Premature Family Music Therapy Intervention (PFMI)

NCT ID: NCT04335240

Last Updated: 2022-04-27

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-30
• Study Completion Date: 2022-12-01

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

Conditions

Music Therapy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Premature family music therapy intervention to support parenting, attachment bond and preterm development

Intervention Type: OTHER

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 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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

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

• Minimum Eligible Age: 23 Weeks
• Maximum Eligible Age: 12 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ospedale di Circolo - Fondazione Macchi

OTHER

Sponsor Role: lead

Responsible Party

Barbara Sgobbi

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Massimo Agosti, MD

Role: PRINCIPAL_INVESTIGATOR

Neonatologia, TIN e Pediatria Verbano- Ospedale F. del Ponte

Locations

Ospedale F. Del Ponte

Varese, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Barbara S Sgobbi, MA

Role: CONTACT

barbarasgobbi@gmail.com

+390332299421

Laura S Morlacchi, MD

Role: CONTACT

laura.morlacchi@asst-settelaghi.it

+390332299420

Facility Contacts

Barbara Sgobbi

Role: primary

barbarasgobbi@gmail.com

+390332299421

Laura Morlacchi, MD

Role: backup

laura.morlacchi@asst-settelaghi.it

+390332299420

Other Identifiers

31

Identifier Type: -

Identifier Source: org_study_id