Premature Family Music Therapy Intervention (PFMI) (PFMI)

Premature Family Music Therapy Intervention (PFMI): an Italian Protocol to Support Parenting, Attachment Bond and Preterm Development

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.

Study Overview

• Status: Recruiting
• Conditions: Music Therapy
• Intervention / Treatment: Other: Premature family music therapy intervention to support parenting, attachment bond and preterm development

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

• Study Type: Interventional
• Enrollment (Anticipated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Barbara S Sgobbi, MA; Phone Number: +390332299421; Email: barbarasgobbi@gmail.com
• Study Contact Backup: Name: Laura S Morlacchi, MD; Phone Number: +390332299420; Email: laura.morlacchi@asst-settelaghi.it

Study Locations

• Italy
  • Varese, Italy, 21100
    • Recruiting
    • Ospedale F. Del Ponte
    • Contact: Barbara Sgobbi; Phone Number: +390332299421; Email: barbarasgobbi@gmail.com
    • Contact: Laura Morlacchi, MD; Phone Number: +390332299420; Email: laura.morlacchi@asst-settelaghi.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 months to 1 year (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Music Therapy Intervention; This protocol is a Family Centered Care Music Therapy Intervention. The methodologies will provide early intervention from the first days of hospitalization in NICU and consist of music therapy sessions both "active" (parental chant, live music and lullaby) and "receptive" (listening to recorded tracks). The music therapy accompanies the newborn and the parents during the hospitalization and focuses its attention on the emotional-relational care, according to the different needs that they will develop over time.Therapy sessions will be performed starting from three times per week, on three different days of the week, during the entire hospitalization of the enrolled infants. After discharge music therapy treatment will be performed once a week until twelve months of corrected age. Stress level of infants and parents and neurobehavioral and neurological development of children will be assessed.	Other: Premature family music therapy intervention to support parenting, attachment bond and preterm development; We have structured an integrated psychological and music therapeutic protocol that aims to limit or overcome neonatal long-term developmental morbidities, promote parenting and attachment bond in preterm infants.
No Intervention: No music therapy intervention; Music therapy is not administered in this group. Control group (no music therapy). During the entire hospital stay, newborn babies will receive standard care in use in the neonatal intensive care unit.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HRV analysis	The heart rate variability is related to the interaction of the sympathetic nervous system (alarm system) and parasympathetic (vagal). HRV derives from the balance of Low Frequency (LF) and High Frequency (HF). LF parameter represents the Sympathetic System and is correlated to a state of stress, while HF parameter represents the Parasympathetic System and is correlated to a state of relaxation. The balance of the two parameters (represented by value 1), means that their relationship is a state of well-being.	through test completion, starting from 5 minutes before the test until 5 minutes after test ended
Oxygen's saturation	Monitor oxygen saturation by medical monitor in Neonatal Intensive Care and Neonatology.	through test completion, starting from 5 minutes before the test until 5 minutes after test ended

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stress level of the parents	Parenting Stress Index-Short Form (PSI-SF, Abidin, 1995; Italian version edited by Guarino et al., 2007) at 6-12 months of corrected age State-Trait Anxiety Scale (STAI; Spielberger, 1983; Italian validation of Pedrabissi and Santinello (1996) at 6-12 months of corrected age Beck Depression Inventory (BDI, Beck, 1967) at 6-12 months of corrected age	at 6 and 12 months of corrected age
Neuro-behavioral and neurological development of the child	Temperament detected by the test QUIT (Italian Questionnaires of Temperament Axia, 2002)	at 6-12 months of corrected age
Neuro-behavioral and neurological development of the child	General movements (GM). Using digital recording and analysis.	at 1-3-6-9-12 months of corrected age.
Neuro-behavioral and neurological development of the child	Griffiths Scale	12 months of corrected age

Collaborators and Investigators

• Sponsor: Ospedale di Circolo - Fondazione Macchi
• Investigators: Principal Investigator: Massimo Agosti, MD, Neonatologia, TIN e Pediatria Verbano- Ospedale F. del Ponte

Study record dates

Study Major Dates

• Study Start (Actual): April 30, 2021
• Primary Completion (Actual): September 1, 2021
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: April 1, 2020
• First Submitted That Met QC Criteria: April 2, 2020
• First Posted (Actual): April 6, 2020

Study Record Updates

• Last Update Posted (Actual): April 27, 2022
• Last Update Submitted That Met QC Criteria: April 19, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: HRV; Infants; NICU; Neurodevelopment; Music; Music therapy; Preterm
• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Premature Birth
• Other Study ID Numbers: 31 (Other Identifier: IASO Thessalias)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No