Personalized parental-voice music for preterm infants

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.