Personalized Music Therapy for Preterm Infants
Recruiting now · Not applicable
Conditions studied: Infant, Premature, Stress, Psychological
In brief
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.
Key facts
- Study ID
- NCT07295106
- Run by
- Fabrizio Faina
- People needed
- 20
- Starts
- 2025-10-13
- Expected to finish
- 2026-03-01
- Last updated by the study team
- 2025-12-19
Who can join
Age: 0 and older, up to 0. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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).
You may not qualify if…
- 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.
Where it is running
- Neonatal Intensive Care Unit (NICU), Ospedale Santa Maria della Misericordia - Azienda Ospedaliera di Perugia — Perugia, PG, Italy (enrolling)
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.