentile.
* Written informed consent from parent(s) or legal guardian(s).

Exclusion Criteria:

* 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.
* Maternal history of drug and/or alcohol misuse during pregnancy.
* Lack of parental consent.

Conditions3

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