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Premature Family Music Therapy Intervention (PFMI) (PFMI)

Primary Purpose

Music Therapy

Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Premature family music therapy intervention to support parenting, attachment bond and preterm development
Sponsored by
Ospedale di Circolo - Fondazione Macchi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Music Therapy focused on measuring Music therapy, NICU, Preterm, Infants, Music, HRV, Neurodevelopment

Eligibility Criteria

23 Weeks - 12 Months (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Ospedale F. Del PonteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Music Therapy Intervention

No music therapy intervention

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
Oxygen's saturation
Monitor oxygen saturation by medical monitor in Neonatal Intensive Care and Neonatology.

Secondary Outcome Measures

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
Neuro-behavioral and neurological development of the child
Temperament detected by the test QUIT (Italian Questionnaires of Temperament Axia, 2002)
Neuro-behavioral and neurological development of the child
General movements (GM). Using digital recording and analysis.
Neuro-behavioral and neurological development of the child
Griffiths Scale

Full Information

First Posted
April 1, 2020
Last Updated
April 19, 2022
Sponsor
Ospedale di Circolo - Fondazione Macchi
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1. Study Identification

Unique Protocol Identification Number
NCT04335240
Brief Title
Premature Family Music Therapy Intervention (PFMI)
Acronym
PFMI
Official Title
Premature Family Music Therapy Intervention (PFMI): an Italian Protocol to Support Parenting, Attachment Bond and Preterm Development
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 30, 2021 (Actual)
Primary Completion Date
September 1, 2021 (Actual)
Study Completion Date
December 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ospedale di Circolo - Fondazione Macchi

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Music Therapy
Keywords
Music therapy, NICU, Preterm, Infants, Music, HRV, Neurodevelopment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective randomized controlled trial
Masking
ParticipantCare ProviderInvestigator
Masking Description
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.
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Music Therapy Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
No music therapy intervention
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Premature family music therapy intervention to support parenting, attachment bond and preterm development
Intervention Description
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.
Primary Outcome Measure Information:
Title
HRV analysis
Description
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.
Time Frame
through test completion, starting from 5 minutes before the test until 5 minutes after test ended
Title
Oxygen's saturation
Description
Monitor oxygen saturation by medical monitor in Neonatal Intensive Care and Neonatology.
Time Frame
through test completion, starting from 5 minutes before the test until 5 minutes after test ended
Secondary Outcome Measure Information:
Title
Stress level of the parents
Description
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
Time Frame
at 6 and 12 months of corrected age
Title
Neuro-behavioral and neurological development of the child
Description
Temperament detected by the test QUIT (Italian Questionnaires of Temperament Axia, 2002)
Time Frame
at 6-12 months of corrected age
Title
Neuro-behavioral and neurological development of the child
Description
General movements (GM). Using digital recording and analysis.
Time Frame
at 1-3-6-9-12 months of corrected age.
Title
Neuro-behavioral and neurological development of the child
Description
Griffiths Scale
Time Frame
12 months of corrected age

10. Eligibility

Sex
All
Minimum Age & Unit of Time
23 Weeks
Maximum Age & Unit of Time
12 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria, Preterm infants born, will be eligible for the study, if they will be: 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 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: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Barbara S Sgobbi, MA
Phone
+390332299421
Email
barbarasgobbi@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Laura S Morlacchi, MD
Phone
+390332299420
Email
laura.morlacchi@asst-settelaghi.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Massimo Agosti, MD
Organizational Affiliation
Neonatologia, TIN e Pediatria Verbano- Ospedale F. del Ponte
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ospedale F. Del Ponte
City
Varese
ZIP/Postal Code
21100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Barbara Sgobbi
Phone
+390332299421
Email
barbarasgobbi@gmail.com
First Name & Middle Initial & Last Name & Degree
Laura Morlacchi, MD
Phone
+390332299420
Email
laura.morlacchi@asst-settelaghi.it

12. IPD Sharing Statement

Plan to Share IPD
No

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Premature Family Music Therapy Intervention (PFMI)

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