Premature Family Music Therapy Intervention (PFMI)

NCT04335240 | Unknown

• 1 other identifier: 31
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Music Therapy

Keywords

Music therapy; NICU; Preterm; Infants; Music; HRV; Neurodevelopment

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Stress level of the parents

  at 6 and 12 months of corrected age

• Neuro-behavioral and neurological development of the child

  at 6-12 months of corrected age

• Neuro-behavioral and neurological development of the child

  at 1-3-6-9-12 months of corrected age.

• Neuro-behavioral and neurological development of the child

  12 months of corrected age

Study Arms (2)

Music Therapy Intervention

EXPERIMENTAL

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

No music therapy intervention

NO 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.

Interventions

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

Music Therapy Intervention

Eligibility Criteria

• Age: 23 Weeks - 12 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Born between 22+6- and 32-weeks postmenstrual age
• Weight less than 1500 g
• Free from major congenital defects
• Free from cerebral and/or intraventricular hemorrhage
• Singleton or twin gestation
• No sensorineural hearing loss (at discharge, passed bilateral hearing screening)
• Free from Necrotizing enterocolitis
• Free from severe retinopathy
• No asphyxiated
• \. No terms of surgical relevance 12. Born from HIV negative and drug free mothers

You may not qualify if:

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

Sponsors & Collaborators

• Ospedale di Circolo - Fondazione Macchi: lead

Study Sites (1)

Ospedale F. Del Ponte

Varese, 21100, Italy

RECRUITING

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Massimo Agosti, MD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Barbara S Sgobbi, MA

CONTACT

+390332299421; barbarasgobbi@gmail.com

Laura S Morlacchi, MD

CONTACT

+390332299420; laura.morlacchi@asst-settelaghi.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: A prospective randomized controlled trial will be conducted. Infants will be divided in two subgroups: an intervention group (that will undergo music therapy treatment) and a control group. To evaluate the effectiveness of the protocol, the effects of treatment in the short- and long-term period will be evaluated, with particular reference to the clinical course, the neuro-behavioral development of the premature baby and the relationship with his parents.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Prospective randomized controlled trial

Study Record Dates

• First Submitted: April 1, 2020
• First Posted: April 6, 2020
• Study Start: April 30, 2021
• Primary Completion: September 1, 2021
• Study Completion: December 1, 2022
• Last Updated: April 27, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)