Premature Family Music Therapy Intervention (PFMI)

Status Recruiting

Clinical Trial 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.

Clinical Trial 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 ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04335240
Study type	Interventional
Source	Ospedale di Circolo - Fondazione Macchi
Contact	Barbara S Sgobbi, MA
Phone	+390332299421
Email	barbarasgobbi@gmail.com
Status	Recruiting
Phase	N/A
Start date	April 30, 2021
Completion date	December 1, 2022

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Premature Family Music Therapy Intervention (PFMI) — PFMI

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms