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The Effects of Pacifier Activated Lullaby in VLBW Preterm Infants — PAL  

Music Therapy Clinical Trial

Official title:
The Effects of Pacifier Activated Lullaby in VLBW Preterm Infants: an Italian Randomized Pilot Study

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04337476
Study type Interventional
Source Ospedale di Circolo - Fondazione Macchi
Contact
Status Completed
Phase N/A
Start date April 30, 2020
Completion date December 1, 2021
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