Clinical trial NCT04335240: Premature Family Music Therapy Intervention (PFMI)
Official title: Premature Family Music Therapy Intervention (PFMI): an Italian Protocol to Support Parenting, Attachment Bond and Preterm Development
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Music Therapy
Keywords: Music therapy
NICU
Preterm
Infants
Music
HRV
Neurodevelopment
Lead sponsor: Ospedale di Circolo - Fondazione Macchi
Sponsor class: OTHER
First posted: 2020-04-06
Enrollment: 90
Sex: ALL
Minimum age (years): 23
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective randomized controlled trial
Primary purpose: TREATMENT

Brief summary: The music therapy intervention it is dedicated to premature baby and their family at the Neonatal Intensive Care Unit (NICU)of the Woman-Child department "Hospital Del Ponte". In NICU an integrated psychological and music therapeutic protocol has been structured. The protocol aims to limit or overcome long-term developmental morbidities, promote parenting and attachment bond in preterm infants. Protocol is named "Premature family music therapy intervention (PFMI): an Italian protocol to support parenting, attachment bond and preterm development". The methodologies will provide early intervention from the first days of hospitalization in NICU and use music therapy sessions "active" (chant parental, live music and lullaby) and "receptive" (listening to recorded tracks). Such therapy becomes a support for the born prematurely and her parents during hospitalization and after discharge. The music therapy accompanies the newborn and his parents during the hospitalization and focuses its attention on the emotional-relational care, according to the different needs of babies and parents.

This protocol it is a Family Centered Care Music Therapy Intervention.

Detailed description: All infants will be enrolled when in stable clinical condition within two weeks after birth. Therapy sessions will take place minimum three times per week on three different days of the week directly at the unit during the entire hospitalization until discharge. After discharge music therapy treatment will be performed once a week until twelve months of corrected age.

The infant's wellbeing and relaxation during each session of music therapy will be measured using the following parameters:

HRV (Heart Rate Variability) analysis Oxygen's saturation Stress level of the child

Infants will be followed till 12 months of corrected age. Investigators will assess:

Neuro-behavioral and neurological development of the child Stress level of the parents

Eligibility criteria: Inclusion Criteria, Preterm infants born, will be eligible for the study, if they will be:

1. Born between 22+6- and 32-weeks postmenstrual age
2. Weight less than 1500 g
3. Free from major congenital defects
4. Free from cerebral and/or intraventricular hemorrhage
5. Singleton or twin gestation
6. No sensorineural hearing loss (at discharge, passed bilateral hearing screening)
7. Free from Necrotizing enterocolitis
8. Free from severe retinopathy
9. No asphyxiated

11. No terms of surgical relevance 12. Born from HIV negative and drug free mothers

Exclusion Criteria, we will exclude infants whose mothers will be:

1. Affected by drug dependence
2. Affected by psychosis or other severe mental health problems
3. Unable to adequately speak/understand Italian language
4. Younger than 18 years of age
5. Physically unable to participate

Primary outcomes:
measure: HRV analysis
timeFrame: through test completion, starting from 5 minutes before the test until 5 minutes after test ended
measure: Oxygen's saturation
timeFrame: through test completion, starting from 5 minutes before the test until 5 minutes after test ended
Secondary outcomes:
measure: Stress level of the parents
timeFrame: at 6 and 12 months of corrected age
measure: Neuro-behavioral and neurological development of the child
timeFrame: at 6-12 months of corrected age
measure: Neuro-behavioral and neurological development of the child
timeFrame: at 1-3-6-9-12 months of corrected age.
measure: Neuro-behavioral and neurological development of the child
timeFrame: 12 months of corrected age
Other outcomes:
Locations:
city: Varese
country: Italy
facility: Ospedale F. Del Ponte
Study officials:
affiliation: Neonatologia, TIN e Pediatria Verbano- Ospedale F. del Ponte
name: Massimo Agosti, MD
role: PRINCIPAL_INVESTIGATOR
References: