Actively Recruiting
Personalized Music Therapy for Preterm Infants
Led by Fabrizio Faina · Updated on 2025-12-19
20
Participants Needed
1
Research Sites
19 weeks
Total Duration
On this page
Sponsors
F
Fabrizio Faina
Lead Sponsor
U
University Of Perugia
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Personalized Music Therapy for Preterm Infants
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Preterm infants admitted to the NICU of Azienda Ospedaliera di Perugia, Santa Maria della Misericordia, Perugia (Italy) at enrollment
- Gestational age at birth between 28+0 and 36+6 weeks
- Age at enrollment between 5 and 15 days
- Stable vital signs at enrollment per unit policy
- Apgar score of 7 or higher at 5 minutes
- Birth weight appropriate for gestational age, between the 50th and 90th percentile
- Written informed consent from parent(s) or legal guardian(s)
You will not qualify if you...
- Post-operative status at enrollment
- Presence of 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
AI-Screening
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Trial Site Locations
Total: 1 location
1
Neonatal Intensive Care Unit (NICU), Ospedale Santa Maria della Misericordia - Azienda Ospedaliera di Perugia
Perugia, PG, Italy, 06129
Actively Recruiting
Research Team
F
Fabrizio Faina
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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