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Clinical Trials in Italy / NCT07295106
Recruiting Not applicable

Personalized Music Therapy for Preterm Infants

NCT07295106 · tracked via the Priya Life Science Italy tracker
Sponsor
Fabrizio Faina
Phase
Not applicable
Started
2025-10-13
Last updated
2025-12-19

Condition(s) studied

Infant, PrematureStress, Psychological

Investigational drug(s) / intervention(s)

Personalized Music Therapy (PMT)Quiet Rest

Personalized Music Therapy (PMT): Personalized Music Therapy (PMT): playback of the parent's recorded voice during Phase 2 (10 to 40 minutes) within a standardized 50 minute Period conducted in a low stimulation NICU room. Audio is prepared in advance by a trained music therapist (smoothing peaks, removing artifacts, setting a target level). Delivered via bedside speaker positioned approximately 30 cm from the infant's head; target intensity approximately 45 dBA (plus or minus 3 dB) at the infant's ear level. Phase 1 (0 to 9 minutes) and Phase 3 (40 to 50 minutes) are rest without added stimulation per protocol and are not part of the PMT exposure.

Quiet Rest: Quiet Rest: low stimulation rest during Phase 2 (10 to 40 minutes) within the same standardized 50 minute Period used for PMT. Phase 1 (0 to 9 minutes) and Phase 3 (40 to 50 minutes) are also rest without added stimulation. Room conditions and handling minimization match those used for PMT.

Study 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

Sex
ALL
Min age
5 Days
Max age
15 Days
Healthy volunteers
No
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.

Primary outcome measure(s)

  • TOI 21 to 25 min — Minutes 21-25 of each 50-minute Period (Phase 2)
    Mean tissue oxygenation index (TOI, percent) over minutes 21 to 25. Primary comparison is the within-participant difference (PMT minus Quiet Rest) in a two-sequence, two-period crossover.

Trial sites (1)

FacilityCityRegionStatus
Neonatal Intensive Care Unit (NICU), Ospedale Santa Maria della Misericordia - Azienda Ospedaliera di Perugia Perugia PG Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07295106 on ClinicalTrials.gov ↗ ← All trials in Italy