The Effects of Recorded Receptive Music Therapy on Oral Nutrition and the Well-being of the Italian Premature Baby
Condition: Music Therapy
MeSH terms: Premature Birth
Study type: Interventional

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.
    

Intervention name(s): Music therapy
Intervention type(s): Other
Intervention description(s): The effects of receptive music therapy on oral nutrition and the well-being of the Italian premature baby
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Music therapy; Hrv; Premature; Preterm; Music recorded receptive; Parents voice; feeding time; music therapist voice