NCT07295106 Personalized Music Therapy for Preterm Infants
| NCT ID | NCT07295106 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fabrizio Faina |
| Condition | Infant, Premature |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2025-10-13 |
| Primary Completion | 2026-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 20 participants in total. It began in 2025-10-13 with a primary completion date of 2026-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07295106 clinical trial?
This trial is open to participants of all sexes, aged 5 Days or older, up to 15 Days, studying Infant, Premature. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07295106 currently recruiting?
Yes, NCT07295106 is actively recruiting participants. Contact the research team at fabrizio.faina@unipg.it for enrollment information.
Where is the NCT07295106 trial being conducted?
This trial is being conducted at Perugia, Italy.
Who is sponsoring the NCT07295106 clinical trial?
NCT07295106 is sponsored by Fabrizio Faina. The trial plans to enroll 20 participants.