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

• ClinicalTrials.gov Identifier: NCT04759170
• Recruitment Status: Completed
• First Posted: February 18, 2021
• Last Update Posted: April 20, 2022
• Sponsor: Ospedale di Circolo - Fondazione Macchi
• Information provided by (Responsible Party): Barbara Sgobbi, Ospedale di Circolo - Fondazione Macchi

Tracking Information

• First Submitted Date: January 28, 2021
• First Posted Date: February 18, 2021
• Last Update Posted Date: April 20, 2022
• Actual Study Start Date: August 30, 2020
• Actual Primary Completion Date: February 10, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: February 16, 2021)

Clinical stability by measuring Heart Rate Variability (HRV) [ Time Frame: 8 day ]

Evaluate and monitor the tolerance of recorded receptive music therapy on clinical stability parameter HRV

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: February 16, 2021)

• Effects of positive reinforcement carried out through the use of recorded receptive music therapy [ Time Frame: through study completion, an average of 20 weeks ]
  Evaluation of the achievement of exclusive oral sucking
• Effects of recorded receptive music therapy on positive reinforcement on the acquisition of food skills [ Time Frame: through study completion, an average of 20 weeks ]
  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. [ Time Frame: through study completion, an average of 20 weeks ]
  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. [ Time Frame: through study completion, an average of 20 weeks ]
  Assessment of the growth rate from the last day of treatment to discharge.

• Original Secondary Outcome Measures: Same as current

Current Other Pre-specified Outcome Measures (submitted: February 16, 2021)

Length of hospital stay after music therapy treatment [ Time Frame: through study completion, an average of 20 weeks ]

Length of hospital stay.

• Original Other Pre-specified Outcome Measures: Same as current

Descriptive Information

• 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
• 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.

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Participant); Primary Purpose: Treatment
• Condition: Music Therapy

Intervention

Other: Music therapy

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

Study Arms

• Mother Recorded Receptive Music Therapy Intervention
  The effects of recorded receptive music therapy on oral nutrition and the well-being of the Italian premature baby
  Intervention: Other: Music therapy
• Fother Recorded Receptive Music Therapy Intervention
  The effects of recorded receptive music therapy on oral nutrition and the well-being of the Italian premature baby
  Intervention: Other: Music therapy
• Music therapist Recorded Receptive Music therapy intervention
  The effects of recorded receptive music therapy on oral nutrition and the well-being of the Italian premature baby
  Intervention: Other: Music therapy
• No singing
  The effects of recorded receptive music therapy on oral nutrition and the well-being of the Italian premature baby
  Intervention: Other: Music therapy

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: February 16, 2021): 40
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: December 27, 2021
• Actual Primary Completion Date: February 10, 2021 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 23 Weeks to 34 Weeks (Child)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Italy

Administrative Information

• NCT Number: NCT04759170
• Other Study ID Numbers: 186
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Barbara Sgobbi, Ospedale di Circolo - Fondazione Macchi
• Original Responsible Party: Same as current
• Current Study Sponsor: Ospedale di Circolo - Fondazione Macchi
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Massimo Agosti, MD; Neonatologia, TIN e Pediatria Verbano- Ospedale F. del Ponte

• PRS Account: Ospedale di Circolo - Fondazione Macchi
• Verification Date: April 2022