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The Effects of Recorded Receptive Music Therapy on Oral Nutrition and the Well-being of the Italian Premature Baby

Primary Purpose

Music Therapy

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Music therapy
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, Hrv, Premature, Preterm, Music recorded receptive, Parents voice, feeding time, music therapist voice

Eligibility Criteria

23 Weeks - 34 Weeks (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Infants with gestational age at birth between the 23rd and 34th week of gestation
  • Neonates with intraventricular hemorrhage (IVH)
  • Neonates with periventricular leukomalacia (PVL)

Exclusion Criteria:

  • Only newborns in ventilatory support at the time of evaluation
  • Newborns with maxillofacial malformations
  • Newborns will be evaluated when they reach 32 ° -34 ° post-conception weeks, the amount of milk taken orally (by sucking) must be less than 50% of the total enteral intake
  • Infants who have not passed the next hearing screening test using AABR (Brain Stem Automatic Response Test), which is expected to be performed after reaching the correct age term

Sites / Locations

  • Ospedale F. Del Ponte

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Other

Other

Other

Other

Arm Label

Mother Recorded Receptive Music Therapy Intervention

Fother Recorded Receptive Music Therapy Intervention

Music therapist Recorded Receptive Music therapy intervention

No singing

Arm Description

The effects of recorded receptive music therapy on oral nutrition and the well-being of the Italian premature baby

The effects of recorded receptive music therapy on oral nutrition and the well-being of the Italian premature baby

The effects of recorded receptive music therapy on oral nutrition and the well-being of the Italian premature baby

The effects of recorded receptive music therapy on oral nutrition and the well-being of the Italian premature baby

Outcomes

Primary Outcome Measures

Clinical stability by measuring Heart Rate Variability (HRV)
Evaluate and monitor the tolerance of recorded receptive music therapy on clinical stability parameter HRV

Secondary Outcome Measures

Effects of positive reinforcement carried out through the use of recorded receptive music therapy
Evaluation of the achievement of exclusive oral sucking
Effects of recorded receptive music therapy on positive reinforcement on the acquisition of food skills
Evaluation of the variation in the speed of meal intake between the beginning and the end of the intervention.
Effects of the use of recorded receptive music therapy on the acquisition in skill of preterm infants.
Evaluation of the weight gain of the newborn in the 24 hours following stimulation.
Effects of positive reinforcement carried out through the use of recorded receptive music therapy on the acquisition of food the growth of preterm infants.
Assessment of the growth rate from the last day of treatment to discharge.

Full Information

First Posted
January 28, 2021
Last Updated
April 19, 2022
Sponsor
Ospedale di Circolo - Fondazione Macchi
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1. Study Identification

Unique Protocol Identification Number
NCT04759170
Brief Title
The Effects of Recorded Receptive Music Therapy on Oral Nutrition and the Well-being of the Italian Premature Baby
Official Title
The Effects of Recorded Receptive Music Therapy on Oral Nutrition and the Well-being of the Italian Premature Baby: Prospective Randomized Controlled Study Mom, Dad and Music Therapist Singing Voice
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
August 30, 2020 (Actual)
Primary Completion Date
February 10, 2021 (Actual)
Study Completion Date
December 27, 2021 (Actual)

