The Effects of Pacifier Activated Lullaby in VLBW Preterm Infants
Condition: Music Therapy
MeSH terms: Premature Birth
Study type: Interventional

Summary: 
      Music and music therapy, live or recorded, has been introduced in the Neonatal Intensive Care
      Unit (NICU) of the Del Ponte hospital in Varese in addition to standard medical and nursing
      care, to improve premature neonates' neurophysiological development.

      Recent studies focused on the effects of the maternal voice or the entrained singing and live
      music, highlighting their benefits on neonates stress, on not-nutritive sucking and on the
      caloric intake.

      Aim of our study is to evaluate the effect of parents singing or musictherapist singing
      admistered by Pacifier Activated Lullaby (PAL) on infant's behavior and nutritional outcomes.

      Particularly, we will evaluate infants' Heart Rate Variability during music therapy session,
      exclusive oral feeding achievement, weigth increase and hospitalization in a group of preterm
      infants administered to PAL compared with a control group of preterm infants not exposed to
      PAL stimulus.
    

Detailed description: 
      A Prospective randomized controlled pilot study trial will be conducted. Infants will be
      evaluated at 32-34 post-conceptional weeks when the volume of milk assumed orally will be
      less than 50% of the total enteral intake.

      Infants with gestational age less than 34 weeks will be enrolled. After the request for
      informed consent, participants will be randomized randomly through computerized.

      The administration of the PAL and the reproduction of the relative voices will be performed
      by the music therapist.

      Objective of this study is to evaluate the tolerance (in terms of clinical stability,
      described through the HRV parameter) of the PAL device by the enrolled customers and
      investigate any benefits of the positive reinforcement purchased, through its use, on the
      acquisition of food skills and on the growth of preterms.

      Primary Outcome: Clinical Stability Using Heart Rate Variability (HRV) Measurement during the
      music therapy treatment.

      Secondary Outcomes: effects of positive reinforcement (obtained through the use of the device
      PAL) on the acquisition of food skills and the growth of preterm consumers.

      In particular:

        -  Evaluation of the achievement of the exclusive oral sucking

        -  Evaluation of the variation in the rate of meal intake between the beginning and the end
           of the intervention

        -  Assessment of the infant's weight gain in the 24 hours following stimulation

        -  Evaluation of the rate of growth from the last day of treatment to discharge.

        -  Duration of hospital stay.
    

Intervention name(s): The effects of Pacifier Activated Lullaby in very low birth weigt preterm infants. An italian music therapy intervention
Intervention type(s): Device
Intervention description(s): Positive reinforcement is an effective development strategy for improving the feeding skills of preterm infants. A brief intervention with the PAL device with pacifier that reproduces lullabies sung by both parents or by the music therapist could reduce the use of the feeding tube and the length of hospital stay in preterm infants. 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 to observe its possible effects on its well-being and its clinical stability.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Prospective randomized controlled trial, divided into four parallel groups of preterm infants
Masking: Double (Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Music therapy; Preterm; PAL; HRV; Parental voice