Personalized Music Therapy for Preterm Infants
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age5-15
SponsorFabrizio Faina
About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Crossover
Treatments tested in this trial
Personalized Music Therapy (PMT)
BehavioralPersonalized 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
BehavioralQuiet 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.
Treatment groups
20 Participants
are divided into 2 treatment groupsGroup A: Sequence AB: PMT then Quiet RestExperimental treatment 2 interventions
Group B: Sequence BA: Quiet Rest then PMTExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
TOI 21 to 25 min
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.
Time frame
Minutes 21-25 of each 50-minute Period (Phase 2)Secondary outcomes
1
TOI 5 to 9 min
Mean tissue oxygenation index (TOI, percent) over minutes 5 to 9. Within-participant difference (PMT minus Quiet Rest).
Time frame
Minutes 5-9 of each 50-minute Period (Phase 1)2
TOI 46 to 50 min
Mean tissue oxygenation index (TOI, percent) over minutes 46 to 50. Within-participant difference (PMT minus Quiet Rest).
Time frame
Minutes 46-50 of each 50-minute Period (Phase 3)3
HR 5 to 9 min
Mean heart rate (HR, beats per minute) over minutes 5 to 9. Within-participant difference (PMT minus Quiet Rest).
Time frame
Minutes 5-9 of each 50-minute Period (Phase 1)4
HR 21 to 25 min
Mean heart rate (HR, beats per minute) over minutes 21 to 25. Within-participant difference (PMT minus Quiet Rest).
Time frame
Minutes 21-25 of each 50-minute Period (Phase 2)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Fabrizio Faina
Lead sponsor
Azienda Ospedaliera di Perugia
Sponsor institution
University Of Perugia
Collaborator
Source ClinicalTrials.gov