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
Yes

5. Study Description

Brief Summary
The investigators have thought with a dedicated research group, to deepen the use of receptive music therapy so that it can improve the non-nutritive sucking of premature babies through listening to lullabies sung by parents and by the music therapist, which can reduce the use feeding tube and the negative effects on stress or growth of the newborn. The acquisition of oral skills and the achievement of a complete autonomous suction are of fundamental importance for the discharge of the preterm infant. Some studies published in the literature suggest that listening to the mother's voice and lullabies can represent a positive auditory stimulus for babies to support nutritional and non-nutritive sucking (NNS). Positive reinforcement is an effective development strategy for improving the feeding skills of preterm infants. A brief receptive music therapy intervention with the infant's personal pacifier that plays lullabies sung by both parents or by the music therapist could reduce the use of the feeding tube and the length of hospitalization. The possible negative effects of this stimulation on infant stress or growth remain to be explored. The aim of this study is not only to evaluate the benefits of positive reinforcement on the nutritional sucking competence of the premature baby, but at the same time also to observe the possible effects on his well-being and on his clinical stability.
Detailed Description
In preterm infant, oral feeding requires significant maturation of the nervous system to support coordination of the oropharyngeal muscles and breathing. Additionally, the energy expenditure required by nutritional sucking attempts further complicates the acquisition of oral feeding skills and must be balanced by caloric intake to achieve sufficient growth. Achievement of exclusive autonomous sucking typically occurs only between 34 and 36 post-conception weeks. However, delays in achieving full oral sucking are common and may prolong the infant's hospitalization.Non-nutritive sucking (NNS) is a coordinated motor skill that can be taught through an educational activity that conditions neuronal responses through positive reinforcement.The international literature demonstrates that, through a behavioral approach, the use of the pacifier during non-nutritive sucking promotes nutritional sucking in preterm infants, improving their attachment and bottle feeding, and determines the reduction of the length of stay in intensive care. and improved general well-being of the newborn.The use of receptive music therapy can therefore be supportive and represent a positive reinforcement for the development and acquisition of oral and nutritional skills of the preterm infant. By taking advantage of non-nutritive sucking it is possible to improve the suckling capacity of the newborn, his feeding speed, weight gain and consequently reduce the length of hospital stay. It is essential to achieve this result without negatively affecting the well-being and stability of the preterm infant. Although musical studies in premature infants are limited, a 2014 study published in Pediatrics highlighted how music-specific and the maternal voice can positively reinforce the behavioral and neural responses of the preterm infant.On the other hand, the possible similar effects of reproduction, through the use of receptive music therapy of the song of the father and / or the music therapist, have not yet been investigated. The investigators therefore decided to design a prospective, randomized and controlled study to test the hypothesis that the parental (maternal and / or paternal) and / or music therapist's chant influences the well-being and / or stress of the newborn, evaluated through the parameter Heart Rate Variability (HRV), NNS development, nutritional sucking capacity, weight growth, and length of stay in premature infants compared to a control group of infants not subjected to sound stimulation . 40 premature babies will be recruited to be divided into 4 groups, after computerized randomization: n. 3 musical groups (mother song, father song, music therapist song) and 1 control group (not subjected to musical stimulation). Infants with gestational age at birth between the 23rd and 34th week of gestation will be included. Neonates with intraventricular hemorrhage (IVH) and periventricular leukomalacia (PVL) may also be enrolled. Only newborns in ventilatory support at the time of evaluation and newborns with maxillofacial malformations that may interfere with the ability to suck will be excluded from enrollment. Newborns will be evaluated when they reach 32 ° -34 ° post-conception weeks, the amount of milk taken orally (by sucking) must be less than 50% of the total enteral intake.Infants who have not passed the subsequent hearing screening test using AABR (Brain Stem Automatic Response Test) will be excluded from the analysis, which is expected to be performed after reaching the correct age limit. OUTCOMES Positive reinforcement is an effective development strategy for improving the feeding skills of preterm infants. A short receptive music therapy intervention that reproduces lullabies sung by both parents or by the music therapist could positively influence the acquisition of nutritional skills and the growth of the preterm infant. Evaluating how this can affect the clinical stability of the newborn (and therefore on his state of stress, measured in terms of HRV) represents a fundamental and primary point to explore, in order to be able to make the possible use of receptive music therapy applicable in the strategy of positive reinforcement. The objective of this study is therefore to evaluate the tolerance of a receptive music therapy intervention (in terms of clinical stability, assessed through the HRV parameter) by the enrolled infants and to investigate any benefits of positive reinforcement obtained, through its use, on the acquisition of nutrition and growth skills of preterm infants. Primary outcomes: clinical stability by measuring Heart Rate Variability (HRV) • The primary objective of this study is to evaluate and monitor the tolerance of receptive music therapy (in terms of measurement of the clinical stability parameter HRV) by infants during music therapy treatment. Secondary outcomes: effects of positive reinforcement (carried out through the use of receptive music therapy) on the acquisition of food skills and the growth of preterm infants. In particular: Evaluation of the achievement of exclusive oral sucking (determined as a week post-conception and / or days of life). Evaluation of the variation in the speed of meal intake between the beginning and the end of the intervention (measured as the volume of the nutritional intake in milliliters divided by the time in minutes required for consumption). Evaluation of the weight gain of the newborn in the 24 hours following stimulation (expressed as a percentage of weight gain from enrollment). Assessment of the growth rate from the last day of treatment to discharge. Length of hospital stay.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Music Therapy
Keywords
Music therapy, Hrv, Premature, Preterm, Music recorded receptive, Parents voice, feeding time, music therapist voice

