Personalized parental-voice music for preterm infants
Evaluation of the Effects of Personalized Music Therapy on Preterm Infants Admitted to the Neonatal Intensive Care Unit (NICU) and on Parental Stress: A Pilot Randomized Crossover Controlled Trial
This pilot test compares recorded parental-voice music with quiet rest to see if it improves brain oxygenation and vital signs in preterm infants in the NICU.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 5 Days to 15 Days |
| Sex | All |
| Sponsor | Azienda Ospedaliera di Perugia Academic / other |
| Locations | 1 site (Perugia, PG) |
| Trial ID | NCT07295106 on ClinicalTrials.gov |
What this trial studies
This single-center pilot uses a randomized two-period crossover design in which each preterm infant receives Personalized Music Therapy (recorded parental singing/voice) and Quiet Rest in randomized order with a two-day washout. A trained music therapist records and processes parental voice files that are played during the PMT period while near-infrared spectroscopy (NIRS) collects cerebral tissue oxygenation index (TOI) and monitors record heart rate, respiratory rate, and oxygen saturation. Parental stress is measured at discharge with the Parental Stressor Scale: NICU (PSS:NICU). The trial aims to test feasibility, estimate outcome variance, and refine procedures for a larger definitive trial.
Who should consider this trial
Good fit: Preterm infants born at 28+0 to 36+6 weeks, aged 5–15 days, medically stable in the NICU at the Perugia site with written parental or guardian consent are ideal candidates.
Not a fit: Infants who are postoperative, have major complications (e.g., intraventricular hemorrhage, necrotizing enterocolitis, sepsis), congenital anomalies, or hypersensitivity to sound are unlikely to receive benefit from this intervention.
Why it matters
Potential benefit: If successful, the intervention could help stabilize cerebral oxygenation and autonomic measures in preterm infants and potentially reduce parental stress.
How similar studies have performed: Prior neonatal NIRS and parental-voice or music interventions have shown small-to-moderate and heterogeneous changes in cerebral oxygenation, providing some supportive but variable evidence.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Perugia, PG
- Neonatal Intensive Care Unit (NICU), Ospedale Santa Maria della Misericordia - Azienda Ospedaliera di Perugia — Perugia, Pg, Italy (Recruiting)
Study contacts
- Study coordinator: Fabrizio Faina
- Email: fabrizio.faina@unipg.it
- Phone: +39 075 585 8021
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.