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mother Recorded Receptive Music Therapy Intervention
Arm Type
Other
Arm Description
The effects of recorded receptive music therapy on oral nutrition and the well-being of the Italian premature baby
Arm Title
Fother Recorded Receptive Music Therapy Intervention
Arm Type
Other
Arm Description
The effects of recorded receptive music therapy on oral nutrition and the well-being of the Italian premature baby
Arm Title
Music therapist Recorded Receptive Music therapy intervention
Arm Type
Other
Arm Description
The effects of recorded receptive music therapy on oral nutrition and the well-being of the Italian premature baby
Arm Title
No singing
Arm Type
Other
Arm Description
The effects of recorded receptive music therapy on oral nutrition and the well-being of the Italian premature baby
Intervention Type
Other
Intervention Name(s)
Music therapy
Intervention Description
The effects of receptive music therapy on oral nutrition and the well-being of the Italian premature baby
Primary Outcome Measure Information:
Title
Clinical stability by measuring Heart Rate Variability (HRV)
Description
Evaluate and monitor the tolerance of recorded receptive music therapy on clinical stability parameter HRV
Time Frame
8 day
Secondary Outcome Measure Information:
Title
Effects of positive reinforcement carried out through the use of recorded receptive music therapy
Description
Evaluation of the achievement of exclusive oral sucking
Time Frame
through study completion, an average of 20 weeks
Title
Effects of recorded receptive music therapy on positive reinforcement on the acquisition of food skills
Description
Evaluation of the variation in the speed of meal intake between the beginning and the end of the intervention.
Time Frame
through study completion, an average of 20 weeks
Title
Effects of the use of recorded receptive music therapy on the acquisition in skill of preterm infants.
Description
Evaluation of the weight gain of the newborn in the 24 hours following stimulation.
Time Frame
through study completion, an average of 20 weeks
Title
Effects of positive reinforcement carried out through the use of recorded receptive music therapy on the acquisition of food the growth of preterm infants.
Description
Assessment of the growth rate from the last day of treatment to discharge.
Time Frame
through study completion, an average of 20 weeks
Other Pre-specified Outcome Measures:
Title
Length of hospital stay after music therapy treatment
Description
Length of hospital stay.
Time Frame
through study completion, an average of 20 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
23 Weeks
Maximum Age & Unit of Time
34 Weeks
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Infants with gestational age at birth between the 23rd and 34th week of gestation Neonates with intraventricular hemorrhage (IVH) Neonates with periventricular leukomalacia (PVL) Exclusion Criteria: Only newborns in ventilatory support at the time of evaluation Newborns with maxillofacial malformations Newborns will be evaluated when they reach 32 ° -34 ° post-conception weeks, the amount of milk taken orally (by sucking) must be less than 50% of the total enteral intake Infants who have not passed the next hearing screening test using AABR (Brain Stem Automatic Response Test), which is expected to be performed after reaching the correct age term
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

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

The Effects of Recorded Receptive Music Therapy on Oral Nutrition and the Well-being of the Italian Premature Baby

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